PER
Minutes of 361st Meeting of the Registration Board (21st August 2026)
Minutes of 357th Meeting of the Registration Board
Minutes of 360th Meeting of the Registration Board (07 July 2026)
Minutes of 359th Meeting of the Registration Board (09 June 2026)
Minutes of the 356th Meeting of Registration Board (07th April 2026)
Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing
Registration Board in its 323rd 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
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.
Minutes of 316th Meeting of Registration Board held on 15th to 18th March, 2022
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.