THERAPEUTIC GOODS ADMINISTRATION (TGA) & MEDICINES AND HEALTH CARE PRODUCTS REGULATORY AGENCY (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

4. 4
 What MHRA regulates ?
 Device
Medicine
 Advanced therapeutic medicinal product
Nanotechnology
Blood
 References

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

58. References:
58
http://www.tga.gov.au
http://www.mhra.gov.uk