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OTC medicines: guidelines and processes update 2013: Information for industry

22 March 2013

On 15 April 2013, the TGA and Medsafe will introduce new administrative processes for the evaluation of new and changed over the counter medicines. These reforms introduce more predictability for companies wishing to supply OTC medicines in Australia and New Zealand. This is because:

  • Risk categories for OTC medicine applications have been established;
  • Application requirements, business processes and target timeframes have been defined for each application category;
  • Product specific data requirements for well-known active ingredients are being developed; and
  • The application format has been standardised.

Taken as a whole, these measures will enable streamlining of the internal administrative practices of the TGA and Medsafe, and result in shorter and more predictable times to market for OTC medicines. These measures will be introduced without compromising the level of scrutiny applied to ensure OTC medicines meet the standards expected by consumers.

The regulatory guidelines have been updated by each regulator in Australia and New Zealand to reflect these changes.

These reforms are being implemented following extensive consultation with the Australian and New Zealand OTC medicine industry.

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The TGA and Medsafe have released separate guidance documentation prior to commencing new administrative processes to enable applicants to understand what they need to do.

A twelve month implementation phase has been established to enable applicants to become used to the new processes, and to provide feedback on their effectiveness.

The new process relates to administrative processes employed by the regulator to assess new and changed medicine applications. There are no changes to the standards applied or the assessment of the risks and benefits associated with new and changed OTC medicines.

Application dossier formats and administrative processes are common in both Australia and New Zealand from 15 April 2013. Sponsors will need to submit applications that comply with the new processes outlined in the ARGOM.

There will be a transitional period of 12 months to allow applicants to become familiar with expected formats.

Both TGA and Medsafe will implement target timeframes for the administrative steps with further review and refinement to be undertaken during a 12 month period. Both regulators will monitor and report performance against target timeframes to introduce predictability and transparency for applicants.

A review of the administrative processes will be undertaken after 18 months to ensure the reforms are delivering the predictability anticipated. The outcome of this review and any further refinement required will be reported to stakeholders.

Harmonisation of data requirements for OTC medicine applications and categorisation of changes to existing medicines will continue during the lead up to ANZTPA to enable a fully harmonised and integrated regulatory framework to commence in July 2016.

New medicines applications can be submitted in five application categories. Each application category relates to different, risk-appropriate evaluation processes.

Target timelines will apply to each of the work streams so applicants can predict completion of assessment. The administrative processes applied to an application will be standardised so that applicants will know what will happen to their applications.

One of the application categories (N2) will utilise a new approach to using product specific data as a route to approval. This will be trialled by the TGA. OTC medicine monographs (OMMs) will be available to sponsors of OTC medicines and confined to OTC medicines containing well-characterised active ingredients. The monographs will specify requirements in relation to:

  • active ingredients, dosage forms and strengths
  • indications and claims
  • directions for use
  • labelling and advisory statements
  • quality standards.

The TGA will consider developing an OTC medicine monograph for OTC medicines for which:

  • there is a high level of knowledge and experience within the TGA with the active ingredient(s) in the medicine
  • evaluation of bioavailability, bioequivalence or other clinical data is not required
  • a relevant British Pharmacopoeia/US Pharmacopoeia product monograph exists
  • the quality aspects can be sufficiently assured through sponsor assessment and assurance.

Priority for development of monographs will be given to products where the expected frequency of applications is sufficient to justify the resources involved in developing the monograph.

All relevant requirements under the Therapeutic Goods Act 1989 will continue to apply to OTC medicines, including those medicines that are covered by an OTC medicine monograph.

During the trial period further monographs will be developed to expand the number of eligible products. Medsafe will introduce monographs after 6 months trialling if initial feedback is positive.

For the TGA:

Use the same eBS submission portal as used before.

Use the guidance documents on the TGA website to:

  • determine which application category yours falls into;
  • determine the documentation required to support your claims;
  • construct your application; and
  • submit a soft copy of your dossier.

The existing fee structure will continue until further notice.

For Medsafe:

Use the application form on the Medsafe website which will be updated to include the new application categories.

Use the guidance documents on the Medsafe website to:

  • determine which application category yours falls into;
  • determine the documentation required to support your claims;
  • construct your application; and
  • submit a soft copy of your dossier.

The existing fee schedule will apply until further notice.

Yes, OTC products that comply with the old guidelines and are currently on the ARTG will still be able to be marketed.

Sponsors may also make changes to these products (e.g. changes to product names, labels or sites of manufacture). If a new entry is required, then the current process outlined in the Australian Regulatory Guidelines of OTC medicines must be applied.

eBS will be upgraded with features that provide additional support for applicants to stream applications through the submission portal. This is expected to become operational by July 2013. In the meantime the existing submission portal will continue as has been the case.

For the TGA:

The existing fee structure will continue until further notice.

It is envisaged that a new fee structure will be developed to allow for an application fee for each of the application categories, plus an evaluation fee. The evaluation fee will relate to the specific application category, rather than the current structure which involves a page count for more complex applications.

For Medsafe:

Applicants should use the existing fee schedule until further notice.