For comments within 10 days.
Author: Yasir Mahmood
Draft guidelines for establishment of Pharmaceutical unit and Post license variations
Minutes of the 319th Meeting of the Central Licensing Board
Notification of Draft Amendments in the Drugs (Research) Rules, 1978
The comments of stakeholders are invited on the proposed amendments in the Drugs (Research) Rules, 1978. Comments or suggestions may be forwarded to the Drug Regulatory Authority of Pakistan for consideration within seven days of the publication of the notification, either by post or by email at director.legal∂dra.gov.pk
Possible Interruption in E-Services due to Internet disruption
Due to unavoidable issues in internet services, you may face trouble or unavailability of online systems until the issue is resolved.
Implementation of Online System for Appellate Board Appeals
Expression of Interest (Hiring of Legal Consultant)
Career Opportunities in Drug Regulatory Authority of Pakistan
Applications are invited from citizens of Pakistan fulfilling the given conditions for appointment against the following positions in the Drug Regulatory Authority of Pakistan (DRAP). The details of requisite qualification, experience, age limit and regional/provincial quota and application procedure are given in following document:- (Syllabus is also given at the end)
Syllabus:
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.
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.