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

2. List of 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. UK-MHRA 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. Advanced therapeutic medicinal product Nanotechnology Blood References
What MHRA regulates ?
Device
Medicine
Advanced therapeutic medicinal product
Nanotechnology
Blood
References

5. THERAPEUTIC GOODS ADMINISTRATION(TGA)
What is TGA?
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.

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
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. Post-market monitoring, through sampling, adverse event reporting, surveillance activities, and response to public inquiries;
The assessment of medicines for export.

9. TGA structure
The TGA's offices are grouped into three core groups - Market Authorisation Group, Monitoring and Compliance Group and Regulatory Support Group
CHART
TGA Executive
Market Authorization Group (MAG )
Monitoring and Compliance Group (MCG)
Regulatory Support Group
Office of Regulatory Integrity(ORI)

10. 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. Market Authorization Group (MAG)
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. Monitoring and Compliance Group (MCG)
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. Regulatory Support Group
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. Office of Regulatory Integrity(ORI)
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
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. 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)
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. 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. 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. 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
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. 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)
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. 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
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. Most complementary medicines (eg
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
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. Prescription (high risk) registered
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
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
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
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
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. 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
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
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. Prescription Medicines Include a new medicine in the ARTG that are evaluated by the Drug Safety and Evaluation Branch (DSEB) of the TGA

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. including the medical device in the ARTG
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
Examples of medical devices include:
blood pressure monitors
breast implants
Catheters
lubricating eye drops
MRI scanners
Syringes
tongue depressors

39. Key elements of the medical device regulatory scheme
Essential Principles for the quality, safety and performance of the medical device that must be complied with:
before the device is supplied to the market in Australia, and
on an ongoing basis while the device is supplied to the market in Australia

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
Blood,
Blood components,
Plasma derivatives,
Tissue and cellular products, and
Tissue cell based derivatives,
Regulated under the Therapeutic Goods Act

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
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. 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. 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)
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
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
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
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. 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. 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: Corporate governance
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.
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.
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? 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
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. 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
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)
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 The provisions of the Regulation applied from 30 December 2008 action of the body

58. References:

59. THANK YOU
- PHARMA STREET