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Public Consultation: Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.

Yasir Mahmood Invitation for Comments , ,

The Drug Regulatory Authority of Pakistan (DRAP), Division of Biological Evaluation & Research, invites public comments on the draft “Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.”

This updated guidance aims to enhance clarity, align regulatory requirements with international standards, and introduce specific provisions for biosimilars, bulk/ready-to-fill biologicals, pharmacovigilance, stability, and comparability requirements. The document is intended to facilitate consistent, transparent, and efficient submission and review of registration applications for biological products.

Stakeholders, including manufacturers, importers, healthcare professionals, academia, and the general public, are encouraged to review the draft and submit written comments, suggestions, or technical inputs at muneeb.cheema∂dra.gov.pk or muneebcheema∂hotmail.com within fifteen days of uploading of above document.

Guidance-Document-Biological-Edition-2Download

National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products

Asad Ullah Drugs

The regulation of lot release is an integral regulatory control to ensure the quality and safety of biological products. Its purpose is to verify that each batch/lot of the product meets the stipulated standards of manufacturing and quality control. The National Control Laboratory for Biologicals (NCLB), Islamabad assumes the responsibility of overseeing lot release function through reviewing the manufacturer’s protocol, analytical methods and summary protocol, and also conduct analytical testing if necessary. This is aimed at assuring that every product batch/lot that enters the market adheres to the approved specifications at the time of registration, including any post-registration modifications or variations. The primary objective is to safeguard the public from substandard product batches/lot.

The National Control Laboratories for Biologicals, DRAP has published guideline on the procedural requirement for lot release of biological products. This guidance document was drafted and uploaded in May 2023 seeking comments from stakeholders. It provides an overview of the lot release process how the procedure is established and what products are covered under the lot release system.

Guideline for lot release of biological drugsDownload