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TGA response: Australian regulatory guidelines for complementary medicines (ARGCM)

16 December 2013

ARGCM consultation: General comments applicable for parts A, B, C and D

ARGCM consultation: General comments applicable for parts A, B, C and D
All submissions supported the revision and restructure of the ARGCM. A number of submissions requested further consultation on the final document.
TGA response: Comments can be made on any part of the document via the TGA website. Further revision will occur as required.
Submissions advised of minor typographical changes, minor corrections and requested that plain English be used. Further, duplication of information should be reduced; active voice be used in preference to passive voice; and more hyperlinks to other information/sites be provided.
TGA response: The ARGCM has been revised taking the above points into consideration.
Industry submissions requested an executive summary and a change log.

TGA response: As the revised ARGCM is a complete rewrite of the original ARGCM, the provision of a change log would be lengthy, resource intensive and impractical. However, any future changes to the final document will be indicated on the website.

The ARGCM is presented in web format and is readily searchable. Providing a lengthy executive summary would duplicate information on the website.

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ARGCM Part A: General guidance consultation submission comments

ARGCM Part A: General guidance consultation submission comments
Preparations should be implemented without industry consultation.
TGA response: The revised ARGCM provides clarity on homoeopathic definitions, exemptions, labelling and GMP requirements and is reflective of the current legislative framework.
Industry/ non-industry submissions questioned the status of the 2008 consultation: Revised Regulatory Options for Homeopathic Medicines.
TGA response: The 2008 consultation was undertaken in the context of a proposed joint Australian and New Zealand regulatory framework for homoeopathic medicines. Consultation on ANZTPA will be undertaken in 2014.
Extemporaneously compounded medicines An industry submission suggests the inclusion of naturopaths and nutritionists when specifying health professionals.
TGA response: Exemptions for healthcare practitioners have been clarified.
Exemptions for advertising directed to practitioners Industry submissions request information on the role of the industry associations in the advertising regulatory process and clarification of exemptions for advertising directed to practitioners.
TGA response: The revised ARGCM provides clarity on these issues and provides relevant links to industry associations.
Incidental minor excipients Industry submissions suggest that information on Incidental Minor Excipients (IMEs) be divided into raw materials and manufacturing process requirements. Further, the term 'insignificant' with respect to the quantity of IMEs should be quantified. Advice on how the TGA will consider any proposed new IMEs should be provided.
TGA response: The guidance for IMEs has been developed in consultation with industry representatives via the 'Office of Complementary Medicines/Industry Consultation Group', at which time the above issues were considered. The revised ARGCM reflects current practice.
Grandfathered product Non-industry submissions state that grandfathered products should be subject to the same review process as new products.
TGA response: The TGA's framework for conducting compliance reviews of listed complementary medicines is available on the website.
Proprietary Ingredients and active pre-mixes Industry submissions requested clarification on issues relating to proprietary ingredients.
TGA response: The revised ARGCM provides clarification on: notifications; GMP requirements; active and excipient ingredients; information held by the TGA; and when manufacture is considered a step in the manufacturing process.
Traditional medicines An industry submission asks how solvents used in traditional preparations (e.g. milk, wine) can be added to the permitted solvents list.
TGA response: This is beyond the scope of the ARGCM consultation. However, such requests would be considered on a case by case basis.
'Note for guidance on quality of herbal medicinal products' permits fermentation in the preparation of herbal extracts. An industry submission questions that, as this guideline has been adopted by the TGA, if fermentation is permitted for herbal substance preparations?
TGA response: The current definition for a herbal substance included in the Regulations does not include a fermentation manufacturing step. Such ingredients would require evaluation to be permitted for use in listed medicines.
Post listing compliance Industry submissions request clarification on a sponsor's rights of appeal.
TGA response: The revised ARGCM clarifies appeal mechanisms.
Non-industry submissions recommend that the information requested in a targeted review be submitted at time of lodgement and greater penalties for non-compliance be imposed.
TGA response: This represents policy change and is beyond the scope of the ARGCM consultation.

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ARGCM Part B: Listed medicines consultation submission comments

ARGCM Part B: Listed medicines consultation submission comments
Indications/claims Industry submissions request clarity on the terms 'indications' and 'claims'.
TGA response: The revised ARGCM provides an explanation of the terms 'indications' and 'claims'.
Evidence for listed medicines Industry submissions state that the new 'Evidence Requirements' document has not been implemented and should not be referred to.
TGA response: The ARGCM clarifies that until the revised evidence guidance document is in effect the current guidelines apply.
In relation to evidence for listed medicines, non-industry submissions request that there be more information available to consumers, stricter requirements and greater penalties for breaches. In addition, the TGA should undertake an independent analysis of products.
TGA response: These comments are beyond the scope of the ARGCM review.
Listing process via the electronic listing facility Industry submissions request clarification on the steps for listing a medicine.
TGA response: The revised ARGCM provides clarity on the listing process and refers readers to the new user guide.
Quantified by input (QBI) Industry requests that issues raised during the 2009 quantified by input (QBI) consultation be addressed, including: clarification of: QBI for excipient and active ingredients, restricted ingredients, rotational testing, sponsor responsibilities, etc.
TGA response: All industry comments have been considered and the guidance on QBI reviewed. Note that flow charts and 'questions and answers' have intentionally been removed from the document as it was apparent from submissions that these created confusion.
Changes to complementary medicine Industry submissions request clear guidance on the different types of changes for complementary medicines.
TGA response: The types of changes for complementary medicines have been clarified in the revised ARGCM.

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ARGCM Part C: New complementary medicine substances submission comments

ARGCM Part C: New complementary medicine substances submission comments
Introduction Industry submission questions if the term 'switch' substance is still being used?
TGA response: 'Switch' substance is not a term included in the legislation and is not used in the revised ARGCM.
Electronic submissions and Common Technical Document (CTD) Industry submissions request guidance on electronic submissions and suggest that the CTD reference numbers be provided.
TGA response: If applicants choose to present their dossier in the CTD format, it can be numbered accordingly. However, in recognition that not all parts of the CTD are relevant, the ARGCM lists the information required in an application - these are not numbered.
Evaluation process Industry submissions request clarification on decision points; timeframes; appeal rights and data requirements.
TGA response: The above points have been clarified in the revised ARGCM.
Industry submissions state that quality and safety are the only considerations in the evaluation of listable ingredients. While non-industry submissions state that it is crucial that efficacy be evaluated, with only evidence-based and robust studies accepted in support of an application.
TGA response: Data requirements have been clarified in the revised ARGCM. Proposals for change in policy are outside the scope of the ARGCM consultation.
Compositional guideline Industry submissions request clarification of data requirements and question the consultation process for compositional guidelines.
TGA response: The requirements for compositional guidelines have been clarified in the revised ARGCM. Changes to the review and consultation process for compositional guidelines are beyond the scope of the ARGCM review.

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ARGCM Part D: Registered medicines consultation submission comments

ARGCM Part D: Registered medicines consultation submission comments
General An industry submission notes that there is no provision for 'clone' medicines.
TGA response: Applications for 'clone' medicines are not common for registered complementary medicines. If such a situation arises, the evaluation process would be consistent with the approach taken in other business areas of the TGA.
Industry submissions state that there is no consideration of risk-based treatment of products. There is considerable difference between a multivitamin-mineral supplement and a medicine containing a new nutrient derivative without a history of use.
TGA response: The requirements for different types of applications have been clarified in the revised ARGCM.
An industry submission suggests it should be possible to gain provisional approval of a substance for use in registered complementary medicines before the substance is included in a product.
TGA response: The ARGCM emphasises the need for a pre-submission meetings, at which times these types of issues would be addressed.
CTD format and data requirements Industry submissions state that it should not be necessary to provide a justification for every non-applicable CTD section; rather, justification should be required only where data would normally be provided.
TGA response: A justification must be provided where relevant data are not provided.
Literature based submissions Industry submissions request guidance on literature based submissions and request a list of approved reference texts be provided.
TGA response: The ARGCM provides a link to the Australian Regulatory Guidelines for Over the Counter Medicines (ARGOM) for literature based submissions. However, as the relevance of reference texts to a medicine must be considered on a case by case basis, a list of 'approved' texts is not considered appropriate.
Timeframes and requests for information Industry submissions request timeframes for each application phase for a new registered complementary medicine be established.
TGA response: Implementation of set timeframes forms part of a larger review of the processes associated with applications for new registered complementary medicines. While such a review would be in-line with recent reviews of other registered medicine business processes, it is beyond the scope of the ARGCM review.
Industry submissions state that TGA requests for information should be consolidated for the applicant, reducing the number of requests.
TGA response: The evaluation process aims to be as efficient and streamlined as possible and, in general, requests for information are consolidated. However, in some instances, separate requests relating to (for instance) quality and safety may be made - particularly when specifically sought by the applicant. Limiting the number of requests for information would form part of a broader review of the business processes associated with new registered complementary medicines and is beyond the scope of the ARGCM review.
Prescription complementary medicines An industry submission questions why there is no mention of the evaluation process for prescription complementary medicines.
TGA response: The evaluation of prescription medicines is described in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM).
Screening process and "not effective" submissions. Industry submissions suggest that there should be an option for an application to be considered 'pending' and the sponsor given opportunity to address minor deficiencies.
TGA response: The revised ARGCM provides clarity on the application process.
Appeal mechanisms An industry submission contends that a decision that an application is 'not effective' is reviewable under section 60.
TGA response: There is no appeal provision under section 60 of the Act for applications that are considered ‘not effective’. However, where an application is accepted for evaluation, the final decision on the registration is appealable.
Product and Consumer Medicine Information A non-industry submission states that Consumer Medicine Information (CMI) should be available for all registered medicines.
TGA response: The revised ARGCM clarifies the medicines for which CMIs and PIs are mandatory.
Data requirements Non-industry submissions state that data on efficacy should consist of high quality scientific studies only and traditional use should not be considered. All clinical studies should be in the public domain. A similar document to the Australian Public Assessment Reports for prescription medicines (AusPARs) should be implemented.
TGA response: This is beyond the scope of the ARGCM review.
Labelling Industry comments that the ARGCM should not provide information available in the labelling order (TGO 69). Rather, guidance should be provided on such things as graphics, logos, symbols, reference to other products, advisory statements.
TGA response: Information on labelling has been consolidated and clarified in the revised ARGCM.
Dose measuring devices Industry submissions state that measuring devices are not medical devices with a therapeutic function and are not marketed separately.
TGA response: Some measuring devices may be considered Class 1 medical devices.
Modified release Industry submissions state that the requirements for modified release are excessive and costly. For a 'modified release' the standard dissolution test should be sufficient supporting data to demonstrate the controlled release claim.
TGA response: If a medicine claims to be ‘modified release’ it must have sufficient supportive data for the claim.
Changes to registered medicines An industry submission asks why the same rules and change codes used for registered over the counter medicines (OTC) do not apply to registered complementary medicines.
TGA response: The legislative basis for changes to registered OTC medicines and registered complementary medicines are the same. However, a recent business review for OTC medicines has resulted in a number of changes to processes which are not applicable to registered complementary medicines, given they were not in scope of the review.

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