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Biotech Boot Camp
Session 3 – Regulatory
Presenter: Nick Weston
Melbourne, Brisbane, Sydney
28 May – 18 June, 2014
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
2
Session 3 Agenda
Regulatory
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
3
Session 3 Agenda
Regulatory
• Prescription medicine regulation
• prescription medicines
• over the counter medicines
• complementary medicines
• blood, blood components and plasma derivatives
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
Session 3 Agenda
Regulatory
4
Prescription medicine regulation
5
Examples
• Vaccines
• Antibiotics
• Antivenines
• Immunoglobulins
• MaBs
• Anticoagulants
• Hormones (eg: insulin, HGH)
• Enzymes (eg: pancreatin)
• Blood products
Prescription medicine regulation
6
Background
The Therapeutic Goods Administration (TGA) administers
the Therapeutic Goods Act 1989 (Cth) and the Therapeutic
Goods Regulations 1993 (Cth)
The mission statement of the TGA
‘To ensure the safety, quality and efficacy of therapeutic
goods available in Australia at a standard equal to that of
comparable countries, and that pre-market assessment
of therapeutic goods is conducted within a reasonable
time.”
Prescription medicine regulation
7
Background
The TGA is accountable for the quality, safety, efficacy and
timely availability of drugs and medical devices in Australia
Performance targets for TGA drug evaluation and approval
were set and are included in the Regulations
The TGA operates on a 100% cost recovery basis
Prescription medicine regulation
8
Background
Before a drug (prescription or non-prescription), medical
device, vitamin, nutritional, ‘TCM’, ‘alternative medicine’ or
herbal product can be marketed in, imported to, or exported
from Australia it must be listed on the Australian Register of
Therapeutic Goods (ARTG) by the TGA
New chemical entities and applications which require
expert advice are referred to the Advisory Committee on
Prescription Medicines (ACPM) for its non-binding
recommendations
Prescription medicine regulation
9
Background
The TGA’s accountability includes an acceptance of a
balance between safety and efficacy
There is no such thing as a totally safe drug, and the
approval process has regard to a risk / benefit ratio
This requires a detailed evaluation of the data supplied by
the company sponsoring an application for the listing of a
particular drug
Prescription medicine regulation
10
Approach for ARTG listing – 8 phases
Generally, since 2010 all drug applications have to go
through an eight stage process involving:
• A ‘pre-submission’ of application planning phase
• Submission phase
• First round assessment
• Section 31 response period
• Second round assessment
• Expert advisory review
• Decision phase
• Post-decision phase
Prescription medicine regulation
11
Approach for ARTG listing – Pre-submission phase
At the Pre-submission planning phase:
• The applicants provide the TGA (before the 1st of a month) with
planning data in the Pre-submission planning form (PPF) at least 2¼
months prior to lodgement of the Submission
• dossier must include general submission information as well as
information about the proposed application type and details of the
quality, nonclinical and clinical evidence that will be provided in the
dossier
Prescription medicine regulation
12
Approach for ARTG listing – Pre-submission phase
At the Pre-submission planning phase:
• If the TGA considers a PPF complete and acceptable, the applicant
will receive a Planning letter that provides
• key dates for the phases and milestones of the regulatory process for
the application
• feedback from the TGA on justifications or other aspects affecting the
application
• Any specific conditions affecting dossier lodgment
Prescription medicine regulation
13
Approach for ARTG listing – Submission phase
At the Submission phase:
• The applicant must lodge (by the 7th or 14th of the month)
a complete dossier to the TGA for evaluation, there being
no opportunity to deliver new data after the submission
date except as provided by the Act (eg new safety data)
• TGA will then:
• check to see the dossier complies with Australian guidelines
• Provide a Notification letter advising whether the application has
been accepted for evaluation or not
• Invoice the Sponsor for 75% of the evaluation fee
Prescription drug regulation
14
Approach for ARTG listing – First round assessment
phase
At the First-round assessment phase the TGA (or
sometimes external evaluators) evaluate all dossier
content, such as
• pharmaceutical and chemical data
• animal pharmacology and toxicology data
• clinical data
If required a consolidated s.31 request for information will
be prepared in the final month of the phase and sent to the
applicant on the date set out in the Planning letter
Prescription drug regulation
15
Approach for ARTG listing – Consolidated s.31 request
response phase
What is a s.31 request?
Under s.31 of the Act the TGA can request information or documents
relating to:
• the formulation of the goods
• the composition of the goods
• the design specifications of the goods
• the quality of the goods
• manufacture method or procedures
Prescription medicine regulation
16
Approach for ARTG listing – Consolidated s.31 request
response phase
What is a s.31 request?
• the presentation of the goods
• the safety and efficacy of the goods for the purposes for which they
are to be used
• whether the goods comply with conditions (if any) on the registration
of the goods
• the conformity of the goods to an applicable standard
Prescription medicine regulation
17
Approach for ARTG listing – Consolidated s.31 request
response phase
What is a s.31 request?
• whether either of the following has not been complied with:
• an applicable provision of the Therapeutic Goods Advertising Code;
• any other requirement relating to advertising
• whether the goods are being supplied in imported into or exported
from Australia
• the regulatory history of the goods in another country
• any other matter prescribed by the regulations for the purposes of
s.31 in relation to goods of that kind
Prescription medicine regulation
18
Approach for ARTG listing – Consolidated s.31 request
response phase
The s.31 request response period closes at the end of this
phase
• Applicants nominate whether they will respond to the s.31 request
within 30 or 60 days as confirmed in the Planning letter
• If the applicant does not respond by the date in the Planning letter,
TGA evaluators complete the evaluation based on the initial dossier
• The TGA evaluators conduct unit reviews and prepare/coordinate
reports then prepare the first round assessment
• The Applicant has an opportunity to review the first round
assessment reports for factual correctness
Prescription medicine regulation
19
Approach for ARTG listing – Second round assessment
phase
At the Second round assessment phase the TGA
• Evaluators consider the s.31 response (if any) and finalise the
evaluation reports
• Where outstanding issues are identified they will be included in the
evaluation reports for consideration by the TGA’s delegate
• holds pre- ACPM consultations with the applicant
• prepares approved product information (PI) and considers consumer
product information (CPI) and a risk management plan (RMP)
• Sends to the applicant the outcome of the assessments
Prescription medicine regulation
20
Approach for ARTG listing – Expert advisory review
TGA will then submit the final package of summaries and
recommendations to the Advisory Committee on
Prescription Medicines (ACPM) [formerly Australian Drug
Evaluation Committee (ADEC)] (which meets 6 times/year)
The ACPM committee is a group of doctors appointed by
the Minister to advise on the suitability of drugs for
marketing in Australia
TGA takes into consideration the advice received from the
ACPM when making a final recommendation
Prescription medicine regulation
21
Approach for ARTG listing – Expert advisory review
Typically, the ACPM committee will review and advise on
only NCEs, new routes of administration, new fixed
combinations, new therapeutic indications or changes in
patient groups
Applications not typically referred to the ACPM include
generic products, new formulations, new strengths or
reformulations of existing products unless the TGA has
recommended a rejection of the application or when there
are complex clinical issues
Prescription medicine regulation
22
Approach for ARTG listing – Expert advisory review
The delegate prepares a letter to ACPM if independent
advice on aspects of an application is sought
Applicants have an opportunity to
• prepare a pre-ACPM response addressing issues raised in the
delegates letter to ACPM
• review the second round assessment reports for factual content
The ACPM non-binding advice is finalised and sent to the
applicant by the 15th of the month of the meeting
Prescription medicine regulation
23
Approach for ARTG listing – Decision phase
At the Decision phase the TGA:
• makes a final decision
• negotiates and finalises conditions of registration
• advises the applicant
• sends an invoice for the final 25% of evaluation fee
• advises drug information centres, forensic laboratories,
and so on if an NCE is involved
If the delegate proposes to reject an application the
reasons for decision are included in the letter of decision,
with an explanation of appeal rights
Prescription drug regulation
24
Approach for ARTG listing – Decision phase
There are three main avenues of appeal:
• the decision can be reviewed under s.60 of the Act by the Minister (or
one of the Minister’s delegates within the Department)
• an application to the Administrative Appeals Tribunal (AAT) for
administrative review may be made within 28 calendar days of the
Minister’s decision regarding a section 60 appeal
• An application to the Federal Court of Australia on legal grounds may
be brought at any time
Prescription drug regulation
25
Approach for ARTG listing – Registration
At the Post-decision (formerly called Registration) phase
• the Sponsor applies to register (or vary) the product on
the ARTG
• TGA allocates an ‘AustR number’
• where applicable TGA will prepare a draft Australian
Public Assessment Report for prescription medicines
(AusPAR) provides information about the evaluation of a
prescription medicine and the considerations that led the
TGA to approve or not
• supply is then permitted
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture
• Aquaculture
Session 3 Agenda
Regulatory
26
• Prescription medicine regulation
• Biologicals
• tissue based products (skin and bone)
• human stem cells
• cell-based products
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
Session 3 Agenda
Regulatory
27
Biologicals
28
Definition
A good that comprises, contains or is derived from human
cells or human tissues and is used to:
• treat or prevent disease
• diagnose the condition of a person
• influence, inhibit or modify a physiological process in a
person
• test the susceptibility of a person to a disease or ailment
• replace or modify parts in the anatomy of a person
Biologicals
29
Examples
• Tissue based products (eg: bone, skin, collagen, ocular, CV)
• Cell based products (eg: human stem cells, T cells, cartilage cells)
• Combined cell and tissue products (eg: collagen matrices for local
delivery, metal stent coated with a matrix and endothelial cells)
Not regulated by the TGA:
• Fresh viable organs
• IVF
• Fresh haematopoietic progenitor cells (eg: bone marrow transplants)
• Autologous undifferentiated cells and tissues made by a medical
practitioner used to perform the same basic function
Biologicals
30
Background
Before a biological can be marketed in, imported to, or
exported from Australia it must be listed on the Australian
Register of Therapeutic Goods (ARTG) by the TGA
Applications which require expert advice are referred to the
Advisory Committee on Biologicals (ACB) for its non-
binding recommendations
Biologicals
31
Regulatory framework and formal guidance
Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
Therapeutic Goods (Charges) Regulations 1990
Therapeutic Goods (Things that are not biologicals)
Determination No. 1 of 2011
Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
Therapeutic Goods Orders (product standards for
biologicals)
The Australian Regulatory Guidelines for Biologicals
31 http://www.tga.gov.au/industry/legislation.htm
Biologicals
32
Classes
Higher
risk
Lower
risk
Biological classification Example
• Class 1: If declared in s.16 of TG
Regs
• None yet
• Class 2: simple preparation for like-
for-like biological repairs
• Milled bone for allograft
• Acellular skin for wound covering
• Class 3: more complex preparation
for but does not change an inherent
biological property
• Mesenchymal stem cells for graft v
host disease
• Demineralised cadaveric bone mixed
with antibiotic carrier
• Cultured fibroblasts for skin repair
• Class 4: complex and changes
biological properties
• GM T cells for specific virus infections
• Dermal fibroblasts transformed for
skeletal muscle repair
• Bone marrow stem cells for cardiac
repair
Biologicals
33
Approach for ARTG listing – summary of phases
Generally, once the TGA has prepared the relevant
standards and guidelines, all biological applications have to
go through a four stage process involving:
• Preparation and lodgement of dossier
• Evaluation (with expert advisory review by ACB if required)
• Decision phase
• Finalisation
Biologicals
34
Approach for ARTG listing – Preparation of dossier and
lodgment phase
At the Preparation and dossier lodgment phase:
• The biological may first come to the attention of the TGA when an
application for marketing is received or when an Australian clinical
trial is being planned
• For clinical trials, the applicant may submit preliminary data for
evaluation to the TGA (CTX scheme) or notify the TGA (CTN
scheme) that the trial has been approved by an institutional ethics
committee
• The dossier needs to evidence the method of manufacture and
method of use so that a risk assessment can be performed
Biologicals
35
Approach for ARTG listing – Evaluation phase
At the Evaluation phase:
• The dossier submission is evaluated based on the evidence it
contains to ensure compliance with any default standards (such as
pharmacopoeial monographs), product-specific standards (eg: TGO
83 – Standards for human musculoskeletal tissue) or some
requirements of TGO 86 (Standards for human skin) may apply and
TGO 87 (labelling)
• Labelling for example is vital for quality data to allow donor
traceability, evidence of donor selection, validation of testing for
viruses, control of manufacturing and transportation, stability and
traceable bio-burden (microbial growth) testing
Biologicals
36
Approach for ARTG listing – Evaluation phase
At the Evaluation phase:
• Compliance with all other dossier requirements for a biological in its
relevant class is assessed, including sections on nonclinical and
clinical development
• Nonclinical data will be evaluated by toxicologists for biological
dynamics and kinetics, lab data re efficacy, tox data and
tumorgenicity
• Clinical data is typically reviewed by a physician
• The level of detail in the dossier should correspond to the potential
risk that the product poses to the recipient
Biologicals
37
Approach for ARTG listing – Evaluation phase
At the Evaluation phase:
• Like medicines, biologicals are required to be manufactured
according to Good Manufacturing Practice (GMP)
• Compliance with manufacturing principles is required, including the
Australian Code of GMP for human blood and tissues
• All manufacturers are inspected to ensure GMP-compliance
• This is demonstrated by a current TGA manufacturing licence or
clearance
Biologicals
38
The Advisory Committee on Biologicals
The Advisory Committee on Biologicals (ACB) advises and
makes recommendations to the TGA (formally, to the
Health Minister or the Secretary of the health department)
on:
• which biologicals can be included on the ARTG
• variations to entries on the ARTG
• removal or continued inclusion of biologicals on the
ARTG
• any other matters concerning a biological, or other
matters referred to the ACB by the Minister or Secretary
Biologicals
39
The Advisory Committee on Biologicals
The Therapeutic Goods Regulations (1990) (TG Regulations) provide
for the ACB to have up to 12 members, with expertise in a range of
fields, including infectious diseases, cellular therapies and tissue
engineering, organ, tissue and stem cell transplantation, blood
products, clinical expertise, epidemiology and biostatistics, toxicology,
and consumer issues
The ACB can provide advice on issues other than biologicals, if
necessary, and all recommendations must be published
Biologicals
40
The Gene Technology Regulator
When a biological proposed for inclusion on the ARTG is,
or contains, a genetically modified (GM) product or a GM
organism, the TGA must notify the Office of the Gene
Technology Regulator (OGTR) and request advice about
the application
The OGTR may give written advice to the TGA, and the
TGA must ensure that this advice is taken into account
when making a decision about whether the product will be
included on the ARTG
Biologicals
41
Approach for ARTG listing – Decision phase
At the Decision phase:
• ACB or OGTR (or both) review and advise the TGA if requested
• Decision by the TGA
• Finalise conditions of registration
• Advise applicant
• Invoice final 25% of evaluation fee
Biologicals
42
What else?
Exemptions to allow for the use of Biologicals not currently
registered for clinical trials in exceptional circumstances
(eg: non-compliant product required immediately to treat a
life threatening condition)
A system for post-market monitoring and reporting adverse
events similar to those for Medicines and Medical Devices
Biological specific criminal penalties
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
Session 3 Agenda
Regulatory
43
Medical devices and diagnostics
44
Definition
Any instrument, apparatus, appliance, material or other
article (whether used alone or in combination, and including
the software necessary for its proper application) intended,
by the person under whose name it is or is to be supplied, to
be used for human beings for the purpose of one or more of
the following:
• diagnosis, prevention, monitoring, treatment or alleviation
of disease
• diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or disability
Therapeutic Goods Act 1989 (Cth) section 41BD
Medical devices and diagnostics
45
Definition
• investigation, replacement or modification of the anatomy
or of a physiological process
• control of conception
• and that does not achieve its principal intended action in or
on the human body by pharmacological, immunological or
metabolic means, but that may be assisted in its function
by such means
Therapeutic Goods Act 1989 (Cth) section 41BD
Medical devices and diagnostics
46
Examples
• artificial hips
• blood pressure monitors, blood glucose monitors, etc
• breast implants
• catheters
• condoms
• CT machines
• lubricating eyedrops
• orthodontics (eg: braces, fillings, dental implants)
• software tools that fit the definition in s41BD
• syringes
• tongue depressors
Medical devices and diagnostics
47
Examples
Not regulated by the ARGMD:
• tampons¹
• surface disinfectants¹
• devices incorporating human materials¹
In vitro diagnostics are also regulated differently to other medical
devices
¹ See: Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (v 4)
Medical devices and diagnostics
48
Medical devices must be listed on the ARTG
Before a medical device or diagnostic test can be marketed
in, imported to, or exported from Australia it must be listed
on the Australian Register of Therapeutic Goods (ARTG)
by the TGA
Applications which require expert advice are referred to
one or more of three committees
Medical devices and diagnostics
49
Medical device advisory committees
Committee Function
Advisory Committee
on Medical Devices
(ACMD)
Provides independent medical and scientific advice to the Minister and
the TGA on the safety, quality and performance of medical devices
supplied in Australia, including issues relating to pre-market conformity
assessment and post-market monitoring
Therapeutic Goods
Committee (TGC)
Advises the Minister on the adoption of standards for therapeutic goods
for human use, matters relating to standards including labelling and
packaging, and the principles to be observed in the manufacture of
therapeutic goods for human use
National Coordinating
Committee on
Therapeutic Goods
(NCCTG)
Consists of representatives from the states, territories, and the Australian
Government. The committee discusses many aspects of the regulation of
therapeutic goods
Medical devices and diagnostics
50
Regulatory framework and formal guidance
Therapeutic Goods Act 1989
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Orders (TGOs)
Excluded Goods Orders
Medical Device Standards Orders (MDSOs)
Conformity Assessment Standards Orders (CASOs)
The Australian Regulatory Guidelines for Medical Devices
(ARGMDs)
50 http://www.tga.gov.au/industry/legislation.htm
Medical devices and diagnostics
51
Regulatory framework and formal guidance
The legislation also makes provision for specific types of
devices, including:
• single-use devices
• active medical devices (energy using)
• medical devices that contain:
– medicines
– materials of animal, microbial, or recombinant origin
• systems or procedure packs
• medical devices for export only
• custom-made medical devices
Medical devices and diagnostics
52
Regulatory framework and formal guidance
IVDs have their own provisions
Some items that are therapeutic and not medical devices
are regulated under the Australian Medical Device
Requirements Under the Therapeutic Goods Act 1989
(version 4) which covers
• tampons
• surface disinfectants
• devices incorporating human materials
Medical devices and diagnostics
53
Regulatory framework
• The legislative framework adopts the philosophies of the
Global Harmonization Task Force (GHTF)
• As with therapeutics and biologics, risk based
classification applies dependent on intended use,
probability and severity of harm to patients, users and
others, degree of invasiveness in the human body,
duration of use and other risk factors
Medical devices and diagnostics
54
Classes
Higher
risk
Lower
risk
Medical device classification Example
Class 1 • Urine collection bottle
• Class Is (intended to be
supplied sterile)
• Class Im (with measuring
function)
• Sterile adhesive dressing strips
• Clinical thermometer
• Class IIa
• Class IIb
• X ray film
• Blood bags
• Class III
• AIMD (active implantable
medical device)
• Biological heart valves
• Implantable pacemakers
Medical devices and diagnostics
55
Classes
Higher
risk
Lower
risk
IVD classification Example
Class 1 IVD or Class 1 in-house
IVD: no public health risk or low
personal risk
• Glucose meter
Class 2 IVD or Class 2 in-house
IVD: low public health risk or
moderate personal risk
• Pregnancy and fertility self-testing
kits
Class 3 IVD or Class 3 in-house
IVD: moderate public health risk
or high personal risk
• Viral load and genotyping assays for
HIV and Hepatitis C
Class 4 IVD or Class 4 in-house
IVD: high risk
• Blood testing
Medical devices and diagnostics
56
Registration procedure
The medical device registration procedure involves
a Conformity Assessment and compliance with
the Essential Principles and other key
elements
Medical devices and diagnostics
57
Conformity Assessment
• The Conformity Assessment procedures are more
rigorous the higher the risk class
• Devices are monitored at all stages of the product
lifecycle and may be selected for review at any point
• Evidence for ongoing Conformity Assessment obligations
must be generated through the manufacturing process
and supply phase
• On obsolescence, the TGA must be notified so that the
product can be removed from the ARTG
Medical devices and diagnostics
58
Essential Principles
• From concept and prototype stage, the Essential
Principles must be incorporated into the design
• It is the manufacturer’s responsibility to demonstrate
compliance with the Essential Principles for their medical
devices
• There are six general Essential Principles that apply to all
devices and a further nine Essential Principles about
design and construction that apply to devices on a case-
by-case basis
• These are detailed in the seminar “Medical Devices and
Diagnostics” presentation deck
Medical devices and diagnostics
59
Other key elements
• the most common way to demonstrate compliance with
the Essential Principles is taking up the option to meet a
standard published by an Australian or International
Standards Agency, a Pharmacopoeia, or a similar
standard
• ongoing monitoring
• regulatory controls for manufacturing
• the ARTG listing as the central point of control
• potential penalties for breaches
• a range of corrective actions that may be taken if there is
a problem with a medical device
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
Session 3 Agenda
Regulatory
60
Agriculture and aquaculture
61
The elements of agriculture and aquaculture regulation
• Regional planning in line with appropriate planning and
land use principles
• Zoning areas considered appropriate for the development
of agriculture and aquaculture providing greater levels of
certainty for industry, government and community
• Transparent and equitable allocation of resources (eg:
marine and freshwater for aquaculture)
• Leasing – the right of occupation of public water/land and
long term tenure to encourage investment (eg: registered
leases)
Agriculture and aquaculture
62
The elements of agriculture and aquaculture regulation
• Risk assessment and management strategies
commensurate to the level of risk
• Development consent processes
• Licensing - authorising the activity and conditions of
operation (eg: GM authorisations)
• Compliance
• Environmental Management Systems and eco-efficiency
dd
Agriculture and aquaculture
63
GMOs must be licensed or listed on the GT Register
The legislation embodies a system of, and process for,
prohibitions and approvals of all dealings with live and
viable organisms that have been modified by gene
technology (for example: research, manufacture,
production, transport, destruction, commercial release or
import)
Includes the progeny (or descendants) of GMOs which also
share a genetically modified trait
Agriculture and aquaculture
64
GMOs must be licensed or listed on the GT Register
Every dealing with a GMO needs to be licensed by the GT
Regulator, unless the dealing is an exempt dealing, a
Notifiable Low Risk Dealing (NLRD), on the GMO Register
or specified in an Emergency Dealing Determination
(EDD).
Applications which require expert advice may be referred to
two committees
Agriculture and aquaculture
65
Advisory committees
Committee Function
Gene Technology
Technical Advisory
Committee (GTTAC)
Provides independent scientific and technical
advice on applications
Gene Technology
Ethics & Community
Consultative
Committee (GTECCC)
Advises the Minister on ethical issues and on
matters of general concern to the community
in relation to GE materials and products
Agriculture and aquaculture
66
Regulatory framework and formal guidance - Cth
Agricultural and Veterinary Chemicals Administration Act
1992 (Cth)
Agricultural and Veterinary Chemicals Code Act 1994 (Cth)
Australia New Zealand Food Standards Code
Control of Genetically Modified Crops Act 2004 (Vic)
Export Control Act 1982 (Cth)
Gene Technology Act 2000 (Cth)
Imported Food Control Act 1992 (Cth)
Quarantine Act 1908 (Cth)
Agriculture and aquaculture
67
Regulatory framework and formal guidance - Vic
Control of Genetically Modified Crops Act 2004
Gene Technology Act 2001
• No GM crop moratorium
• Commercial cultivation of GM canola since 2008
Agriculture and aquaculture
68
Regulatory framework and formal guidance - Tas
Gene Technology (Tasmania) Act 2012
Genetically Modified Organisms Control Act 2004
• Moratorium on commercial cultivation of all GM crops
• Whole of state designated GM free area
Agriculture and aquaculture
69
Regulatory framework and formal guidance – S.A.
Gene Technology Act 2001
Genetically Modified Crops Management Act 2004
• Moratorium on commercial cultivation and transport of
GM food crops and/or seed
• Whole of state designated GM free area
• Exemptions granted for field trials under specific
conditions
Agriculture and aquaculture
70
Regulatory framework and formal guidance – W.A.
Gene Technology Act 2006
Genetically Modified Crop Free Areas Act 2003
• Moratorium on commercial cultivation of all GM crops
• Whole of state designated GM free area
• Exemptions for commercial production of approved GM
cotton since 2008 and GM canola since 2010
Agriculture and aquaculture
71
Regulatory framework and formal guidance – N.T.
Gene Technology Act 2004
• No GM crop moratorium
• No commercial cultivation of GM crops
Agriculture and aquaculture
72
Regulatory framework and formal guidance – Qld
Gene Technology Act 2001
• No GM crop moratorium
• Large-scale commercial cultivation of GM cotton
Agriculture and aquaculture
73
Regulatory framework and formal guidance – N.S.W
Gene Technology (GM Crop Moratorium) Act 2003
Gene Technology (New South Wales) Act 2003
• Moratorium on commercial cultivation of GM food crops
• GM cotton exempt from moratorium and commercially
cultivated
• Exemption for commercial cultivation
• Prescription medicine regulation
• Biologicals
• Medical devices and diagnostics
• Agriculture and aquaculture
• Industrial applications and cleantech
Session 3 Agenda
Regulatory
74
Industrial Biotechnology: The application of molecular biology
technology to modify the biological function of an organism to
generate industrial products and processes
• biomass-based materials such as fuels and chemicals, and
• the treatment of waste water and producing energy using more
efficient measures
Cleantech: includes recycling, renewable energy (wind power, solar
power, biomass and hydropower, biofuels), information technology,
green transportation, electric motors, green chemistry, lighting, and
many other appliances that are now more energy efficient. It is a
means to create electricity and fuels with a smaller environmental
footprint and minimise pollution
Industrial Applications and Cleantech
75
Basic Overview of Industrial Applications and Cleantech
Industrial applications and cleantech
76
Eligible renewable energy sources
• hydro
• wave
• tide
• ocean
• wind
• solar
• geothermal-aquifer
• hot dry rock
• energy crops
• wood waste
• agricultural waste
• waste from processing of
agricultural products
• food waste
Renewable Energy (Electricity) Act 2000 (Cth) section 17
Industrial applications and cleantech
77
Eligible renewable energy sources
• food processing waste
• bagasse
• black liquor
• biomass-based components
of municipal solid waste
• landfill gas
• sewage gas and
biomass-based components
of sewage
• any other energy source
prescribed by the reg’s
Renewable Energy (Electricity) Act 2000 (Cth) section 17
Industrial applications and cleantech
78
Regulatory framework and formal guidance
Renewable Energy (Electricity) Act 2000
Renewable Energy (Electricity) (Large-scale Generation
Shortfall Charge) Act 2000
Renewable Energy (Electricity) (Small-scale Technology
Shortfall Charge) Act 2010
Renewable Energy (Electricity) Regulations 2001
http://ret.cleanenergyregulator.gov.au/About-the-Schemes/Legislation-and-regulations
Industrial applications and cleantech
79
Regulatory framework and formal guidance
Renewable Energy (Electricity) Amendment (Transitional
Provision) Regulations 2010
Renewable Energy (Electricity) Amendment (Transitional
Provisions) Regulations 2009
Renewable Energy (Electricity) Regulations 2001 - STC
Calculation Methodology for Solar Water Heaters and Air
Source Heat Pump Water Heaters
http://ret.cleanenergyregulator.gov.au/About-the-Schemes/Legislation-and-regulations

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Nw biotech fundamentals day 1 session 3 regulatory

  • 1. Biotech Boot Camp Session 3 – Regulatory Presenter: Nick Weston Melbourne, Brisbane, Sydney 28 May – 18 June, 2014
  • 2. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech 2 Session 3 Agenda Regulatory
  • 3. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech 3 Session 3 Agenda Regulatory
  • 4. • Prescription medicine regulation • prescription medicines • over the counter medicines • complementary medicines • blood, blood components and plasma derivatives • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech Session 3 Agenda Regulatory 4
  • 5. Prescription medicine regulation 5 Examples • Vaccines • Antibiotics • Antivenines • Immunoglobulins • MaBs • Anticoagulants • Hormones (eg: insulin, HGH) • Enzymes (eg: pancreatin) • Blood products
  • 6. Prescription medicine regulation 6 Background The Therapeutic Goods Administration (TGA) administers the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Regulations 1993 (Cth) The mission statement of the TGA ‘To ensure the safety, quality and efficacy of therapeutic goods available in Australia at a standard equal to that of comparable countries, and that pre-market assessment of therapeutic goods is conducted within a reasonable time.”
  • 7. Prescription medicine regulation 7 Background The TGA is accountable for the quality, safety, efficacy and timely availability of drugs and medical devices in Australia Performance targets for TGA drug evaluation and approval were set and are included in the Regulations The TGA operates on a 100% cost recovery basis
  • 8. Prescription medicine regulation 8 Background Before a drug (prescription or non-prescription), medical device, vitamin, nutritional, ‘TCM’, ‘alternative medicine’ or herbal product can be marketed in, imported to, or exported from Australia it must be listed on the Australian Register of Therapeutic Goods (ARTG) by the TGA New chemical entities and applications which require expert advice are referred to the Advisory Committee on Prescription Medicines (ACPM) for its non-binding recommendations
  • 9. Prescription medicine regulation 9 Background The TGA’s accountability includes an acceptance of a balance between safety and efficacy There is no such thing as a totally safe drug, and the approval process has regard to a risk / benefit ratio This requires a detailed evaluation of the data supplied by the company sponsoring an application for the listing of a particular drug
  • 10. Prescription medicine regulation 10 Approach for ARTG listing – 8 phases Generally, since 2010 all drug applications have to go through an eight stage process involving: • A ‘pre-submission’ of application planning phase • Submission phase • First round assessment • Section 31 response period • Second round assessment • Expert advisory review • Decision phase • Post-decision phase
  • 11. Prescription medicine regulation 11 Approach for ARTG listing – Pre-submission phase At the Pre-submission planning phase: • The applicants provide the TGA (before the 1st of a month) with planning data in the Pre-submission planning form (PPF) at least 2¼ months prior to lodgement of the Submission • dossier must include general submission information as well as information about the proposed application type and details of the quality, nonclinical and clinical evidence that will be provided in the dossier
  • 12. Prescription medicine regulation 12 Approach for ARTG listing – Pre-submission phase At the Pre-submission planning phase: • If the TGA considers a PPF complete and acceptable, the applicant will receive a Planning letter that provides • key dates for the phases and milestones of the regulatory process for the application • feedback from the TGA on justifications or other aspects affecting the application • Any specific conditions affecting dossier lodgment
  • 13. Prescription medicine regulation 13 Approach for ARTG listing – Submission phase At the Submission phase: • The applicant must lodge (by the 7th or 14th of the month) a complete dossier to the TGA for evaluation, there being no opportunity to deliver new data after the submission date except as provided by the Act (eg new safety data) • TGA will then: • check to see the dossier complies with Australian guidelines • Provide a Notification letter advising whether the application has been accepted for evaluation or not • Invoice the Sponsor for 75% of the evaluation fee
  • 14. Prescription drug regulation 14 Approach for ARTG listing – First round assessment phase At the First-round assessment phase the TGA (or sometimes external evaluators) evaluate all dossier content, such as • pharmaceutical and chemical data • animal pharmacology and toxicology data • clinical data If required a consolidated s.31 request for information will be prepared in the final month of the phase and sent to the applicant on the date set out in the Planning letter
  • 15. Prescription drug regulation 15 Approach for ARTG listing – Consolidated s.31 request response phase What is a s.31 request? Under s.31 of the Act the TGA can request information or documents relating to: • the formulation of the goods • the composition of the goods • the design specifications of the goods • the quality of the goods • manufacture method or procedures
  • 16. Prescription medicine regulation 16 Approach for ARTG listing – Consolidated s.31 request response phase What is a s.31 request? • the presentation of the goods • the safety and efficacy of the goods for the purposes for which they are to be used • whether the goods comply with conditions (if any) on the registration of the goods • the conformity of the goods to an applicable standard
  • 17. Prescription medicine regulation 17 Approach for ARTG listing – Consolidated s.31 request response phase What is a s.31 request? • whether either of the following has not been complied with: • an applicable provision of the Therapeutic Goods Advertising Code; • any other requirement relating to advertising • whether the goods are being supplied in imported into or exported from Australia • the regulatory history of the goods in another country • any other matter prescribed by the regulations for the purposes of s.31 in relation to goods of that kind
  • 18. Prescription medicine regulation 18 Approach for ARTG listing – Consolidated s.31 request response phase The s.31 request response period closes at the end of this phase • Applicants nominate whether they will respond to the s.31 request within 30 or 60 days as confirmed in the Planning letter • If the applicant does not respond by the date in the Planning letter, TGA evaluators complete the evaluation based on the initial dossier • The TGA evaluators conduct unit reviews and prepare/coordinate reports then prepare the first round assessment • The Applicant has an opportunity to review the first round assessment reports for factual correctness
  • 19. Prescription medicine regulation 19 Approach for ARTG listing – Second round assessment phase At the Second round assessment phase the TGA • Evaluators consider the s.31 response (if any) and finalise the evaluation reports • Where outstanding issues are identified they will be included in the evaluation reports for consideration by the TGA’s delegate • holds pre- ACPM consultations with the applicant • prepares approved product information (PI) and considers consumer product information (CPI) and a risk management plan (RMP) • Sends to the applicant the outcome of the assessments
  • 20. Prescription medicine regulation 20 Approach for ARTG listing – Expert advisory review TGA will then submit the final package of summaries and recommendations to the Advisory Committee on Prescription Medicines (ACPM) [formerly Australian Drug Evaluation Committee (ADEC)] (which meets 6 times/year) The ACPM committee is a group of doctors appointed by the Minister to advise on the suitability of drugs for marketing in Australia TGA takes into consideration the advice received from the ACPM when making a final recommendation
  • 21. Prescription medicine regulation 21 Approach for ARTG listing – Expert advisory review Typically, the ACPM committee will review and advise on only NCEs, new routes of administration, new fixed combinations, new therapeutic indications or changes in patient groups Applications not typically referred to the ACPM include generic products, new formulations, new strengths or reformulations of existing products unless the TGA has recommended a rejection of the application or when there are complex clinical issues
  • 22. Prescription medicine regulation 22 Approach for ARTG listing – Expert advisory review The delegate prepares a letter to ACPM if independent advice on aspects of an application is sought Applicants have an opportunity to • prepare a pre-ACPM response addressing issues raised in the delegates letter to ACPM • review the second round assessment reports for factual content The ACPM non-binding advice is finalised and sent to the applicant by the 15th of the month of the meeting
  • 23. Prescription medicine regulation 23 Approach for ARTG listing – Decision phase At the Decision phase the TGA: • makes a final decision • negotiates and finalises conditions of registration • advises the applicant • sends an invoice for the final 25% of evaluation fee • advises drug information centres, forensic laboratories, and so on if an NCE is involved If the delegate proposes to reject an application the reasons for decision are included in the letter of decision, with an explanation of appeal rights
  • 24. Prescription drug regulation 24 Approach for ARTG listing – Decision phase There are three main avenues of appeal: • the decision can be reviewed under s.60 of the Act by the Minister (or one of the Minister’s delegates within the Department) • an application to the Administrative Appeals Tribunal (AAT) for administrative review may be made within 28 calendar days of the Minister’s decision regarding a section 60 appeal • An application to the Federal Court of Australia on legal grounds may be brought at any time
  • 25. Prescription drug regulation 25 Approach for ARTG listing – Registration At the Post-decision (formerly called Registration) phase • the Sponsor applies to register (or vary) the product on the ARTG • TGA allocates an ‘AustR number’ • where applicable TGA will prepare a draft Australian Public Assessment Report for prescription medicines (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not • supply is then permitted
  • 26. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture • Aquaculture Session 3 Agenda Regulatory 26
  • 27. • Prescription medicine regulation • Biologicals • tissue based products (skin and bone) • human stem cells • cell-based products • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech Session 3 Agenda Regulatory 27
  • 28. Biologicals 28 Definition A good that comprises, contains or is derived from human cells or human tissues and is used to: • treat or prevent disease • diagnose the condition of a person • influence, inhibit or modify a physiological process in a person • test the susceptibility of a person to a disease or ailment • replace or modify parts in the anatomy of a person
  • 29. Biologicals 29 Examples • Tissue based products (eg: bone, skin, collagen, ocular, CV) • Cell based products (eg: human stem cells, T cells, cartilage cells) • Combined cell and tissue products (eg: collagen matrices for local delivery, metal stent coated with a matrix and endothelial cells) Not regulated by the TGA: • Fresh viable organs • IVF • Fresh haematopoietic progenitor cells (eg: bone marrow transplants) • Autologous undifferentiated cells and tissues made by a medical practitioner used to perform the same basic function
  • 30. Biologicals 30 Background Before a biological can be marketed in, imported to, or exported from Australia it must be listed on the Australian Register of Therapeutic Goods (ARTG) by the TGA Applications which require expert advice are referred to the Advisory Committee on Biologicals (ACB) for its non- binding recommendations
  • 31. Biologicals 31 Regulatory framework and formal guidance Therapeutic Goods Act 1989 Therapeutic Goods Regulations 1990 Therapeutic Goods (Charges) Regulations 1990 Therapeutic Goods (Things that are not biologicals) Determination No. 1 of 2011 Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 Therapeutic Goods Orders (product standards for biologicals) The Australian Regulatory Guidelines for Biologicals 31 http://www.tga.gov.au/industry/legislation.htm
  • 32. Biologicals 32 Classes Higher risk Lower risk Biological classification Example • Class 1: If declared in s.16 of TG Regs • None yet • Class 2: simple preparation for like- for-like biological repairs • Milled bone for allograft • Acellular skin for wound covering • Class 3: more complex preparation for but does not change an inherent biological property • Mesenchymal stem cells for graft v host disease • Demineralised cadaveric bone mixed with antibiotic carrier • Cultured fibroblasts for skin repair • Class 4: complex and changes biological properties • GM T cells for specific virus infections • Dermal fibroblasts transformed for skeletal muscle repair • Bone marrow stem cells for cardiac repair
  • 33. Biologicals 33 Approach for ARTG listing – summary of phases Generally, once the TGA has prepared the relevant standards and guidelines, all biological applications have to go through a four stage process involving: • Preparation and lodgement of dossier • Evaluation (with expert advisory review by ACB if required) • Decision phase • Finalisation
  • 34. Biologicals 34 Approach for ARTG listing – Preparation of dossier and lodgment phase At the Preparation and dossier lodgment phase: • The biological may first come to the attention of the TGA when an application for marketing is received or when an Australian clinical trial is being planned • For clinical trials, the applicant may submit preliminary data for evaluation to the TGA (CTX scheme) or notify the TGA (CTN scheme) that the trial has been approved by an institutional ethics committee • The dossier needs to evidence the method of manufacture and method of use so that a risk assessment can be performed
  • 35. Biologicals 35 Approach for ARTG listing – Evaluation phase At the Evaluation phase: • The dossier submission is evaluated based on the evidence it contains to ensure compliance with any default standards (such as pharmacopoeial monographs), product-specific standards (eg: TGO 83 – Standards for human musculoskeletal tissue) or some requirements of TGO 86 (Standards for human skin) may apply and TGO 87 (labelling) • Labelling for example is vital for quality data to allow donor traceability, evidence of donor selection, validation of testing for viruses, control of manufacturing and transportation, stability and traceable bio-burden (microbial growth) testing
  • 36. Biologicals 36 Approach for ARTG listing – Evaluation phase At the Evaluation phase: • Compliance with all other dossier requirements for a biological in its relevant class is assessed, including sections on nonclinical and clinical development • Nonclinical data will be evaluated by toxicologists for biological dynamics and kinetics, lab data re efficacy, tox data and tumorgenicity • Clinical data is typically reviewed by a physician • The level of detail in the dossier should correspond to the potential risk that the product poses to the recipient
  • 37. Biologicals 37 Approach for ARTG listing – Evaluation phase At the Evaluation phase: • Like medicines, biologicals are required to be manufactured according to Good Manufacturing Practice (GMP) • Compliance with manufacturing principles is required, including the Australian Code of GMP for human blood and tissues • All manufacturers are inspected to ensure GMP-compliance • This is demonstrated by a current TGA manufacturing licence or clearance
  • 38. Biologicals 38 The Advisory Committee on Biologicals The Advisory Committee on Biologicals (ACB) advises and makes recommendations to the TGA (formally, to the Health Minister or the Secretary of the health department) on: • which biologicals can be included on the ARTG • variations to entries on the ARTG • removal or continued inclusion of biologicals on the ARTG • any other matters concerning a biological, or other matters referred to the ACB by the Minister or Secretary
  • 39. Biologicals 39 The Advisory Committee on Biologicals The Therapeutic Goods Regulations (1990) (TG Regulations) provide for the ACB to have up to 12 members, with expertise in a range of fields, including infectious diseases, cellular therapies and tissue engineering, organ, tissue and stem cell transplantation, blood products, clinical expertise, epidemiology and biostatistics, toxicology, and consumer issues The ACB can provide advice on issues other than biologicals, if necessary, and all recommendations must be published
  • 40. Biologicals 40 The Gene Technology Regulator When a biological proposed for inclusion on the ARTG is, or contains, a genetically modified (GM) product or a GM organism, the TGA must notify the Office of the Gene Technology Regulator (OGTR) and request advice about the application The OGTR may give written advice to the TGA, and the TGA must ensure that this advice is taken into account when making a decision about whether the product will be included on the ARTG
  • 41. Biologicals 41 Approach for ARTG listing – Decision phase At the Decision phase: • ACB or OGTR (or both) review and advise the TGA if requested • Decision by the TGA • Finalise conditions of registration • Advise applicant • Invoice final 25% of evaluation fee
  • 42. Biologicals 42 What else? Exemptions to allow for the use of Biologicals not currently registered for clinical trials in exceptional circumstances (eg: non-compliant product required immediately to treat a life threatening condition) A system for post-market monitoring and reporting adverse events similar to those for Medicines and Medical Devices Biological specific criminal penalties
  • 43. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech Session 3 Agenda Regulatory 43
  • 44. Medical devices and diagnostics 44 Definition Any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: • diagnosis, prevention, monitoring, treatment or alleviation of disease • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability Therapeutic Goods Act 1989 (Cth) section 41BD
  • 45. Medical devices and diagnostics 45 Definition • investigation, replacement or modification of the anatomy or of a physiological process • control of conception • and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means Therapeutic Goods Act 1989 (Cth) section 41BD
  • 46. Medical devices and diagnostics 46 Examples • artificial hips • blood pressure monitors, blood glucose monitors, etc • breast implants • catheters • condoms • CT machines • lubricating eyedrops • orthodontics (eg: braces, fillings, dental implants) • software tools that fit the definition in s41BD • syringes • tongue depressors
  • 47. Medical devices and diagnostics 47 Examples Not regulated by the ARGMD: • tampons¹ • surface disinfectants¹ • devices incorporating human materials¹ In vitro diagnostics are also regulated differently to other medical devices ¹ See: Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (v 4)
  • 48. Medical devices and diagnostics 48 Medical devices must be listed on the ARTG Before a medical device or diagnostic test can be marketed in, imported to, or exported from Australia it must be listed on the Australian Register of Therapeutic Goods (ARTG) by the TGA Applications which require expert advice are referred to one or more of three committees
  • 49. Medical devices and diagnostics 49 Medical device advisory committees Committee Function Advisory Committee on Medical Devices (ACMD) Provides independent medical and scientific advice to the Minister and the TGA on the safety, quality and performance of medical devices supplied in Australia, including issues relating to pre-market conformity assessment and post-market monitoring Therapeutic Goods Committee (TGC) Advises the Minister on the adoption of standards for therapeutic goods for human use, matters relating to standards including labelling and packaging, and the principles to be observed in the manufacture of therapeutic goods for human use National Coordinating Committee on Therapeutic Goods (NCCTG) Consists of representatives from the states, territories, and the Australian Government. The committee discusses many aspects of the regulation of therapeutic goods
  • 50. Medical devices and diagnostics 50 Regulatory framework and formal guidance Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices) Regulations 2002 Therapeutic Goods Orders (TGOs) Excluded Goods Orders Medical Device Standards Orders (MDSOs) Conformity Assessment Standards Orders (CASOs) The Australian Regulatory Guidelines for Medical Devices (ARGMDs) 50 http://www.tga.gov.au/industry/legislation.htm
  • 51. Medical devices and diagnostics 51 Regulatory framework and formal guidance The legislation also makes provision for specific types of devices, including: • single-use devices • active medical devices (energy using) • medical devices that contain: – medicines – materials of animal, microbial, or recombinant origin • systems or procedure packs • medical devices for export only • custom-made medical devices
  • 52. Medical devices and diagnostics 52 Regulatory framework and formal guidance IVDs have their own provisions Some items that are therapeutic and not medical devices are regulated under the Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4) which covers • tampons • surface disinfectants • devices incorporating human materials
  • 53. Medical devices and diagnostics 53 Regulatory framework • The legislative framework adopts the philosophies of the Global Harmonization Task Force (GHTF) • As with therapeutics and biologics, risk based classification applies dependent on intended use, probability and severity of harm to patients, users and others, degree of invasiveness in the human body, duration of use and other risk factors
  • 54. Medical devices and diagnostics 54 Classes Higher risk Lower risk Medical device classification Example Class 1 • Urine collection bottle • Class Is (intended to be supplied sterile) • Class Im (with measuring function) • Sterile adhesive dressing strips • Clinical thermometer • Class IIa • Class IIb • X ray film • Blood bags • Class III • AIMD (active implantable medical device) • Biological heart valves • Implantable pacemakers
  • 55. Medical devices and diagnostics 55 Classes Higher risk Lower risk IVD classification Example Class 1 IVD or Class 1 in-house IVD: no public health risk or low personal risk • Glucose meter Class 2 IVD or Class 2 in-house IVD: low public health risk or moderate personal risk • Pregnancy and fertility self-testing kits Class 3 IVD or Class 3 in-house IVD: moderate public health risk or high personal risk • Viral load and genotyping assays for HIV and Hepatitis C Class 4 IVD or Class 4 in-house IVD: high risk • Blood testing
  • 56. Medical devices and diagnostics 56 Registration procedure The medical device registration procedure involves a Conformity Assessment and compliance with the Essential Principles and other key elements
  • 57. Medical devices and diagnostics 57 Conformity Assessment • The Conformity Assessment procedures are more rigorous the higher the risk class • Devices are monitored at all stages of the product lifecycle and may be selected for review at any point • Evidence for ongoing Conformity Assessment obligations must be generated through the manufacturing process and supply phase • On obsolescence, the TGA must be notified so that the product can be removed from the ARTG
  • 58. Medical devices and diagnostics 58 Essential Principles • From concept and prototype stage, the Essential Principles must be incorporated into the design • It is the manufacturer’s responsibility to demonstrate compliance with the Essential Principles for their medical devices • There are six general Essential Principles that apply to all devices and a further nine Essential Principles about design and construction that apply to devices on a case- by-case basis • These are detailed in the seminar “Medical Devices and Diagnostics” presentation deck
  • 59. Medical devices and diagnostics 59 Other key elements • the most common way to demonstrate compliance with the Essential Principles is taking up the option to meet a standard published by an Australian or International Standards Agency, a Pharmacopoeia, or a similar standard • ongoing monitoring • regulatory controls for manufacturing • the ARTG listing as the central point of control • potential penalties for breaches • a range of corrective actions that may be taken if there is a problem with a medical device
  • 60. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech Session 3 Agenda Regulatory 60
  • 61. Agriculture and aquaculture 61 The elements of agriculture and aquaculture regulation • Regional planning in line with appropriate planning and land use principles • Zoning areas considered appropriate for the development of agriculture and aquaculture providing greater levels of certainty for industry, government and community • Transparent and equitable allocation of resources (eg: marine and freshwater for aquaculture) • Leasing – the right of occupation of public water/land and long term tenure to encourage investment (eg: registered leases)
  • 62. Agriculture and aquaculture 62 The elements of agriculture and aquaculture regulation • Risk assessment and management strategies commensurate to the level of risk • Development consent processes • Licensing - authorising the activity and conditions of operation (eg: GM authorisations) • Compliance • Environmental Management Systems and eco-efficiency dd
  • 63. Agriculture and aquaculture 63 GMOs must be licensed or listed on the GT Register The legislation embodies a system of, and process for, prohibitions and approvals of all dealings with live and viable organisms that have been modified by gene technology (for example: research, manufacture, production, transport, destruction, commercial release or import) Includes the progeny (or descendants) of GMOs which also share a genetically modified trait
  • 64. Agriculture and aquaculture 64 GMOs must be licensed or listed on the GT Register Every dealing with a GMO needs to be licensed by the GT Regulator, unless the dealing is an exempt dealing, a Notifiable Low Risk Dealing (NLRD), on the GMO Register or specified in an Emergency Dealing Determination (EDD). Applications which require expert advice may be referred to two committees
  • 65. Agriculture and aquaculture 65 Advisory committees Committee Function Gene Technology Technical Advisory Committee (GTTAC) Provides independent scientific and technical advice on applications Gene Technology Ethics & Community Consultative Committee (GTECCC) Advises the Minister on ethical issues and on matters of general concern to the community in relation to GE materials and products
  • 66. Agriculture and aquaculture 66 Regulatory framework and formal guidance - Cth Agricultural and Veterinary Chemicals Administration Act 1992 (Cth) Agricultural and Veterinary Chemicals Code Act 1994 (Cth) Australia New Zealand Food Standards Code Control of Genetically Modified Crops Act 2004 (Vic) Export Control Act 1982 (Cth) Gene Technology Act 2000 (Cth) Imported Food Control Act 1992 (Cth) Quarantine Act 1908 (Cth)
  • 67. Agriculture and aquaculture 67 Regulatory framework and formal guidance - Vic Control of Genetically Modified Crops Act 2004 Gene Technology Act 2001 • No GM crop moratorium • Commercial cultivation of GM canola since 2008
  • 68. Agriculture and aquaculture 68 Regulatory framework and formal guidance - Tas Gene Technology (Tasmania) Act 2012 Genetically Modified Organisms Control Act 2004 • Moratorium on commercial cultivation of all GM crops • Whole of state designated GM free area
  • 69. Agriculture and aquaculture 69 Regulatory framework and formal guidance – S.A. Gene Technology Act 2001 Genetically Modified Crops Management Act 2004 • Moratorium on commercial cultivation and transport of GM food crops and/or seed • Whole of state designated GM free area • Exemptions granted for field trials under specific conditions
  • 70. Agriculture and aquaculture 70 Regulatory framework and formal guidance – W.A. Gene Technology Act 2006 Genetically Modified Crop Free Areas Act 2003 • Moratorium on commercial cultivation of all GM crops • Whole of state designated GM free area • Exemptions for commercial production of approved GM cotton since 2008 and GM canola since 2010
  • 71. Agriculture and aquaculture 71 Regulatory framework and formal guidance – N.T. Gene Technology Act 2004 • No GM crop moratorium • No commercial cultivation of GM crops
  • 72. Agriculture and aquaculture 72 Regulatory framework and formal guidance – Qld Gene Technology Act 2001 • No GM crop moratorium • Large-scale commercial cultivation of GM cotton
  • 73. Agriculture and aquaculture 73 Regulatory framework and formal guidance – N.S.W Gene Technology (GM Crop Moratorium) Act 2003 Gene Technology (New South Wales) Act 2003 • Moratorium on commercial cultivation of GM food crops • GM cotton exempt from moratorium and commercially cultivated • Exemption for commercial cultivation
  • 74. • Prescription medicine regulation • Biologicals • Medical devices and diagnostics • Agriculture and aquaculture • Industrial applications and cleantech Session 3 Agenda Regulatory 74
  • 75. Industrial Biotechnology: The application of molecular biology technology to modify the biological function of an organism to generate industrial products and processes • biomass-based materials such as fuels and chemicals, and • the treatment of waste water and producing energy using more efficient measures Cleantech: includes recycling, renewable energy (wind power, solar power, biomass and hydropower, biofuels), information technology, green transportation, electric motors, green chemistry, lighting, and many other appliances that are now more energy efficient. It is a means to create electricity and fuels with a smaller environmental footprint and minimise pollution Industrial Applications and Cleantech 75 Basic Overview of Industrial Applications and Cleantech
  • 76. Industrial applications and cleantech 76 Eligible renewable energy sources • hydro • wave • tide • ocean • wind • solar • geothermal-aquifer • hot dry rock • energy crops • wood waste • agricultural waste • waste from processing of agricultural products • food waste Renewable Energy (Electricity) Act 2000 (Cth) section 17
  • 77. Industrial applications and cleantech 77 Eligible renewable energy sources • food processing waste • bagasse • black liquor • biomass-based components of municipal solid waste • landfill gas • sewage gas and biomass-based components of sewage • any other energy source prescribed by the reg’s Renewable Energy (Electricity) Act 2000 (Cth) section 17
  • 78. Industrial applications and cleantech 78 Regulatory framework and formal guidance Renewable Energy (Electricity) Act 2000 Renewable Energy (Electricity) (Large-scale Generation Shortfall Charge) Act 2000 Renewable Energy (Electricity) (Small-scale Technology Shortfall Charge) Act 2010 Renewable Energy (Electricity) Regulations 2001 http://ret.cleanenergyregulator.gov.au/About-the-Schemes/Legislation-and-regulations
  • 79. Industrial applications and cleantech 79 Regulatory framework and formal guidance Renewable Energy (Electricity) Amendment (Transitional Provision) Regulations 2010 Renewable Energy (Electricity) Amendment (Transitional Provisions) Regulations 2009 Renewable Energy (Electricity) Regulations 2001 - STC Calculation Methodology for Solar Water Heaters and Air Source Heat Pump Water Heaters http://ret.cleanenergyregulator.gov.au/About-the-Schemes/Legislation-and-regulations