Minutes of the meetings of Clinical Studies Committee (CSC) conducted in the light of Bio Study Rules 2017

Minutes of 1st Meeting of CSC

Minutes of 2nd Meeting of CSC

Minutes of 3rd Meeting of CSC

Minutes of 4th Meeting of CSC

Minutes of 5th Meeting of CSC

Minutes of 6th Meeting of CSC

Minutes of 1st Meeting of CSC

Minutes of 8th Meeting of CSC

Minutes of 9th Meeting of CSC

Minutes of 10th Meeting of CSC

Minutes of 11th Meeting of CSC

Minutes of 12th Meeting of CSC

Minutes of 13th Meeting of CSC

Minutes of 14th Meeting of CSC

Minutes of 15th Meeting of CSC

Minutes of 16th Meeting of CSC

Minutes of 17th Meeting of CSC

Minutes of 18th Meeting of CSC

Minutes of 19th Meeting of CSC

Minutes of 20th Meeting of CSC

Minutes of 21st Meeting of CSC

Minutes of 22nd Meeting of CSC

Minutes of 23rd Meeting of CSC

Minutes of 24th Meeting of CSC

Minutes of 25th Meeting of CSC

Minutes of 26th Meeting of CSC

Minutes of 27th Meeting of CSC

Minutes of 28th Meeting of CSC

Minutes of 29th Meeting of CSC

Minutes of 30th Meeting of CSC

Minutes of 31st Meeting of CSC

Minutes of 32ndMeeting of CSC

Minutes of 33rd Meeting of CSC

Minutes of 34th Meeting of CSC

Minutes of 35th Meeting of CSC

Minutes of 36th Meeting of CSC

Minutes of 37thMeeting of CSC

Minutes of 38th Meeting of CSC

Minutes of 39th Meeting of CSC

Minutes of 40th Meeting of CSC

Minutes of 41st Meeting of CSC

Minutes of 42nd Meeting of CSC

Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products

Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application

These lists are prepared according to types of products and categories of applicant’ firms, as under:-

Cancellation of Enlistment Certificates (Form-6 and Form-7) of two alternative products manufacturers’ for non-compliance to minimum regulatory requirements.

Enlistment Evaluation Committee (EEC) has cancelled the provisional enlistment certificates of two (02) alternative products manufacturing companies for non compliance to minimum manufacturing requirement as per applicable rules. The Committee also cancelled / revoked all the product enlistment certificates issued on the name of these two firms. The cancellation letters have been issued by the Division of Health & OTC to the all concerned authorities.

Decisions of 53rd Meeting of Medical Device Board (Deficiency letters for Imported Medical Devices)

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 53rd meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment