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Generic registered complementary medicines
ARGCM Part D: Registered complementary medicines
This guidance is to assist applicants to register a generic complementary medicine on the ARTG.
Quality data is required in support of generic complementary medicines to ensure:
- consistency and quality of the manufacturing process for the medicine
- the quality of the ingredients and the final product
- the combination of ingredients used to make the final medicine product.
In most cases you do not need to provide safety data in support of generic complementary medicines. However, in most cases you need to provide efficacy data (bioequivalence or therapeutic equivalence data) to demonstrate bioequivalence with the originator medicine.
Applications for new generic complementary medicines can be one of two application categories:
- RCM 3: generic complementary medicines for which you can provide an appropriate scientific justification for not providing bioequivalence data
- RCM 4: generic complementary medicines when bioequivalence studies are necessary
When bioequivalence data is required
Bioequivalence date is required:
- for all generic modified release dose forms (excluding enteric-coated tablets or capsules)
- if there is reason to believe that the bioavailability of the proposed medicine may differ from the originator medicine, which may adversely impact on efficacy and/or safety of the medicine
- For example, if the medicine contains excipient(s) or has novel properties that could significantly affect gastric passage, absorption, in vivo solubility or in vivo stability of the active substance
Requirements for bioequivalence data
Include biopharmaceutic study reports in module 5.3.1 and complete the Summary of a Bioavailability or Bioequivalence Study form for each study and include in module 1.9.1 of the dossier.
When bioequivalence data is not required
There may be cases where a justification for not providing bioequivalence data is appropriate. These should be discussed at a pre-submission meeting. In your justification:
- include an explanation as to why the requirement is not being met
- detail the proposed alternative approach and a scientific justification for why the proposed approach is valid (with reference to any supporting documents)
Include your justifications for not providing bioequivalence data in Module 1.9.2 of the dossier.
Refer to Biopharmaceutic studies guidance, section 15.9 for more information on what to include in the justification.
- ARGPM guidance 15: Biopharmaceutic studies
- Guideline in the investigation of bioequivalence
- Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms – section 6, abridged application for modified release forms refer to a marketed modified release form
- CTD Module 5: Efficacy (clinical study reports) - section 2.7.1 and 5.3.1 provide information on bioequivalence.