PER – Drug Regulatory Authority of Pakistan

Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing

Asad Ullah Drugs, Notifications, Regulatory Updates February 7, 2023February 7, 2023Drugs, Notifications, PER, Registration

Registration Board in its 323^rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”

Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:

“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”

Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.

Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data

Asad Ullah Drugs, Notifications, Regulatory Updates October 17, 2022October 17, 2022Notifications, PER

Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).

The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.

Notification-Form-5 Download

Minutes of 316th Meeting of Registration Board held on 15th to 18th March, 2022

Yasir Mahmood Registration Board May 14, 2022October 28, 2022PER

The Drug Registration Board convened its 316th meeting from 16th to 18th March, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.

Minutes-of-316th-meeting-of-Registration-Board Download

Minutes Of 312th Meeting Of Registration Board Held On 14-16th September, 2021.

Murtaza Awan Registration Board September 14, 2021January 13, 2022PER

Minutes Of 312th Meeting Of Registration Board

PDF File Download

Inspection Of Manufacturers Abroad For Registration Of Finished Drugs

Murtaza Awan Drugs September 10, 2021December 29, 2021PER

Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) in its various meetings have already exempted inspection of manufacturer abroad in certain scenarios.

Mfg-abroad Download