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SFDA - Guidelines for Variation Requirements

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements".

These guidelines are adopted from the EMA Guidelines on the details of the various categories of variations, Regulation (EC).

This document applies to change(s) made to drug products that have already received marketing authorization by Saudi Food & Drug Authority (SFDA).

The objective is to classify variations and to provide applicants with recommendations on the data required for each type of variation; which may impact the safety, efficacy, and quality of drug products.

It is important to note that the authority reserves the right to request any additional information and data not specifically described in this document, in order to assess adequately the safety, efficacy, and quality of drug products. Authority is committed to ensuring that such requests are justifiable and decisions are clearly documented.

Applicants should be aware that deficient documentation can lead to the rejection of the application. In addition, submitting redundant or irrelevant information may delay approval procedures.

Click on the LINK to know more about this guideline and its types of variations etc.


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