ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has directed the local pharmaceutical industry and drug importers to comply with the second edition of post-registration variation guidelines.
In a letter directed to the Pakistan Pharmaceutical Manufacturing Association (PPMA), Pakistan Chemist and Druggist Association (PCDA) and Pakistan Pharmaceutical Manufac-turers and Importer (PPMI), the regulator has said, “it has been observed that variation applications are not being submitted on the prescribed “Form” and as per documentation requirement provided against each variation”.
The regulator further said that the Post Registration Variation Guidelines (2nd Edition) for pharmaceutical and biological drug products were posted on the official website of DRAP on 01.10.2023.
In the aforesaid guidelines, the pharmaceutical companies, manufacturers and importers were advised to submit the application of variations of their registered drugs on the given “Form” along with the documentation requirements as laid down in these guidelines.
“It is; therefore, requested to advise your member companies to comply with the requirements and procedures laid down in the Post Registration Variation Guidelines 2nd Edition. The variation applications submitted without a filled Form and in complete documentation shall not be entertained in future.”
DRAP in 2023 finalised the second edition of its guidelines on procedure and data requirements for post-registration variation of drugs. Registration/ marketing authorisation 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 are intended to provide information for the 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.
These guidelines will assist both regulators and industry on the regulation of variation/ changes to the original registrations/ market authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed/ intended change on the quality, safety and efficacy of the locally manufactured/imported finished pharmaceutical and biological drug products intended for human and veterinary use.
These guidelines are intended to provide supportive information for submission of post-registration variation application by the registrations/ marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.
Copyright Business Recorder, 2024