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OTC medicines - Safety and efficacy data
3 - OTC non-generic medicines
Your medicine is a non-generic if it includes new:
- active ingredients (new chemical entity or NCE)
- active ingredient strengths
- active ingredient combinations
- dosage forms
If your medicine is based on an existing medicine that has not been fully evaluated by the TGA (i.e. 'grandfathered'), it is likely to require data as for non-generic medicines. Contact OTC Medicines if you are unsure.
For non-generic medicines you will need to provide data to support efficacy and safety. Data requirements will vary depending on the nature of your proposed medicine. Refer to the following guidance, as relevant:
- TGA medicines guidance
- TGA adopted EU clinical and nonclinical guidelines
- Non-generic topical (locally acting, locally applied) medicines
- Active ingredients in a new dosage form
- New fixed combination medicines
- New modified release dosage forms
Refer also to Types of data to support OTC medicine applications for guidance on the specific types of data that may be required.
If you are unsure as to the data required to support your proposed medicine, contact OTC Medicines.
3.1 Non-generic topical (locally acting, locally applied) medicines
For safety and efficacy data requirements refer to Note for guidance on clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95 final).
3.2 Active ingredients in a new dosage form
- If your medicine contains an active ingredient that is new for the proposed dosage form, data requirements will vary depending on the nature of the application, as follows:
- If your medicine involves a new route of administration for the active ingredient, provide full clinical and non-clinical studies.
- If your medicine is a new locally-acting topical dose form for the active ingredient where others already exist (e.g. a proposed gel form of a currently registered cream), provide full clinical data and local tolerance data unless otherwise justified. Refer to Note for guidance on clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95 final).
- If your medicine is a modified release medicine, follow the guideline for new modified release dosage forms.
- If your medicine is a new immediate release oral dose form for the active ingredient where others already exist (e.g. a proposed tablet form of a registered oral suspension) and qualifies as a generic medicine, follow the guideline for OTC generic medicines. If it is not a generic medicine (e.g. different dosage or indications), provide necessary clinical and/or non-clinical data to support the safety and efficacy of the medicine.
3.3 New fixed combination medicines
Provide supporting data as described in the Guideline on Clinical Development of Fixed Combination Medicinal Products (CPMP/EWP/240/95 Rev1).
Refer to the guideline for full requirements. To assist you, we have provided the following points from the guideline:
- The combination should be based on valid therapeutic principles.
- The duration of action of the active ingredients should not differ significantly, unless the combination is clinically valid despite differences in this respect.
- Where the individual active ingredients are intended simultaneously to relieve different symptoms of a particular disease state, these symptoms should regularly occur simultaneously:
- in a clinically relevant intensity
- for a relevant period of time.
- The advantages and disadvantages of the combination and each dose of the combination need to be assessed in the justification provided.
- Each dose combination should be carefully justified and clinically relevant.
- The dosage of each active ingredient should be such that:
- the combination is safe and effective for a significant target population
- the benefit/risk assessment of the combination is equal to (or exceeds) that of each active ingredient alone.
- Each active ingredient should make a therapeutic contribution to the claimed indications. This should be demonstrated by clinical studies, unless otherwise justified.
- Data should be submitted to establish that pharmacokinetic and pharmacodynamic interactions between the active ingredients either:
- do not occur
- are clearly recognised and defined
The requirements for new fixed combination medicines also apply to new composite packs.
3.4 New modified release dosage forms
Provide supporting data as described in the Guidance on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1).