DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle. These guidelines retain the essentials of the previously published guidelines and have been extended with new terminology of types of variations and documentation required to support a specific change.
This guideline is intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.
This guidance document is applicable to APIs and excipients manufactured by chemical synthesis or semi-synthetic processes and biological processes and the drug products containing such APIs & excipients.
These draft guidelines on post registration variation were uploaded on the official website of DRAP on 4th July, 2023, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to muneeb.cheema∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmaceutical Evaluation & Registration 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.