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Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

Asad Ullah Events
Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

Lahore – October 21-22, 2024: The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the World Health Organization (WHO) Pakistan, hosted a provincial workshop on the implementation of Institutional Developmental Plans (IDPs) aimed at strengthening the National Regulatory System of Pakistan based on WHO recommendations.

Mr. Nadeem Mahbub, Federal Secretary of the Ministry of National Health Services, Regulation & Coordination, and Ms. Ellen Mpangananji Thom, Officer Incharge, WHO Office in Pakistan participated in this workshop.

Mr. Asim Rauf, CEO DRAP briefed the participants on the roadmap for strengthening the regulatory system of Pakistan.

This interprovincial coordination workshop was attended by key officials, including the Director General of Provincial Drug Control Administrations, the Chief Inspector of Drugs from all federating units, Directors of National Quality Control Laboratories (CDL and DTLs), officers from provincial regulatory institutions, and teams from DRAP working on the implementation of the Institutional Developmental Plans (IDPs) based on the WHO Global Benchmarking Tool for National Regulatory Authorities.

This 02-day workshop provided the opportunities to strengthen the regulatory framework in all federating units by developing collaborative working procedures in various areas including pharmacovigilance, Market Surveillance, Licensing, Inspection, Laboratory Testing and Quality Management System.

Minutes of 340th meeting of Registration Board held on 1st – 2nd October, 2024

Asad Ullah Meeting Minutes, Registration Board

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.

Minutes of 340th meeting of Registration Board (1)Download

Submission of Replies against Deferred Form-5/5A Applications of Human Drugs

Ijaz Mustafa General

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.

submission-of-replyDownload

Caution Regarding Fake Emails Impersonating DRAP Officials

Yasir Mahmood General ,

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

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.

Ijaz Mustafa General

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.

SWITCH-OVER-TO-PSW-2-1Download