The Drug Registration Board convened 340th meeting on October 1 – 2, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Month: October 2024
List of Clinical Trials Approved Under Bio Study Rules
Submission of Replies against Deferred Form-5/5A Applications of Human Drugs
In its 339th Meeting, convened from August 6-8, 2024, the Registration Board has issued a directive that all applicants should submit clarifications or replies for their deferred Form-5/5A applications by December 31, 2024. It is imperative to note that any submissions received after this deadline will not be considered, and will be be classified as disposed of, necessitating the submission of a new application on Form 5F.
This initiative is designed to enhance the efficiency of the registration process and ensure strict adherence to current regulatory standards. This directive is in accordance with the implementation of the Form 5F (CTD) format for drug registration, effective March 31, 2019, which requires that all applications be evaluated based on the updated Form 5F data guidelines.
Consideration of Form-5/5D Applications for Registration of Drug Products: Stability Data Submitted Before 30th June, 2023
List of applications submitted by the firms for provisional enlistment of H & OTC products received from 01st January 2023 to 31st December 2023 (Nutraceutical, Herbal, Homeo)
Caution Regarding Fake Emails Impersonating DRAP Officials
It has come to our attention that some individuals are receiving fraudulent emails impersonating officials of the Drug Regulatory Authority of Pakistan (DRAP). Please be advised that all official DRAP correspondence comes from email addresses ending with @dra.gov.pk.
Stakeholders and the public are urged to remain vigilant and verify the authenticity of any communication. If in doubt, kindly contact DRAP through official channels.
Thank you for your attention to this matter.
Drug Regulatory Authority of Pakistan
Tender document / terms & conditions for hiring of security companies for provision of security services at DRAP offices
Notice on Tender opening for provision of high speed internet
Tender opening for provision of high speed internet which was due on Monday, 14th of October 2024 is postponed in lieu of local holiday by Federal Govt in Islamabad. The same will now be opened on Thursday, 17th of October 2024 at 02:00 pm in committee room of DRAP. The closing date for submission of bids will however remain same i.e. Monday 14th of October 2024.
Invitation to bid (for stationery & other miscellaneous items)
Switch over from Web Based One Customs (WEBOC) to Pakistan Single Window (PSW) for submission and issuance of all types Drug Import Licenses (DILs) and issuance of electronic release orders through PSW’s Single Declaration (SD) system.
We are pleased to announce that, effective October 8, 2024, the clearance of commercial imports (HC type) of all commodities (Drugs) requiring a Drug Import License (DIL) mandated by the Drug Regulatory Authority of Pakistan (DRAP) being imported at customs stations of Peshawar and Islamabad are being switched from WeBOC to PSW system. All the DRAP-related commodities (Drugs) will be completely shifted over to PSW, and clearance will be subject to the electronic issuance of a Release Order by DRAP through the filing of a Single Declaration (SD) on all customs stations located in Peshawar and Islamabad.
All traders/importers engaged in the import of these commodities falling under the purview of DRAP are informed to file Single Declaration (Imports) through PSW System for issuance of electronic Release Order from DRAP and Customs clearance of their import consignments w.e.f. 08th October 2024.