Regulatory Updates
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.
Draft Guidance Document For Clinical Trials Of Biological Products (Manufacture Locally)
For comments of stakeholders
Notification for GCP Inspections
Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders
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.
Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)
Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).
It is hereby circulated for compliance and information of all stakeholders.