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.