Regulatory Updates
Public Consultation: Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.
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.
Invitation for Stakeholders’ Comments on Draft Amendments in the Bio-Study Rules, 2017
The Bio-Study Rules, 2017, notified vide S.R.O. 697(I)/2018 dated 05 June 2018, provide the regulatory framework for the conduct, oversight, and approval of clinical research in Pakistan. These Rules govern Clinical Trials and Bioavailability/Bioequivalence (BA/BE) studies, as well as the licensing and regulation of Clinical Trial Sites/Centres, Contract Research Organizations (CROs), BA/BE Study Centres, and Bioanalytical Laboratories.
Since the promulgation of the Bio-Study Rules, 2017, significant advancements have taken place in international regulatory science, including revisions to the ICH-GCP guidelines, WHO Global Benchmarking Tool (WHO-GBT) recommendations, and regulatory practices adopted by reference regulatory authorities. In parallel, regulatory and operational experience gained during implementation of the Rules has highlighted the need to further streamline regulatory processes and reduce approval timelines, while ensuring continued compliance with ethical standards, subject safety, and data integrity.
In view of the above, draft amendments are proposed to selected provisions of the Bio-Study Rules, 2017 with the following key objectives:
i. Alignment with International Standards:
- To harmonize the Rules with the latest ICH-GCP guidelines, WHO-GBT recommendations, and other internationally recognized regulatory standards.
- To ensure consistency in terminology, definitions, and regulatory expectations in line with global best practices.
ii. Reduction of Approval Timelines:
- To enhance regulatory efficiency by minimizing procedural delays without compromising participant safety, scientific rigor, or ethical oversight.
iii. Clarity in responsibilities of CSC/Chairman CSC:
- To clearly designate and rationalize the roles, responsibilities, and decision-making powers of the Clinical Studies Committee (CSC) and the Director, Pharmacy Services / Chairman, CSC.
- To empower the Director, Pharmacy Services / Chairman, CSC, to grant registration of Phase-IV Clinical Trials and BA/BE Studies, and to take regulatory decisions in clearly defined categories (including administrative matters, low-risk amendments, clarifications, and routine extensions), while reserving policy-level, complex, or high-risk matters for consideration and approval by the CSC.
iv. Composition and Notification of the CSC:
- To enhance the number of expert members in the CSC in order to optimally utilize multidisciplinary expertise for effective oversight of Clinical Trials and BA/BE studies.
- Notification of the CSC by the Authority to ensure continuity and uninterrupted operational functioning of the Committee.
The proposed amendments are expected to:
- enhance regulatory predictability, clarity, and transparency;
- reduce unnecessary administrative burden and approval timelines;
- facilitate risk-based, proportionate, and efficient regulatory decision-making; and
- strengthen Pakistan’s clinical research regulatory framework in alignment with international standards, thereby enhancing the country’s attractiveness for clinical research and innovation.
Invitation for Comments
All stakeholders, including sponsors, CROs, investigators, clinical trial sites, BA/BE study centres, ethics committees, academia, and other interested parties, are invited to review the draft amendments and submit their comments and suggestions or technical inputs at shafqat.hussain∂dra.gov.pk or akhtarabbas.khan∂yahoo.com within fifteen days of uploading of above document.
Capacity building and technical awareness session on 2D Barcode & Serialization and harmonized report writing performa for inspection of pharmaceutical units (Session in Peshawar)
Capacity building and technical awareness session on 2D Barcode & Serialization and harmonized report writing performa for inspection of pharmaceutical units
Requirements for Grant of Drug Manufacturing License by the Way of Basic and Semi-Basic Manufacturing for Blood/Plasma Establishments
The Drug Regulatory Authority of Pakistan has revised and updated the requirements for Establishment of pharmaceutical unit and also developed new guidance annexure VI (A) for requirements for grant of Drug manufacturing license by way of Basic and semi basic manufacturing for Blood and plasma Establishments in line with DRAP Act 2012, Drug Act 1976 and rules framed there under.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses for Blood/Plasma Establishments by way of basic/semi-basic manufacturing. The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani plasma establishments to meet the stringent standards required by international fractionators and foreign regulatory authorities.
These requirements are applicable to a broad range of entities and activities within the plasma supply chain. All Plasma Establishments that hold Drug Manufacturing Licenses and engage in the collection, testing, processing, storage, or distribution of plasma intended for fractionation must comply with these requirements. This also includes blood establishments that collect whole blood from which plasma is recovered, and plasma warehouses and distribution facilities that handle plasma after collection.
Accordingly, the 3rd version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT AND POST LICENSE CHANGES “along with newly drafted Annexure VI ( A) REQUIREMENTS FOR GRANT OF DRUG MANUFACTURING LICENSE BY THE WAY OF BASIC & SEMI-BASIC MANUFACTURING FOR BLOOD/ PLASMA ESTABLISHMENTs are uploaded on the official website of DRAP on the 29th of December , 2025 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to akbar.ali∂dra.pk and drapakbar∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.