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
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
TGA Structure National Manager Monitoring and Compliance Market Authorisation Regulatory Support Division Division Division Regulatory Business Medicines Authorisation Regulatory Compliance Services Branch Branch Branch Regulatory knowledge and Complementary Medicines Manufacturing Quality Technology Services Branch Branch Branch Regulatory Engagement, Education and Planning Devices Authorisation Branch Branch Laboratories Branch Regulatory Business Scientific Evaluation and Improvement Branch Post Market Surveillance Special Product Access Branch Branch Regulatory Legal Services Branch 2
Complementary Medicines Branch Market Authorisation Group CMB SESPAB MAB DAB (Medical (Scientific (Complementary Devices) (Medicines) Evaluation) Medicines) Regulatory Pre-market Listing Listing and Reform & Assessment Compliance Operations Coordination 3
What are Complementary Medicines? Capsig NSW - Complementary 4 medicines - revival
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
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
Risk based approach • No restrictions on access • Low and medium level RISK claims • Pre-market evaluation • May have restrictions: • Medicine focussed quantities, dosage • May have restrictions form, route of admin, on access plant part, etc • Higher level claims • Enter ARTG via the • Identified by “AUST R” Registered Electronic Listing number Facility (ELF) • Sponsor makes certifications against requirements • Evidence for claims monitored ‘post-market’ Listed • Id. by “AUST L” number Capsig NSW - Complementary 7 medicines - revival
Determinants of Risk • Ingredients • Dosage form • Indications and claims • Significance of side effects • Effects of prolonged use or inappropriate self-medication Capsig NSW - Complementary 8 medicines - revival
Is it eligible for Listing? Eligibility requirements Approved Preparation Qty restrictions Not required ingredients not in SUSMP not exceeded to be sterile Indications do not refer to disease Herbal ingredients meet definition / condition in Appendix 6 of TGAC of “herbal substance” Sponsor certifies medicine eligible for Listing ELF validation can pick up some ‘ineligibility’ Listing Capsig NSW - Complementary 9 medicines - revival
Listed Medicines Regulatory Framework Market share Evidence Quick & easy established sourced from market open literature access Listed on ARTG Retail supply to Australian market • Streamlined online place application & validation process Compliance • Sponsor certify meets ??? legislation requirements review Cancelled • No premarket efficacy from ARTG evaluation Unique Regulatory Framework Regulatory framework Pre-approved consistent with low ingredients risk medicines Fully compliant Non compliant Capsig NSW - Complementary 10 medicines - revival
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
Type of Compliance Reviews for LMs Investigations • Triage of complaints into highest priority target review Target Reviews Investigations (triage) • Often triggered from complaint or intelligence report • Specific information is reviewed to address concerns Random • Comprehensive evidence reviews Reviews (broad scope) Random Reviews • Newly LMs are randomly selected • Standard set of information is Target Reviews (Narrow scope) reviewed Capsig NSW - Complementary 12 medicines - revival
Compliance Review Claims / indications: Evidence relevance, quality Correct format Review Labelling Presentation Advisory statements Licence / valid clearance Manufacturing Finished Product Specifications 13
Listing Compliance Review Process Sponsor review listing & address issues Medicine listed on ARTG Direct Compliance review Cancel medicine cancellation from ARTG Request for ss30(1C) or (1A) information Cancellation Cancel medicine (s31 of Act ) from ARTG ss30(2) Address all non- Assessment of Propose to compliance Medicine remains information against compliance Cancel (P2C) issues identified on ARTG relevant legislative issues of P2C requirements Medicine remains Fully compliant on ARTG Capsig NSW - Complementary 14 medicines - revival
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 Increasing quality According to the current Evidence Guidelines 1 • – 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 1 Guidelines for levels and kinds of evidence to support indications and claims (2011) 15
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 16 medicines - revival
Evidence guidelines Capsig NSW - Complementary 17 medicines - revival
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
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
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
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
The Challenge Managing industry innovation with consumer safety Minimal regulatory burden Consumer Industry 22
Guidance material Recently updated • Australian Regulatory Guidelines for Complementary Medicines (ARGCM) 23
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 24 medicines - revival
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