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DRAP Guidelines: Preparation of Summary of Product Characteristics (SmPC)

The Drug Regulatory Authority of Pakistan (DRAP) released a finalized guideline "Preparation of Summary of Product Characteristics (SmPC)".

A Summary of Product Characteristics (SmPC) provides healthcare professionals with essential information on how to use a drug product to ensure safety, efficacy, and quality, and is also used to prepare the Patient Information Leaflet (PIL).

This guideline is intended to provide supportive information for the preparation of a Summary of Product Characteristics (SmPC) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars.

The guideline detail the principles of presenting information in the SmPC. Throughout the lifecycle of a drug product, the SmPC will be updated with new data regarding its safety, efficacy, and quality.

The registration/market authorization holder shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of SmPC.

As per the guideline the applicants are advised to submit a separate SmPC for each strength and dosage form of the finished drug product in the prescribed format provided similar to Annexure-I in this guideline, under Module 1.5.14 as Summary of Product Characteristics (SmPC).


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