The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 90th meeting held on 17th June, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.
Regulatory Updates
Holding of Khuli E-Kachehri
Holding of 12th Khuli E-Kachehri.
Inspection Of Manufacturers Abroad For Registration Of Finished Drugs
Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) in its various meetings have already exempted inspection of manufacturer abroad in certain scenarios.
Notification F.No.4-2/2017-DD (H&OTC)
Notification F.No.8-3/2019-H&OTC
Guidelines for manufacturing of Alternative Medicines, Health Products and Probiotic by the DML holders.
Conduct Of Clinical Trials Guidelines (v2.0) Stake holders are invited for comments to be submitted within 15 days to email: drap.pharmacy@gmail.com
List Of Required Sops At BA/BE Studies Center
Process Flow of Clinical Trials
Online Submission of Licence Application of Medical Devices
Deficiency Letter of All Deferred Products In 94th Meeting Of EEC Held On 26-08-2021 [13 Dec, 2021]
The applications of following applicants were placed before the Enlistment Evaluation
Committee (EEC) in its 94th meeting held on 26th August, 2021 and the same have been deferred being deficient
of the information / documents as specified in column (3) of the Table below which may be furnished within
20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at
the end of this letter/document. Replies received after given time will not be entertained: