Presentation: New pathway for complementary medicines
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The document outlines a seminar on regulatory obligations for complementary medicines, proposing three assessment pathways for ARTG entry that enable increased consumer transparency and support sponsor innovation. A new pathway is introduced, allowing intermediate claims and requiring TGA assessment for efficacy, along with compliance with GMP standards. Public consultation showed broad support for the new pathway, although concerns were raised regarding the exclusion of traditional medicines.
Presentation: New pathway for complementary medicines
- 1. Complementary Medicines Regulatory Obligations Seminar Improving access to evidence based listed complementary medicines Lyndall Soper Assistant Secretary, Complementary and OTC Medicines Branch Medicines Regulation Division, TGA Complementary Medicines: Regulatory Obligations Seminar
- 2. Recommendation 39 3 assessment pathways for complementary medicines Panel recommendation: 3 options by which sponsors may seek ARTG entry for complementary medicines: Option 1: Listing in the ARTG following self-declaration by the sponsor regarding safety, quality and efficacy (current listing pathway) Option 2: Listing in the ARTG following self-assessment of the safety and quality but a TGA assessment for efficacy (new pathway) Option 3: Registration in the ARTG following full TGA assessment of safety, quality and efficacy (current registered pathway) Complementary Medicines: Regulatory Obligation Seminar 1
- 3. Recommendation 39 Three assessment pathways for complementary medicines Government Response The Commonwealth accepts the recommendation; noting that legislative amendments are required to implement Option Two. Implementing this recommendation would increase transparency for consumers, provide additional flexibility for sponsors and support innovation. Complementary Medicines: Regulatory Obligation Seminar 2
- 4. New Pathway: Key Features • A new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways • Maintains low risk status based on their ingredients, the way they are presented and the potential harm associated with their use • Can use ‘intermediate claims’ which are not included on the permitted indications list: Low level indication: ‘May help relieve muscle aches and pains’ Intermediate level indication: ‘May help relieve arthritis’ Complementary Medicines: Regulatory Obligation Seminar 3
- 5. New Pathway: Key Features cont. • Still required to comply with GMP requirements • TGA evaluates the evidence for efficacy before it is listed • Option to include a claimer on all promotional material stating it has been independently assessed. – ‘The efficacy of the product has been independently assessed for the approved indication’ – ‘Evidence has been reviewed by the TGA’ Complementary Medicines: Regulatory Obligation Seminar 4
- 6. Proposed Complementary Medicines Framework Listed Medicines New Pathway Registered Medicines Permitted ingredients Permitted ingredients Not limited to selecting from permitted ingredients list Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Low level permitted indications only At least one ‘intermediate indication’ May have higher level indications No pre-market assessment Pre-market assessment of evidence for efficacy Full pre-market assessment Ability to claim that efficacy has been assessed Complementary Medicines: Regulatory Obligation Seminar 5
- 7. Indications to accepted through the new pathway Listed medicines New pathway Registered medicines Low level indications may refer to: • health enhancement • health maintenance • prevention/alleviation of dietary deficiency • a health benefit for a non- serious disease or condition (symptomatic relief) Eg: maintain/support healthy bones Intermediate level indications may refer to: • a health benefit for a serious disease (i.e. restricted representations) • prevention, alleviation or management of a non-serious disease or condition (of a higher risk to consumers than low level indications) Eg: prevention of osteoporosis High level indications may refer to the; • prevention • alleviation, • cure or • management of a serious form of a disease, ailment, defect or injury (restricted reps) Must not refer to a prohibited representation 6
- 8. Proposed approaches to establishing efficacy 1. Sponsors all medicines must meet minimum evidence requirements 2. Existing approaches to establish efficacy for listed and registered complementary medicines will be retained 3. For the new pathway: • The evidence requirements can be met in two ways (Method 1 or Method 2) • Sponsor will self-assess the safety and quality (permitted ingredients, compliance with quality standards and GMP) Complementary Medicines: Regulatory Obligation Seminar 7
- 9. Proposed Categories of Evidence Category A Category B Category C Category D Traditional Reference text Non-systematic, generalised reviews - including databases Observational studies e.g. cohort and case control studies Double blind randomised controlled trials (including cross-over trials) Herbal Monograph Publicised international Regulatory Authority Articles Comparative studies (non-control) Systematic reviews Herbal Pharmacopoeia Evidence based reference text - scientific Materia Medica Scientific Monographs Publicised International Regulatory Authority Articles – Traditional only Pharmacopoeias Complementary Medicines: Regulatory Obligation Seminar 8
- 10. Proposed minimum literature requirements Listed medicines New Pathway Registered medicines Indication Traditional Low Level Scientific Intermediate Level Indications Non-prohibited Indications Evidence Category Required evidence Minimum of two independent sources from Category A OR A minimum of one from Category B Minimum of two independent sources from Category B PLUS (where required) A minimum of one from Category C Primary indication Minimum of one from Category D OR Minimum of 2 independent sources from Category B, AND a minimum of one from Category C Primary indication Minimum of one from Category D Evidence Category Supplementary evidence Minimum 1 from Category A to support specific therapeutic claims (where relevant) Minimum of 1 from Category B to support specific therapeutic claims (where relevant) Secondary indications One from Category D OR Minimum of 2 independent sources from Category B, AND a minimum of one from Category C Secondary indications One from Category D OR Minimum of 2 independent sources from Category B, AND a minimum of one from Category C Complementary Medicines: Regulatory Obligation Seminar 9
- 11. Options for submission of efficacy evidence Method 1: • Clinical Trial data on the finished product that supports the specific indication – Potential 3 years data protection. Method 2: • A data package containing: – evidence for efficacy of all ingredients; AND – evidence for efficacy of the product formulation; (e.g. bioavailability data and/or dissolution testing) AND – justification of the combination of ingredients. 10
- 12. Proposed evidence dossier requirements for New Pathway Data Type Method 1 Method 2 Primary indication A minimum of one randomised controlled clinical trial (including cross-over trial) or systematic review on the product. A minimum of one randomised controlled clinical trial (including cross-over trial) or systematic review on each active ingredient. Body of scientific information Full literature search report on the product or formulation. Full literature search report on all active ingredients and formulation. Non-clinical data N/A Dissolution data and bioequivalence data on the product. Formulation N/A Justification of the use of the particular combination of ingredients, including potential interactions. Quality Evidence of GMP. Evidence of GMP. Complementary Medicines: Regulatory Obligation Seminar 11
- 13. Examples of products and evidence packages suitable for the New Pathway Product Type Example of products Standard product (e.g. multiple active ingredients) Method 1 A sponsor proposes to list a product consisting of 1000 IU of Vitamin D (cholecalciferol 25 micrograms) and 1200 mg calcium indicated for reducing the risk of fractures associated with osteoporosis. The sponsor has evidence from multiple clinical trials and a systematic review of the literature indicating that daily supplementation with the product reduces the risk of fractures associated with osteoporosis. Single ingredient active (immediate release only) with established bioavailability Method 2 A product contains 450 micrograms of folic acid. The sponsor wishes to use the restricted representation ‘prevents neural tube defects when used during the first trimester of pregnancy’. The sponsor can provide dissolution studies indicating that the product results in appropriate release of the active, and full literature search supporting the indication. 12
- 14. Initial outcomes of public consultation New Pathway • Broad support for the introduction of the new pathway Efficacy evidence • General support for the proposed evidence hierarchy • Significant concerns around excluding traditional medicines from the new pathway • Some industry stakeholders feel there is too much emphasis on the finished product Complementary Medicines: Regulatory Obligation Seminar 13
- 15. Recommendation 45: Claimers for assessment of efficacy Panel Recommendation: Where a medicinal product is listed in the ARTG following an assessment by the TGA of an application under Option Two, the sponsor is able to indicate on all promotional materials and on the product label, that the efficacy of the product has been independently assessed for the approved indications. Government response: Accepts-in-principle Recommendation 45, noting that the design and use of the promotional statements will require careful consideration by the TGA and further consultation with stakeholders. Complementary Medicines: Regulatory Obligation Seminar 14
- 16. Features of the claimer • The use of a claimer is optional • Must be supported by the appropriate level of scientific evidence for all indications made for the medicine • Must not imply superiority of the product over other medicines that have been pre-market assessed (e.g. OTC, prescription) • Must comply with advertising requirements • Must not be more prominent or detract from the label information mandatorily required by the current Labelling Order Complementary Medicines: Regulatory Obligation Seminar 15
- 17. Who can use the claimer? • A claimer can be used by medicines that have had TGA pre-market assessment: – Complementary medicines assessed via the new pathway – Registered complementary medicines • A claimer cannot be used by medicines that have not had a pre-market assessment: – Listed medicines – including those that have been subject to a post market compliance review – “Grandfathered” medicines Complementary Medicines: Regulatory Obligation Seminar 16
- 18. Possible presentation of claimers Option 1: The claimer as a statement • ‘The efficacy of the product has been independently assessed for the approved indication’ • ‘Evidence has been reviewed by the TGA’ Option 2: A visual identifier as well as statement Implementation and design Claimers will be: • standardised and easily recognisable by consumers • appropriately placed on label and promotional material to not detract from essential product information Complementary Medicines: Regulatory Obligation Seminar 17
- 19. Initial outcomes of public consultation Claimer on promotional material • Generally well supported by consumer groups, industry and healthcare professionals • Strong support for an appropriate education campaign to accompany the introduction of a claimer Complementary Medicines: Regulatory Obligation Seminar 18
- 20. Questions? Complementary Medicines: Regulatory Obligation Seminar 19
Editor's Notes
- #11: All evidence will be subject to minimum requirements for relevance, quality and consistency.