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Regulatory Updates

Annual Schedule for the CSC Meetings for the year 2025

Yasir Mahmood Clinical Trials

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 MeetingProposed Date
0154th CSC Meeting28th – 31st January 2025
0255th CSC Meeting03rd – 08th March 2025
0356th CSC Meeting21st – 25th April 2025
0457th CSC Meeting26th – 31st May 2025
0558th CSC Meeting07th – 11th July 2025
0659th CSC Meeting25th – 29th August 2025
0760th CSC Meeting01st – 03rd October 2025
0861st CSC Meeting08th – 12th December 2025
1.-Annual-Tentative-Plan-for-CSC-MeetingDownload

FIFO lists of applications received for enlistment of Herbal, Homeo ,  Neutraceutical  products (Year 2024)

Ijaz Mustafa Alternative Medicines, General

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

Herbal-ProductsDownload

Homeo

Homeo-ProductsDownload

Neutra

Neutra-ProdcutsDownload

DRAP Newsletter: Volume 03-Issue -II, November, 2024

Asad Ullah General, Regulatory Updates

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.

DRAP_NewsLtter_Nov2024Download

Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

Asad Ullah Drugs, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Implemenation letter of Industry e-reporting systemDownload