DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
1. THERAPEUTIC GOODS ADMINISTRATIOn (TGA)
&
MEDICINES AND HEALTH CARE PRODUCTS
REGULATORY AGENCY (MHRA)
1
Guided By:
Dr. Gururaj S. Kulkarni
Department of Pharmaceutics
MALLIGE COLLEGE OF PHARMACY
Presented
By:
Manikant Prasad Shah
Mpharm II Sem.
2. List of contents:
2
Contents: TGA
What is TGA ?
Objective of TGA
Role of TGA
TGA structure
Committees
Australian register of therapeutic goods (ARTG)
The guidelines of TGA for
Listed Medicines
Registered Medicines
Complementary Medicines
OTC Medicine
Prescription Medicines
3. 3
Medical devices
Blood and Tissues
Chemicals
Exempt or excluded medicines
UK-MHRA
What is MHRA ?
Aims of MHRA
Objectives of MHRA
Activities of MHRA
Structure of MHRA
5. What is TGA?
5
The Therapeutic Goods Administration (TGA) is a
unit of the Australian Government Department of
Health and Ageing, is responsible for administering
the Act.
Which came into effect on 15 February 1991.
THERAPEUTIC GOODS ADMINISTRATION(TGA)
6. 6
Objective of TGA…
To provide a national framework for the regulation of
therapeutic goods in Australia to ensure the quality,
safety and efficacy of medicines and ensure the
quality, safety and performance of medical devices
Essentially therapeutic goods must be entered on
the Australian Register of Therapeutic Goods
(ARTG) before they can be supplied in Australia
7. Role of the TGA
7
The TGA carries out an overall control through five
main processes:
Pre-market evaluation and approval of registered
products intended for supply in Australia;
Development, maintenance and monitoring of the
systems for listing of medicines;
Licensing of manufacturers in accordance with
international standards of GMPs
8. 8
Post-market monitoring, through sampling, adverse
event reporting, surveillance activities, and response
to public inquiries;
The assessment of medicines for export.
9. TGA structure
9
The TGA's offices are grouped into three
core groups - Market Authorisation Group,
Monitoring and Compliance Group and
Regulatory Support Group
CHART
1. TGA Executive
2. Market Authorization Group (MAG )
3. Monitoring and Compliance Group (MCG)
4. Regulatory Support Group
5. Office of Regulatory Integrity(ORI)
10. 10
1. TGA Executive
The TGA Executive has overall responsibility for
the management of the TGA's regulatory
functions and activities.
The TGA Executive comprises:
TGA National Manager
Principal Medical Adviser,
Principal Legal Adviser,
Chief Regulatory Officer,
Chief Operating Officer
11. 2. Market Authorization Group (MAG)
11
The Market Authorization Group is responsible for
undertaking evaluations of applications to approve
new therapeutic products for supply in Australia. The
MAG makes decisions whether to approve or reject
market authorization of medicines, medical devices
and blood and tissues that are imported, exported,
manufactured and supplied in Australia.
12. 3. Monitoring and Compliance Group (MCG)
12
The Monitoring and Compliance Group is
responsible for ongoing monitoring of therapeutic
products approved for supply in Australia to ensure
they meet the necessary standards throughout their
lifecycle.
13. 4. Regulatory Support Group
13
Provides whole-of-agency regulatory support
services to the TGA, this includes the legal,
finance, information technology and information
management, communications, parliamentary
and human resource management services.
14. 5. Office of Regulatory Integrity(ORI)
14
The Office of Regulatory Integrity (ORI)
provides an independent and objective
review and advisory service to provide
assurance to the National Manager of the
TGA that the TGA's financial and
operational controls are operating in an
efficient, effective and appropriate manner
and that its regulatory controls are operating
in an efficient, effective and appropriate
manner and are consistent with relevant
legislative requirements.
15. Committees
15
The TGA is supported in its work by a number of external expert
advisory committees, including
Australian Drug Evaluation Committee (ADEC) - for
prescription medicines
Adverse Drug Reactions Advisory Committee (ADRAC)
Medicines Evaluation Committee(MEC) - for over-the-counter
medicines
16. 16
Complementary Medicines Evaluation
Committee(CMEC) - for complementary medicines
Therapeutic Devices Evaluation Committee
(TDEC) - for medical devices
National Drugs and Poisons Scheduling Committee
(NDPSC)
Therapeutic Goods Committee (TGC)
17. Australian register of therapeutic
goods (ARTG)
17
A 'therapeutic good' is broadly defined as a good
which is represented in any way to be taken, for
therapeutic use.
Therapeutic use means use in connection with
Preventing, diagnosing, curing a disease,
ailment, defect or injury;
Inhibiting or modifying a physiological process;
Testing for pregnancy;
Replacement or modification of parts of the
anatomy
18. 18
The Australian Register of Therapeutic Goods (ARTG)
was established under the Therapeutic Goods Act 1989.
The ARTG is a computer database of therapeutic
goods. Therapeutic goods are divided broadly into two
classes: medicines and medical devices.
Unless exempt, medicines must be entered as either
'registered' or 'listed' medicines and medical devices
must be included before they may be supplied in or
exported from Australia.
19. 19
AUST R medicines are assessed for safety,
quality and effectiveness and higher risk
medication.
They include all prescription medicines.
Many over-the-counter products such as those
for pain relief, coughs and colds and antiseptic
creams.
20. 20
AUST L medicines are much lower risk self-
medication products.
They are used for minor health problems and are
reviewed for safety and quality. They include
sunscreens and many vitamin, mineral, herbal and
homoeopathic products
Listed and Registered medicines are differentiated on
the product label by the designation, 'AUST L' or
'AUST R' respectively, followed by a unique number.
21. Assessment criteria
21
Whether a product is listed or registered in the
ARTG depends largely on three things:
The ingredients;
The dosage form of the product; and,
The promotional or therapeutic claims made for
the product.
22. 22
In assessing the level of 'risk', factors such as
strength of a product
side effects,
toxicity, and
the seriousness of the medical condition for which the
product is intended to be used.
23. Product Information (PI)
23
Product Information (PI) is a term used to describe the
technical information approved by the TGA and
intended for distribution to health professionals
Statement of ingredients
Directions for use and dosage
Warning statements and contraindications
Distinctiveness of labels
Graphics, logos and symbols
Reference to other products
Internet addresses
Foreign language text on labels
24. 24
The PI should contain information under the following
headings:
Name of the medicine
Description
Pharmacology
Clinical trials
Contraindications
Precautions
Adverse effects
Dosage and administration
Overdosage
Storage conditions
Name and address of the sponsor
Date of approval
25. Listed medicines
25
Listed medicines are considered to be of lower
risk than registered medicines. The majority of
listed medicines are self-selected by
consumers and used for self-treatment.
such as vitamin and mineral products or
sunscreens.
They do NOT contain substances that are
scheduled in the SUSDP(Standard for the
uniform Scheduling of Drugs and Poisons)
26. 26
Most complementary medicines (eg. herbal, vitamin
and mineral products) and sunscreens are examples of
listed products.
All listed medicines must display an "AUST L"
number on the label as proof of listing.
27. Registered medicines
27
Medicines assessed as having a higher level of risk
must be registered. The degree of assessment and
regulation they undergo is rigorous and detailed, with
sponsors being required to provide comprehensive
safety, quality and efficacy data.
All registered medicines……
Must display an AUST R number on the label as
proof of registration;
Are evaluated as either 'high risk' or 'low risk'
registered.
28. 28
Prescription medicines fit into the sub-
category of registered medicines as High-risk
Registered products.
This group includes all prescription medicines
and some specified products such as sterile
injectables.
29. Non-prescription (low risk) registered
29
Low-risk registered products are non-
prescription medicines. Products in this
category are considered to be lower risk
than prescription medicines. However, they
still require a high level of scrutiny, for
example to ensure adequate labelling for
appropriate use.
Examples of products in this category are
mild analgesics, cough/cold preparations,
anti-fungal creams.
30. Complementary medicines
24
TGA has developed the Australian Regulatory
Guidelines for Complementary Medicines
(ARGCM) to assist sponsors of complementary
medicines to meet their legislative requirement.
Complementary medicines are also known as
'alternative medicines',
'natural medicines'
‘traditional medicines’
Examples include vitamins, minerals, nutritional
supplements and herbal, aromatherapy and
homeopathic products.
31. Purpose of ARGCM
31
Provide information to help sponsors of
complementary medicines to meet their therapeutic
goods legislation;
Applications to the TGA relating to complementary
medicines processed successfully within minimum
timeframes;
Enhance clarity and transparency of processes leading
to the Registration and Listing of complementary
medicines in the Australian Register of Therapeutic
Goods (ARTG).
32. Over-The-Counter (OTC) Medicine
32
These are medicines which are available without
a prescription but not ‘complementary
medicines’.
The object of the guidelines is to assist sponsors
to submit applications which will be evaluated in
the minimum possible time and be successful.
33. 33
Where an evaluation of a product or substance via the
OTC route, the primary factors to be taken into
account include:
The safety of the active substance;
• The need for professional counseling before use;
• The nature of the ailments or symptoms to be treated
• The abuse potential of the product or substance;
• The incidence of adverse effects and
contraindications;
• The risk of masking serious disease;
• The risk/benefit profile of the product (eg. therapeutic
index).
34. The Act states that the presentation of OTC
medicine is unacceptable
34
if it is capable of being misleading or confusing as
to the content or proper use of the goods
if it suggests that the goods have ingredients,
components or characteristics that they do not
have;
if a name applied to the goods is the same as the
name applied to other therapeutic goods that are
supplied in Australia
if the label of the goods does not declare the
presence of a therapeutically active ingredient
35. Prescription Medicines
35
You need a doctor's prescription to buy these from a
pharmacist. Otherwise, only authorized health care
professionals can supply them, such as in a hospital
setting. Examples include contraceptive pills,
antibiotics and strong painkillers.
Condition of registration under the Therapeutic
Goods Act 1989 (the Act) that a PI be provided for
each registered product.
After registration, the PI must not be changed
without TGA approval
36. 36
Prescription Medicines Include a new medicine
in the ARTG that are evaluated by the Drug Safety
and Evaluation Branch (DSEB) of the TGA
37. 37
Medical devices:
Medical Devices Evaluation Committee (MDEC)
which provides advice to the Minister on issues
relating to the safety, quality, performance and timely
availability of medical devices
The regulation of medical devices includes the
following features:
classifying the medical device based on different
levels of risk
assessing compliance with a set of essential principles
for their quality, safety and performance
38. Examples of medical devices include:
implementing appropriate regulatory controls for
the manufacturing processes of medical devices
including the medical device in the ARTG
Implementing a comprehensive post market
vigilance and adverse incident reporting program
38
blood pressure monitors
breast implants
Catheters
lubricating eye drops
MRI scanners
Syringes
tongue depressors
39. Key elements of the medical device regulatory
scheme
39
Essential Principles for the quality, safety and
performance of the medical device that must be
complied with:
1. before the device is supplied to the market in
Australia, and
2. on an ongoing basis while the device is supplied
to the market in Australia
40. 40
ongoing monitoring of medical devices that are
available on the market
regulatory controls for the manufacturing processes of
medical devices
the Australian Register of Therapeutic Goods (ARTG)
as the central point of control for the legal supply of
medical devices in Australia
the provision for imposing penalties where regulatory
requirements are breached
a range of corrective actions that may be taken if there
is a problem with a device
41. Blood and tissues
41
Blood,
Blood components,
Plasma derivatives,
Tissue and cellular products, and
Tissue cell based derivatives,
Regulated under the Therapeutic Goods Act 1989.
42. 42
Chemicals
The Office of Chemical Safety undertakes the risk
assessment and provides advice on potential public
health risks posed by chemicals used in community.
Example includes :
Cosmetics, Agricultural,
Veterinary, Industrial Chemicals,
Pesticides, Environmental chemical,
Cosmetic claim guidelines.
43. Exempt or excluded
medicines
43
All medicines manufactured for supply in
Australia must be listed or registered in the
Australian Register of Therapeutic Goods
(ARTG) unless they are exempt or excluded
44. 44
Excluded
Some products (mostly therapeutic devices,
rather than medicines) may be unintentionally
covered by the definition of a Therapeutic Good.
They are therefore specifically excluded under
section 7 of the Act.
An example of an excluded good is unmedicated
soap.
45. 45
Exempt
Some medicines do not need to be registered or
listed in the ARTG as a result of a specific
exemption or determination. However, it is
important to note that all other applicable
requirements under the Act and Regulations (eg.
standards and advertising or labelling) must be
complied with.
46. MEDICINES AND HEALTHCARE
PRODUCTS REGULATORY AGENCY
(MHRA)
46
What is MHRA?
The MHRA was set up in April 2003 from a
merger of the Medicines Control Agency and the
Medical Devices Agency. The MHRA is the
government agency which is responsible for
ensuring that medicines and medical devices
work, and are acceptably safe.
47. Aims of MHRA
47
Protecting public health through regulation,
with acceptable benefit-risk profiles for
medicines and devices.
Promoting public health by helping people who
use these products to understand their risks and
benefits.
Improving public health by encouraging and
facilitating developments in products that will
benefit people.
48. Objectives of MHRA
48
Safeguard public health through MHRA’s primary role in
ensuring that the products MHRA regulate meet required
standards, that they work and are acceptably safe;
Carry out communication role through the provision of
accurate, timely and authoritative information to
healthcare professionals, patients and the public;
Support research, ensuring through the application of
Better Regulation principles that regulation does not stifle
innovation;
Influence the shape of the future regulatory framework
through use of our effective European and International
relationships;
Run an organisation with a skilled and equipped
workforce that is fit for the future
49. The MHRA's activities
49
Assessing the safety, quality and efficacy of
medicines, and authorising their sale or supply in the
UK for human use.
Overseeing the UK Notified Bodies that audit medical
device manufacturers.
operating post-marketing surveillance and other
systems for reporting, investigating and monitoring
adverse reactions to medicines and adverse incidents
involving medical devices and taking any
necessary action to safeguard public health, for example
through safety warnings, removing or restricting the
availability of products or improving designs.
Operating a proactive compliance programme for
medical devices.
50. 50
Operating a quality surveillance system to sample
and test medicines and to address quality defects,
monitoring the safety and quality of imported
unlicensed medicines and investigating Internet
sales and potential counterfeiting of medicines.
Regulating clinical trials of medicines and medical
devices.
Monitoring and ensuring compliance with
statutory obligations relating to medicines and
medical devices through inspection, taking
enforcement action where necessary.
51. 51
Promoting good practice in the safe use of
medicines and medical devices.
Managing the General Practice Research Database
(GPRD) and the British Pharmacopoeia (BP) and
contributing to the development of performance
standards for medical devices.
Offering scientific, technical and regulatory
advice on medicines and medical devices.
Providing the public and professions with
authoritative information to enable informed
dialogue on treatment choices.
52. MHRA’s structure:
52
Corporate governance
1. The Agency Board is made up of a non-executive
Chairman, six non-executive members and the Agency's
Chief Executive Officer who is responsible for service
delivery and resources.
2. The Executive Board consisting of the Agency's
directors takes overall responsibility for day-to-day
management, strategic decision-making, line
management, and all financial, policy, operational and
resource management issues.
3. The Risk and Audit Committee provides independent
feedback to the Chief Executive and the Management
Board on the effectiveness of risk management processe
53. What MHRA regulates?
53
Medicine
Licencing of medicines
Medicines for children
Inspection and standards
Importing and exporting medicines
Best practice guidance on labelling and packaging of medicines
The safety of medicines
54. The role of MHRA
54
Assess applications for marketing medicinal
products
Assess applications to undertaken clinical trials
Inspect the manufacturers and wholesalers of
medicines-licensing
Undertake post-marketing surveillance
including:
Pharmacovigilance
Quality defect monitoring
Sampling and testing
Product recalls.
55. 55
Issue certificates to companies wishing to
export their medicinal products to countries
outside the EU.
Enforce the statutory requirements covering
medicines control and good clinical practice
guidelines.
Publish quality standards for drug substances
through the "British Pharmacopoeia
56. Medical devices
56
Medical device agency (MDA) regulates medical
device (instruments, apparatus, appliances,
material and software used alone or in the
combination to prevent, diagnose, treat disease
or alter pharmacologic
Aim:
Take all reasonable steps to protect the public
health ensuring medical devices and equipment
meet appropriate standards, safety, quality and
performance in European Union.
Toiletry and cosmetics products, personal
protective equipment are not included in medical
deviceogical
57. Advanced Therapeutic Medicinal Product (ATMP)
57
An ATMP is a medicinal product which is either:
a gene therapy medicinal product
a somatic cell therapy medicinal product
a tissue engineered product
The ATMP Regulation came into force on 30
December 2007. The provisions of the
Regulation applied from 30 December 2008
action of the body