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.
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.
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 312th Meeting Of Registration Board
Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) in its various meetings have already exempted inspection of manufacturer abroad in certain scenarios.
Minutes Of 308th Meeting Of Registration Board
Minutes Of 307th Meeting Of Registration Board
Minutes of 296th Meeting of Registration Board
Minutes of 295th meeting of Registration Board
Minutes of 294th meeting of Registration Board