Regulatory Updates
Request for revision of shelf life criteria for importing innovator product’s sample
Notification regarding Therapeutic Goods (Advertisement) Rules, 2025
Annual Schedule for the CSC Meetings for the year 2025
The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.
The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2025 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.
| S. No. | CSC Meeting | Proposed Date |
| 01 | 54th CSC Meeting | 28th – 31st January 2025 |
| 02 | 55th CSC Meeting | 03rd – 08th March 2025 |
| 03 | 56th CSC Meeting | 21st – 25th April 2025 |
| 04 | 57th CSC Meeting | 26th – 31st May 2025 |
| 05 | 58th CSC Meeting | 07th – 11th July 2025 |
| 06 | 59th CSC Meeting | 25th – 29th August 2025 |
| 07 | 60th CSC Meeting | 01st – 03rd October 2025 |
| 08 | 61st CSC Meeting | 08th – 12th December 2025 |
Tender for supply of lab equipment
FIFO lists of applications received for enlistment of Herbal, Homeo , Neutraceutical products (Year 2024)
DISCLAIMER
“The FIFO list for year 2024 of alternative medicines and health products is prepared with due diligence for transparency of process and visibility of the stakeholders. However, errors and omissions may be accepted subject to valid evidence.”
Herbal
Homeo
Neutra
Provisional FIFO lists of applications received for provisional enlistment of Herbal, Homeo,Neutraceutical products (1st January, 2024 to 30th September, 2024).
Approved Content Weightages for Drug Regulatory Authority Government of Pakistan Adv.No.01/2024
Approved Content Weightages for Drug Regulatory Authority Government of Pakistan Adv.No.02/2024
DRAP Newsletter: Volume 03-Issue -II, November, 2024
The Drug Regulatory Authority of Pakistan (DRAP) has released a new issue of its quarterly newsletter, featuring several key updates and initiatives. DRAP has extended the scope of its Industry E-Reporting System for Adverse Drug Reactions to all registration holders, following a successful pilot project. The newsletter details recent actions on the promotion of clinical trials regulatory oversight, the stakeholder queries management system, and interprovincial coordination for the implementation of the Institutional Development Plan as per WHO recommendations. Additionally, the newsletter covers ongoing efforts to enhance public health and safety, including increased surveillance and regulatory actions to ensure the quality and safety of therapeutic goods.