Regulatory Updates
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
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.
Invitation to Bid (Provision of high speed redundant internet connectivity services at DRAP Headquarters, Islamabad)
National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 03) seeking comments from stakeholders
The Drug Regulatory Authority of Pakistan (DRAP) has set up the National Pharmacovigilance Centre (NPC) in Islamabad to oversee the safety of medicinal products nationwide. The NPC collaborates with national and international entities to establish an effective pharmacovigilance system in Pakistan. Since 2018, Pakistan has been a full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM) based at the Uppsala Monitoring Centre (UMC) in Sweden.
The NPC has developed a multi-channel reporting system, including electronic and manual reporting forms available through website and mobile applications for healthcare professionals and the public. The Pharmacovigilance Rules, 2022, apply a legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.
The 1st edition of these guidelines was drafted as per the draft Pharmacovigilance Rules and had chapters and sections for the guidance of healthcare professionals, patients and registration holders. Subsequently, the National Pharmacovigilance Centre (NPC) issued separate guidelines for the above pharmacovigilance stakeholders and also Pharmacovigilance Rules, 2022 were officially notified vide S.R.O 540 (I)/2022 dated 22nd April 2022. Therefore, the NPC-issued 2nd edition of guidelines with the title “Guidelines on the National Pharmacovigilance System” which were prepared in line with Pharmacovigilance Rules, 2022. All those sections /chapters for the guidance of the above stakeholders were removed and the WHO PV indicators were incorporated in Chapter 11 in the 2nd edition of the guideline. This 3rd edition of these guidelines has been drafted in light of WHO recommendations in the form of Institutional Development Plans (IDP) made during its assessment of the National Regulatory System of the DRAP. As per WHO recommendation and DRAP’s Authority decision, the PRAEC has now been given an advisory role in relation to signal management and risk assessment; whereas, the NPC has been mandated to perform signal management and risk assessment process and to make decisions in the context of risk minimization and recommendation of regulatory actions to concerned Boards and Committees of the DRAP.
These guidelines are uploaded on the official website of DRAP on the 16th of September, 2024 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to pv∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Orientation Session For Pharmaceutical Manufacturers on PIC/s GMP Guidelines
The Drug Regulatory Authority of Pakistan (DRAP) is dedicated to enhancing the regulatory framework to meet international standards and elevate the pharmaceutical sector in Pakistan. As part of these efforts, DRAP is aspiring membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for inspectorates in the field of Good Manufacturing Practice (GMP) of drug products.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S is a mutual cooperative arrangement between regulatory authorities in the field of GMP for medicinal products. PIC/S aims to harmonize inspection procedures globally by developing common standards in GMP and facilitating cooperation and networking between competent authorities, regional, and international organizations, thereby increasing mutual confidence.
Virtual Orientation Sessions
To raise awareness in the industry about the PIC/S theme and GMP guidelines, and to facilitate a phased transition towards adopting these guidelines, DRAP will conduct a series of virtual orientation sessions for pharmaceutical manufacturers. The tentative schedule for the first two sessions is as follows, with further sessions to be announced later:
| Session | Date |
| Session 1 | 4th September, 2024 |
| Session 2 | 6th September, 2024 |
Interested participants are required to complete the registration form by 31st August, 2024. The virtual session links will be emailed to registered participants with the session agenda.
DRAP Switched Over to Pakistan Single Window (PSW) for Regulatory Controls on Crossborder Trade at Karachi Custom Stations
The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce that, effective August 15, 2024, we have successfully transitioned from the Online Import Export System (OIES) to the Pakistan Single Window (PSW) for processing applications related to the clearance of commercial imports of raw materials and finished drug products at Karachi Seaport and Airport customs stations.
Pakistan Single Window (PSW) is an electronic portal enabling cross-border trade using standardized information and documents through a single entry point for all import, export, and transit-related regulatory requirements. The information is transmitted electronically, and individual data elements for clearance and regulatory approvals need only be submitted once. Authorized users who have completed the subscription process can access the PSW to perform cross-border procedures, including online payment/fees.
Key Highlights of the Transition:
- Single Declaration Release: DRAP officers are now electronically issuing Release Orders through a Single Declaration (SD) system, streamlining the import/export process for pharmaceutical products.
- Trade Automation: The new system allows for 24/7 electronic submission of cross-border trade applications, including online payment of fees and controlled data processing by authorized users.
- Single Entry Point: Users can now submit standardized information and documents just once, simplifying the application process.
- Clear Visibility and Application Tracking: The PSW system provides clear visibility of actions on applications, eliminating the need for physical visits for application follow-ups. It also allows for electronic calls on documents for any shortcomings.
DRAP Operations at PSW Include:
- Entity Registration: Onboarding of existing Drug Manufacturing Licenses (DMLs), product registrations, and importers with existing drug sale licenses.
- Raw Materials & Finished Drugs: Processing of drug import licenses (Form 5), clearance certificates for the import of raw materials, finished drugs, and controlled drugs.
- Clinical Trials, Tests & Analysis: Issuance of drug import licenses for test analysis (Form 6) and clearance certificates for the import of drugs/medicines for clinical trials.
- Hospital/Institutional Use & Donations: Import permits for unregistered/unavailable drugs and clearance certificates for donation medicines.
Additional Information:
- DRAP Notification: DRAP has issued a notification regarding this transition to ensure all stakeholders are informed and prepared for the new process.
- PSW User Manual: PSW has issued a comprehensive user manual to guide users through the new system, ensuring a smooth and efficient transition.
For further assistance, please contact us at 021-111-111-779 or email support∂psw.gov.pk.