Therapeutic goods administration

australia

1. Therapeutic Goods Administration An introduction to the work of Australia’s regulator of therapeutic goods

2. Why do we need regulation? 2 Australian doctor William McBride alerted the world to the dangers of thalidomide in the 1960s which triggered the need for an Australian regulator of therapeutic goods. “In recent months I have observed that the incidence of multiple severe abnormalities in babies delivered of women who were given the drug thalidomide (‘ Distival ’) during pregnancy, as an anti-emetic or as a sedative, to be almost 20%.”

3. Who is Australia’s regulator? 3 The Therapeutic Goods Administration was established in 1990 to “ safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods” It provides a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in, or exported from, Australia Health Safety Regulation

4. TGA - ORGANISATION 4 TGA is part of the Australian Government Department of Health Every decision the TGA makes is based on the Therapeutic Goods Act 1989 Main offices in Canberra – satellite offices in Sydney, Melbourne, Adelaide and Brisbane

5. Who works at the TGA? 5 Approximately 750 staff made up of: Biomedical scientists Engineers Physiotherapists Medical officers Pharmacists Nurses Toxicologists Lawyers Nutritionists Dieticians Scientists Administrative staff

6. TGA STRUCTURE   The TGA Regulatory offices are grouped into : Market Authorization Group Monitoring and Compliance Group Regulatory Support Group TGA Executive: The TGA Executive has overall responsibility for the management of the TGA's regulatory activities .

7. The TGA Executive:-

8. Market Authorization Group Undertake 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.

9. 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.

10. 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 .

11. 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  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)

12. TGA’s mission 12 To safeguard and enhance the health of the Australian community through the effective and timely regulation of therapeutic goods . Health Safety Regulation

13. How TGA fulfil this mission? 13 1 2 3 Good Manufacturing Practice or Manufacturing Principles: licensing Australian manufacturers and verifying compliance of overseas manufacturers (see the TGA education module on GMP) Premarket assessments: assessing therapeutic goods for quality and safety (the extent of the assessment depends on the type of product and level of associated risk), and for higher risk products also for efficacy or performance Postmarket assessments: monitoring of therapeutic goods and enforcement of standards (see the TGA education module on postmarket monitoring)

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

15. Australian register of therapeutic goods (ARTG ) 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

16. Under the Therapeutic Goods Act 1989, therapeutic goods are defined as: 16 Products for use in humans in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury influencing, inhibiting or modifying a physiological process testing the susceptibility of people to a disease or ailment influencing, controlling or preventing conception testing for pregnancy replacing or modifying parts of the anatomy All these products are therapeutic goods!

17. The benefit versus risk approach 17 No therapeutic good is risk free The work of the TGA is based on applying scientific and clinical expertise to decision making E nsure that the benefits outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods

18. Types of therapeutic goods 18

19. Australian Register of Therapeutic Goods 19 All goods must be entered in the ARTG before they can be supplied in, imported to, or exported from Australia higher risk medicines that are registered on the ARTG evaluated for quality, safety and efficacy Product Information is approved by the TGA All   prescription medicines Most   over-the-counter medicines Some   complementary medicines lower risk medicines that are listed on the ARTG contain pre-approved, low risk ingredients can only make limited claims and cannot imply that they will be useful in the treatment or prevention of serious illnesses Some over-the-counter medicines Most complementary medicines higher risk devices are evaluated for quality, safety and performance lower risk devices are not evaluated for performance Devices are classified according to their level of risk, ranging from Class I (lower risk) such as urine collection bottles to Class III (higher risk) such as antibiotic bone cements Registered medicines Listed medicines Medical devices 19

20. Registered medicines R egistered medicines have an   'AUST R ' number on the label and/or packaging There is a large amount of information to consider It takes approximately 11 months to evaluate one new higher risk prescription medicine Evaluation is undertaken by scientists and clinicians who look at data on: Quality Safety and efficacy

21. Process of checking and communicating with applicant 1. Preparation and lodgement 2. Screening 3. Evaluation 4. Decision 5. Finalisation

22. Once approved for marketing in Australia, medicines are included in the ARTG and can be identified by the AUST R number (for registered medicines) or an AUST L number (listed medicines) that appears on the packaging of the medicines . Medicines that are assessed to be higher risk are individually evaluated for quality, safety and efficacy. Higher risk products approved by the TGA are included on the ARTG as registered medicines. Listed medicines are low risk medicines and are included on the ARTG via low-cost and streamlined electronic application and validation process

23. Whether a product is listed or registered in the ARTG depends largely on three things:

24. In assessing the level of 'risk', factors such as

25. 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 .

26. The PI should contain information under the following headings

27. . 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) 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.

28. 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; They are evaluated as either 'high risk' or 'low risk' registered if they are prescription medicine or non- prescription medicine respectively.

29. Prescription medicines Non-prescription medicines High-risk Registered products. This group includes all prescription medicines and some specified products such as sterile injectables . lower risk than prescription medicines 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 time frames; 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 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. I f a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia I f the label of the goods does not declare the presence of a therapeutically active ingredient

35. Medical devices Medical Devices Evaluation Committee (MDEC) 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 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

36. Examples of medical devices include blood pressure monitors breast implants Catheters lubricating eye drops MRI scanners Syringes tongue depressors

37. Key elements of the medical device regulatory scheme is to ensure quality , safety and performance of the medical device that must be complied: B efore the device is supplied to the market in Australia, OR on an ongoing basis while the device is supplied to the market in Australia 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 Provision for imposing penalties where regulatory requirements are breached Range of corrective actions should be taken if there is a problem with a device.

38. Blood and tissues It include  Blood,  Blood components  Plasma derivatives  Tissue and cellular products  Tissue cell based derivatives It is Regulated under the Therapeutic Goods Act 1989.

39. 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 use chemicals.

40. . Excluded:-. 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.

41. Exempt or excluded medicines Excluded medicines are 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 . Exempt medicines do not need to be registered or listed in the ARTG as a result of a specific exemption or determination. 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

42. REFERENCES https:// www.tga.gov.au https :// en.wikipedia.org/wiki/Therapeutic_Goods_Administration