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Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs

Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for Post-Registration Variation of Drugs".

The purpose of this guideline is to provide information to registered / marketing authorized drug product holders on how to submit post-registration variation applications. It describes the categories of variations and the requirements for submitting an application for a particular variation.

The guidance document applies to APIs, excipients, and drug products containing APIs and excipients manufactured by chemical synthesis, semi-synthetic, and biological processes.

In addition, APIs, excipients, and drug products of biological or biotechnological origin may require additional documentation from the Biological Evaluation & Research Division (BE&R).

As per the guideline the variations are classified as

Minor Variation (MiV-N, MiV-PA)

Variation to a registered finished product in terms of administrative data and/or changes with minimal/no significant impact on the aspects of efficacy, quality, and safety.

Major variation (MaV)

Variation to a registered finished product that may affect significantly and/or directly the aspects of quality, safety and efficacy and it does not fall within the definition of minor variation and new registration.

The registration holder or his authorized representative shall submit the variation application in the name of the Secretary Registration Board along with a declaration letter stating that no other changes are being made.

To know more about the timelines, and the documents that are required for the variation type, click this LINK.


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