Decision of 124th MDB Meeting
Decision of 125th MDB Meeting
Decision of 126th MDB Meeting
Decision of 127th MDB Meeting
Regulatory Updates
Directive on the security of online portals and engagement with authorized personnel/consultants
The Drug Regulatory Authority of Pakistan (DRAP) is striving to fulfill its mission of ensuring the availability of safe, effective, and quality therapeutic goods through a transparent and efficient regulatory framework. In line with the Government’s “Digital Pakistan” vision, DRAP has successfully digitized all regulatory functions related to pharmaceuticals, biological drugs, and medical devices, streamlining processes to foster an environment conducive to the ease of doing business. The Alternative Medicine & Health Products online system will also be launched soon.
To facilitate stakeholders in navigating these digital advancements, the following key initiatives and directives are brought to your immediate attention:
- Comprehensive video tutorials and step-by-step user guides are available on the official DRAP website to assist stakeholders/applicants in navigating these online portals.
- To ensure clarity and regulatory predictability, DRAP has published detailed guidelines for various regulatory processes, ensuring that requirements are transparent and accessible to all.
- A Case Management System has been launched to streamline regulatory correspondence and planning of regulatory interactions, when required.
While DRAP has made every effort to simplify the regulatory interface, it has been observed that some stakeholders continue to rely on third-party consultancy services for processing their applications. DRAP strongly discourages the direct engagement of unauthorized consultants. Stakeholders are advised that the use of intermediaries can lead to complications regarding accountability and data integrity.
To safeguard your legitimate rights and business interests, please adhere to the following security protocols:
- Ensure that all login credentials for DRAP’s online platforms are kept secure and under the direct control of your authorized company personnel.
- Strictly limit or restrict access of outside consultants to your digital portals to prevent unauthorized data manipulation or privacy breaches.
- Regularly visit DRAP’s official website for regulatory updates and notifications.
The digitization of DRAP is intended to empower stakeholders by providing a direct and transparent link to the regulator. DRAP is actively collaborating with trade associations and health partners to conduct specialized training sessions. These programs are designed to promote a culture of compliance across the industry and to gather direct user feedback to continuously refine and improve the online systems. DRAP remains your partner in progress, committed to continuous improvement through direct engagement and technological innovation.
Circular for Implementation Plan of PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part-l
Requirements for Grant Of Drug Manufacturing License by the Way of Basic & Semi-Basic Manufacturing for Blood/ Plasma Establishments
Notification (S.R.O. 515(l)/2026)
Draft Therapeutic Goods (Import and Export) Rules 2026 (For Comments)
Note:- “comments may be forwarded to the Authority either through email at director.legal∂dra.gov.pk or by post to the official postal address of DRAP within fourteen days of the publication of the Notification.”
Training session for medical device stakeholders on the MDMC licensing and product registration portal
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.