The regulation of complementary medicines
•Download as PPTX, PDF•
13 likes•3,626 views
The Therapeutic Goods Administration (TGA) regulates complementary medicines in Australia using a risk-based, two-tiered system. Lower risk listed medicines can be marketed with minimal pre-market evaluation, while higher risk registered medicines require pre-market assessment of quality, safety and efficacy. The TGA oversees post-market monitoring and compliance reviews to ensure that medicines meet regulatory requirements. Guidance materials provide information on evidence requirements and the different pathways for listed and registered complementary medicines.
Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (12)
Similar to The regulation of complementary medicines
Similar to The regulation of complementary medicines (20)
More from TGA Australia
More from TGA Australia (20)
Recently uploaded
Recently uploaded (20)
The regulation of complementary medicines
- 1. The regulation of complementary medicines Yasmin Mollah Assistant Director, Listing Operations Angeliza Querubin Pre-Market Assessment Section Complementary medicines branch, TGA Capsig NSW - Complementary medicines - revival 25/3/2015
- 2. Therapeutic Goods Administration What do we do? • Established in 1989 • Department of Health of Australia • Safeguard health of Australian public • Regulates therapeutic goods – Medicines and medical devices
- 3. TGA Structure National Manager Market Authorisation Division Medicines Authorisation Branch Complementary Medicines Branch Devices Authorisation Branch Scientific Evaluation and Special Product Access Branch Monitoring and Compliance Division Regulatory Compliance Branch Manufacturing Quality Branch Laboratories Branch Post Market Surveillance Branch Regulatory Support Division Regulatory Business Services Branch Regulatory Engagement, Education and Planning Branch Regulatory Legal Services Branch Regulatory knowledge and Technology Services Branch Regulatory Business Improvement Branch 2
- 4. Complementary Medicines Branch Market Authorisation Group MAB (Medicines) CMB (Complementary Medicines) Regulatory Reform & Coordination Pre-market Assessment Listing and Operations Listing Compliance DAB (Medical Devices) SESPAB (Scientific Evaluation) 3
- 5. What are Complementary Medicines? Capsig NSW - Complementary medicines - revival 4
- 6. The TGA does not regulate: • Practitioners, such as naturopaths, traditional Chinese Medicine practitioners • Complementary medicines that are dispensed or extemporaneously compounded by healthcare practitioners for individual patients Regulated at a State/Territory level 5
- 7. Risk based regulation of medicines Australia has a risk-based approach with a two-tiered system for the regulation of all medicines, including complementary medicines Lower risk medicines listed on the Australian Register of Therapeutic Goods AUSTL Higher risk medicines registered on the ARTG AUSTR 6
- 8. Risk based approach • Pre-market evaluation • Medicine focussed • May have restrictions on access • Higher level claims • Identified by “AUST R” number RISK Registered Listed • No restrictions on access • Low and medium level claims • May have restrictions: quantities, dosage form, route of admin, plant part, etc • Enter ARTG via the Electronic Listing Facility (ELF) • Sponsor makes certifications against requirements • Evidence for claims monitored ‘post-market’ • Id. by “AUST L” number Capsig NSW - Complementary medicines - revival 7
- 9. Determinants of Risk • Ingredients • Dosage form • Indications and claims • Significance of side effects • Effects of prolonged use or inappropriate self-medication Capsig NSW - Complementary medicines - revival 8
- 10. Is it eligible for Listing? Eligibility requirements Approved ingredients Preparation not in SUSMP Qty restrictions not exceeded Not required to be sterile Herbal ingredients meet definition of “herbal substance” Indications do not refer to disease / condition in Appendix 6 of TGAC Sponsor certifies medicine eligible for Listing ELF validation can pick up some ‘ineligibility’ Listing Capsig NSW - Complementary medicines - revival 9
- 11. Listed Medicines Regulatory Framework Listed on ARTG • Streamlined online application & validation process • Sponsor certify meets legislation requirements • No premarket efficacy evaluation Retail supply to Australian market place Compliance review Unique Regulatory Framework Evidence sourced from open literature Regulatory framework consistent with low risk medicines Quick & easy market access Pre-approved ingredients Market share established Fully compliant Non compliant ??? Cancelled from ARTG Capsig NSW - Complementary medicines - revival 10
- 12. Post-listing regulatory activities Risk based regulatory approach includes: • desk-based audits of listed medicines • laboratory testing of products and ingredients • surveillance in the marketplace • monitoring of adverse reactions • recalls procedure • audit of manufacturing sites • controls for advertising 11
- 13. Type of Compliance Reviews for LMs Investigations • Triage of complaints into highest priority target review Target Reviews • Often triggered from complaint or intelligence report • Specific information is reviewed to address concerns • Comprehensive evidence reviews Random Reviews • Newly LMs are randomly selected • Standard set of information is reviewed Target Reviews (Narrow scope) Random Reviews (broad scope) Investigations (triage) Capsig NSW - Complementary medicines - revival 12
- 14. Compliance Review Review Evidence Claims / indications: relevance, quality Labelling Correct format Presentation Advisory statements Manufacturing Licence / valid clearance Finished Product Specifications 13
- 15. Listing Compliance Review Process Medicine listed on ARTG Compliance review Request for information (s31 of Act ) Assessment of information against relevant legislative requirements Direct cancellation ss30(1C) or (1A) Cancel medicine from ARTG compliance issues identified Propose to Cancel (P2C) Address all non- compliance issues of P2C Medicine remains on ARTG Cancellation ss30(2) Cancel medicine from ARTG Fully compliant Medicine remains on ARTG Sponsor review listing & address issues Capsig NSW - Complementary medicines - revival 14
- 16. Does the indication match the evidence? • Scientific indications are supported by scientific evidence • Traditional indications are derived from a tradition of use within a paradigm • Format of 2 types of indications are different on the medicine label • According to the current Evidence Guidelines1 – Is the evidence relevant? • Equivalent doses; plant part – Is it high quality evidence? • Systematic reviews, methodological sound – Is it a balanced view? • Positive evidence > equivocal/negative 1Guidelines for levels and kinds of evidence to support indications and claims (2011) Increasingquality 15
- 17. Traditional Use – Indications & Evidence • Evidence of Traditional Use: – well-established tradition of use for its intended purpose >75 years and includes: how it has been used during that time the continuity of its use; and the geographical extent of its use. • Example of traditional indication: – Traditionally used in Western herbal medicine to relieve nasal congestion • Sources include: – National formularies – materia medica – official pharmacopoeias; and – monographs Capsig NSW - Complementary medicines - revival 16
- 18. Evidence guidelines Capsig NSW - Complementary medicines - revival 17
- 19. Registered complementary medicines • Higher risk than listed medicines based on the ingredients and/or therapeutic indications • identified on the label by ‘AUST R’ followed by a number • Medicines must be registered on ARTG, where they: – Don’t solely comprise ingredients permitted for use in listed medicines – Contain an ingredient subject to the conditions of Poisons Standard e.g. Pharmacist Only vitamins/minerals must be registered – Are required to be sterile – Have indications that make higher level claims that are not allowed in listed medicines • Registered complementary medicines may be subject to the conditions of a Schedule of Poisons Standard 18
- 20. Registered complementary medicines • Pre-market evaluation is undertaken to establish quality, safety and efficacy of the medicine prior to approval for entry on the ARTG • Data requirements and evaluation are consistent with other OTC or prescription medicines • Evaluation includes determining whether the medicine complies with all applicable legislative requirements • Application data typically follows scheme used in the Common Technical Document (CTD), an internationally-agreed format for approval of new drugs adopted by TGA in 2004 19
- 21. Registered Medicines – Safety & Efficacy Data Overview • Literature search strategy • History and pattern of human use • International regulatory status • Pharmacodynamics, pharmacokinetics, safety pharmacology, drug interactions • Toxicology: acute, chronic/subchronic, genotoxicity, carcinogenicity, reproductive & developmental etc. • Clinical trials • Adverse event reports in Australia and overseas 20
- 22. Registered Medicines – Quality Data Overview • Structural formula of the ingredient or components • Physiochemical and other relevant properties • Manufacturing details • Characterisation of ingredient or components • Control of substance: specifications, analytical procedures, batch certificate of analysis, justification of specifications • Reference standards • Stability data • Container/closure system 21
- 23. The Challenge Managing industry innovation with consumer safety Minimal regulatory burden Industry Consumer 22
- 24. Guidance material Recently updated • Australian Regulatory Guidelines for Complementary Medicines (ARGCM) 23
- 25. Questions Subscribe to Updates: www.tga.gov.au/newsroom/subscribe.htm Information on reforms: www.tga.gov.au/industry/cm-reforms.htm Capsig NSW - Complementary medicines - revival 24
Editor's Notes
- What is the Therapeutic Goods Administration? The Therapeutic Goods Administration, also known as the ‘TGA’, is a Division of the Australian Department of Health. It was established in 1989. The purpose of the TGA is to safeguard the health of the Australian public. The TGA does this by regulating therapeutic goods before they are available to the Australian public. This work is the ‘pre-market’ work of the TGA. Another important role of the TGA is to monitor and review therapeutic goods after they are available to the public. This is to make sure that therapeutic goods in Australia continue to be safe for use. This is the ‘post-market’ work of the TGA. Therapeutic goods include both medicines and medical devices. TGA also regulates biologicals.
- As shown on the diagram, the TGA is divided into three sections. The National Manager, Professor John Skerritt, is the head of the TGA. The three different sections, or ‘groups’ of the TGA are: The Market Authorisation Group The Monitoring and Compliance Group and The Regulatory Support Group The Market Authorisation Group takes care of the pre-market space of therapeutic goods. That is, they evaluate and assess products before they are available to the Australian public. The Monitoring and Compliance group takes care of the post-market space. They make sure that products accessible to the Australian public are safe. They also make sure that therapeutic products comply with the law. The Regulatory Support Group provides corporate support to everyone at the TGA. They also deal with the business side of the TGA. The Office of Complementary Medicines, or OCM, is found within the Market Authorisation Group. The OCM is unique because it also monitors and reviews products after it becomes accessible to the Australian public. This is usually the role of the Monitoring and Compliance Group.
- Within the Market Authorisation Group, there are a number of different offices. Each office generally looks after a certain class of therapeutic goods. For example, The OMA is the Office of Medicines Authorisation. This office evaluates prescription medicines and over-the-counter medicines. The OCM oversees the regulation of complementary medicines in Australia. The ODA is the Office of Devices Authorisation. The ODA is in charge of medical devices. And the OSE is the Office of Scientific Evaluation. This office looks after toxicology, pharmaceutical chemistry and biological sciences, including blood and tissues products. The Office of Complementary Medicines contains four sections.
- Australia has a risk-based approach with a two tiered system for the regulation of all medicines, including complementary medicines. Medicines are either listed or registered on the Australian Register of Therapeutic Goods (ARTG), depending on the claims that are made bout the medicines, and the benefits and risks associated with using it. Lower risk medicines are listed medicines are include an “AUSTL” on the label. Higher risk medicines are registered medicines and include an “AUSTR” on the label.
- Compliance Reviews Information reviewed by the TGA can generally be divided into three categories: Evidence Claims made about the product are compared to the evidence provided by the sponsor. Evidence is assessed for its quality and relevance to the product. Labelling Product labels are reviewed to ensure that they comply with Therapeutic Goods Order 69 (TGO 69)– General requirements for labels for medicines. Manufacturing TGA will check to ensure that manufacturing documents comply with the relevant standards.
- When regulating complementary medicines, the OCM must balance industry’s needs with consumer safety. As shown on the slide, it is a balancing act between making products available whilst making sure that they are safe and of high quality.
- The OCM has developed some guidance materials to help the industry understand the complementary medicines regulatory framework. We have recently updated the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). This is our main guidance document. The Guidelines on the Evidence Required to Support Indications and Claims for Listed Complementary Medicines is another important document for industry.