This document summarizes John Skerritt's introductory remarks at an inaugural industry forum on good manufacturing practices (GMP). The key points discussed include: 1) Recent reforms to Australia's medicines and medical devices regulations that will impact GMP, including priority reviews, provisional approvals, and reforms for sunscreens and low-risk goods. 2) Initiatives to assist small and medium enterprises (SMEs) with GMP compliance like training, guidance documents, and signposting to other business support services. 3) Ongoing work to streamline GMP processes like risk-based inspections, international cooperation through programs like PIC/S, and greater reliance on inspections of other

1. Inaugural Industry Forum on Good
Manufacturing Practice
Introductory remarks
John Skerritt – 26 June 2018

2. This presentation
GMP is often seen as an “enabling function” but there was
overwhelming interest in this meeting!
• Medicine and Medical Devices Review implementation
• SME Assist
• Other reforms to inspections and clearances
• Medicinal cannabis products
• International cooperation in brief
1

3. Medicines and Medical Devices Regulation Review
• The most extensive changes to TGA regulation in a generation
• Legislative changes in place, most business changes implemented
• Many reforms affect demand for/ timeframes for GMP:
§ Priority review
§ Provisional approvals
§ Comparable Overseas regulator approvals
§ Low-risk therapeutic goods
§ Sunscreen reforms
2

4. SMEAssist
• Phone/ email support
• Training workshops
• SME-specific guidance documents
• Interactive decision trees
• Subscription services/ targeting
• Signposting to other services e.g.
international regulators, funding and business
support, facility access, reimbursement
3

5. Other reforms: progress
• Risk-based approach to inspection frequency, re-inspection
frequencies and different product types introduced for medicines
and blood, tissue and cellular therapies
• Increasing industry education and stakeholder engagement
• TGA-Industry technical working groups to finalise GMP
guidances
• Streamlining of internal business processes for GMP clearances
and compliance verification
4

6. Work in progress
• Sunscreens - aligning oversight to risk - PICS
interpretation, other inspection options,
ingredient requirements
• Joint inspections with other regulators
§ Unclear what the implications of publication of
inspections findings ands conditions e.g. by
Canada will be
• Fuller reliance on other countries for
clearances/ compliance verification
5

7. GMP fees and charges
• Changes to fees and charges for Australian and overseas
inspections from July 2018
• Lower fees for lower risk products/ more compliant manufacturers
• In order to reduce impact on industry, increases in GMP clearance
application / compliance verification fees will be implemented from
July 2019
• A fairer charging scheme - but we will under-recover actual costs
until July 2019
6

8. GMP application to medicinal cannabis APIs
Type of
manufacturing
The Code of GMP (Part II)
is applied to processes shown in bold
API extracted
(plant)
Collection of
plants
Cutting/initial
extraction(s)
Introduce the
API starting
material
Isolate and
purify
Process
and pack
Herbal extracts
(used as API)
Collection of
plants
Cutting/initial
extraction(s)
Further
extract
Process
and pack
API powdered
herbs
Collection of
plants and/or
cultivation and
harvesting
Cutting and
commuting
Process
and pack
7

9. “ if a system, service or product has been
approved under a trusted international standard
or risk assessment, then our regulators should not
impose any additional requirements for approval
in Australia, unless it can be demonstrated that
there is a good reason to do so”.
In Australia, international regulatory
cooperation is also official Government policy
Prime Minister’s media release 14 October 2014

10. International Coalition of Medicines
RegulatoryAuthorities
Policy dialogue at agency head level (23 countries, EMA, EU and WHO)
Initial projects completed:
• Generic medicines information sharing processes
• Documentation of capacity building initiatives
• Establishment of systems to support GMP Inspection reports from one
regulator to be recognised by other regulators – now PIC/S process
Projects underway
• Pharmacovigilance – big data, enhancing HCP reporting, vaccines
• Supply chain security and crisis management
• Innovation and horizon scanning – new regulatory pathways

11. • Common template and safety assessment of 10 complementary
medicine ingredients, starting cooperation on efficacy/claims
• First work sharing trial for a generic medicine completed, along with
convergence of technical requirements e.g. bioequivalence
• Work sharing on New Chemical Entity submissions underway,
biosimilars cooperation being considered
• Synchronising submissions by industry to different countries is hard
• Secure portal for confidential information exchange developed
Implementation of work sharing on evaluating
new medicines

12. Pharmaceutical Inspection
Convention/Co-operation Scheme
• Development and maintenance of harmonised
GMP standards and quality systems for
medicines inspectorates
• Use of GMP clearances based on reports
from recent inspection by other regulators
reduces the number of TGA overseas
inspections required by 90%
• Need to further develop process to see what
third country inspections we can recognise and
obtain GMP inspection plans

13. Conclusions
• Manufacturing quality is a central part of TGA’s regulatory system
• So impacts on GMP processes and demand need to be closely considered in
implementing reforms to medicines regulation
• Further business improvements underway
• International regulatory collaboration will provide benefits for
• industry – faster market access, lower costs
• earlier patient access to medicines
• regulators – reduced workload, less duplication
• Can make even greater use of inspections done by other regulators
(but Australia has to contribute to the global inspection effort!)
• Stronger communication and partnering with industry will be critical