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Application categories

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ARGCM Part D: Registered complementary medicines

29 October 2017

This guidance provides descriptions and examples of the five categories for registered complementary medicines applications. If your proposed application is not captured by an example, determine the appropriate application category by considering the data requirements for quality, safety and efficacy, which are submitted in Module 3 (quality), Module 4 (nonclinical) and Module 5 (clinical). Please refer to Common Technical document (CTD) for further information on the modules.

As part of the Government's complementary medicine reforms, TGA will be consulting on application category types for registered complementary medicines in late 2017.

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Category 1 (RCM 1)

For complementary medicines that are identical to a fully evaluated registered complementary medicine (the originator medicine[5]) other than its name, colour, flavour and/or fragrance.

  • Originator medicines must be registered on the ARTG and have been fully evaluated for safety, quality and efficacy (cannot be a 'grandfathered' medicine). If in doubt, check the list of evaluated registered complementary medicines.
  • Label, indications and formulation must reflect the fully evaluated originator medicine.
  • Originator medicines must comply with current requirements including RASML, the Poisons Standard, relevant Therapeutic Goods Orders (e.g. TGO 69, TGO 77, TGO 78, TGO 80, TGO 92) and default pharmacopoeial standards.
  • The sponsor of the originator medicine must authorise the TGA to access the information on the originator medicine files and ARTG record for the purpose of the RCM 1 application.

Although the 'Permitted differences for the parent medicine' provides guidance for OTC medicines and refers to a 'parent' medicine rather than an 'originator' medicine, the guidance also applies to RCM1 application.

RCM 1 applications have reduced requirements for supporting data as the proposed medicine is almost identical to an originator medicine. However, adequate data and/or justification to support any permitted differences between the proposed and originator medicine must be provided.

You need to provide Module 1: registered complementary medicines including:

  • a letter of authorisation from the sponsor of the originator medicine to access the medicine information under 'Letters of authorisation' (1.5.5)
  • assurance that all quality aspects of the proposed medicine are identical to the originator medicine, other than differences that are specifically permitted (as listed in the permitted differences guidance) under 'Assurances' (1.5.7).

Additionally, if the proposed product includes a new flavour, fragrance or printing ink, you need to provide:

Module 3 (quality):

  • the proposed specifications and details of the test methods for the new flavour/fragrance/colours(s) under 'control of excipients' (3.2.P.4).

Footnote

  1. An originator medicine (sometimes referred to as the 'innovator' or 'parent' medicine) is one that has been approved for marketing in Australia following the evaluation of a full dossier.

Category 2 (RCM 2)

For complementary medicines that comply with a TGA complementary medicine monograph.

There are no TGA complementary medicine monographs available at the time of writing.

Module 1: registered complementary medicines including a letter of assurance the medicine meets a TGA complementary medicine monograph under 'Assurances' (1.5.7).

Category 3 (RCM 3)

For complementary medicines where previous evaluation by the TGA or a comparable regulatory authority (CRA) has demonstrated their safety and efficacy. Applications in this category include:

  • generic complementary medicine
  • medicine evaluated by a comparable regulatory authority.

In comparison to the fully evaluated (not grandfathered) originator medicine, the proposed generic medicine must have the same:

  • amount of active ingredient with similar quality
  • pharmaceutical form and be appropriately justified to be therapeutically equivalent through the use of bioequivalence data
  • safety and efficacy properties.

Conditions

  • Any justification for not providing bioequivalence data must meet the conditions described in the guidance for Generic registered complementary medicines.
  • The safety and efficacy data provided with the originator medicine must not be 'protected' (refer to Section 25A of the Therapeutic Goods Act 1989).

NOTE: Generic complementary medicines applications that require submission of bioequivalence data will be RCM 4.

Provide full safety and efficacy evaluation reports (in English) from the CRA, and information on relevant quality assessment of all active ingredients (or the proposed medicine).

The definition of a comparable regulatory authority (CRA) is under consideration at the time of writing.

Further considerations

  • Reports must be complete, unredacted and included in Module 1: registered complementary medicines under 'Foreign evaluation reports' (1.11.4). To meet the evidence requirements the TGA will accept multiple evaluation reports on the proposed medicine. For example one report may cover all safety aspects, excluding genotoxicity studies, but a separate report from another CRA on the same product may cover genotoxicity and efficacy data.
  • Evidence submitted to and reviewed by the CRA must be equivalent to the evidence requirements for Module 4 (nonclinical) and Module 5 (clinical).
  • There must be no new indications proposed beyond what the report considered.
  • The proposed medicine formulation must be the same as the medicine considered in the reports (formulation changes for fragrance, flavour and colouring variants are permitted).

Conditions

  • A full Module 3 (quality) dossier must be provided, even if quality has been considered in the evaluation report(s).
  • There must be no new contradictory clinical data available beyond what the evaluation report has considered.
  • No contrary regulatory evaluation reports must exist.
  • An application for the proposed medicine must not have been withdrawn in response to technical questions from a regulator or rejected in any other jurisdiction.

Please arrange a pre-submission meeting prior to submission to discuss the suitability of the evaluation reports.

  • Module 1 (complementary medicines)
  • Module 3 (quality)

NOTE: Complementary medicines using active ingredients permitted for use in listed medicines with higher level indications will be either RCM 4 or RCM 5, depending on the data requirements.

Category 4 (RCM 4)

For complementary medicines where one of quality, safety or efficacy has been established.

For all RCM 4 applications, submit Modules 1 and 2. Submit the relevant technical modules out of Module 3 (quality), Module 4 (nonclinical) and Module 5 (clinical). For more information about the modules see Common Technical document (CTD).

Examples of application category RCM4 are included in the tables below. Please note that these tables are not extensive and sponsors should seek advice from the TGA if required.

Examples of application category RCM 4 requiring Module 4 and/or Module 5
Example of RCM 4 Further considerations Conditions
New therapeutic indication Only if grouping does not apply. If grouping applies, refer to the registered complementary medicines changes tables. Must not result in a change in the target population
Wider target population A reduction in the class of person for whom the goods are suitable is considered a C1 change (change code GDS) -
Decrease in the strength Determined per dosage unit -
New directions for use For example, change in recommended daily dose Only if grouping does not apply. If grouping applies, refer to the registered complementary medicines changes tables.
Medicines requiring a PI and CMI Applications requiring a PI and CMI are considered RCM 4 or RCM 5 applications; as a minimum Module 4 and Module 5 data are required -
Examples of application category RCM 4 requiring Module 3 and Module 5
Example of RCM 4 Further considerations
Generic medicine application requiring bioequivalence data Excluding enteric-coated tablets and capsules. Further information is provided in the Generic complementary medicine guidance)
Generic modified-release dose forms Excluding enteric-coated tablets and capsules
Deletion of an active ingredient -
RCMs using active ingredients permitted for use in listed medicines with higher level indications -

A combination of RCM 4 applications may result in an RCM 5 application due to the increased data requirements (quality, safety and efficacy).

Category 5 (RCM 5)

For new complementary medicines to be registered on the ARTG that have not been previously evaluated for quality, safety and efficacy. Application examples include:

  • new registered complementary medicine - where no aspect have been previously evaluated
  • new active ingredient
  • increase in the strength of an active ingredient
  • new dosage form (as defined in TGA approved terminology for medicines)
  • addition of an excipient not currently in use in complementary medicine
  • contains a greater amount of an excipient

A complete Common Technical document (CTD):

  • Module 1 (complementary medicines)
  • Module 2
  • Module 3
  • Module 4
  • Module 5.