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National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 03) seeking comments from stakeholders

Asad Ullah Drugs, General, Pharmacovigilance

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.

NPVG-guidelines-reviewed-final-9-24-Draft-for-commentsDownload

Orientation Session For Pharmaceutical Manufacturers on PIC/s GMP Guidelines

Asad Ullah Drugs, General

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:

SessionDate
Session 14th September, 2024
Session 26th 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.

PICs-GMP-Webinar-by-DRAPwith-revised-Reg-LinkDownload

DRAP Switched Over to Pakistan Single Window (PSW) for Regulatory Controls on Crossborder Trade at Karachi Custom Stations

Asad Ullah Drugs, General

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.

DRAP-Phase-1-on-PSWDownload

Stakeholders Comments are invited on Draft Guidelines On Submission of Expenditure Details Under the Ethical Marketing To Healthcare Professionals Rules, 2021

Asad Ullah Advertisements, Drugs, General

The Healthcare Industry, comprising various sectors, is interlinked and highly dependent on frequent interactions, coordination, and supportive activities for a sustainable healthcare environment. Among this industry, therapeutic goods establishments and healthcare professionals are two important stakeholders and their interaction is vital and prone to criticism due to its repercussions on patients and the public.

To ensure innovation, progress, and improvement in healthcare and healthcare products while preserving professional ethics and transparency, the Drug Regulatory Authority of Pakistan (DRAP) has taken significant steps in line with the provision of Section 7(q) of the DRAP ACT 2012, which mandated the Authority to monitor and regulate marketing practices to ensure the rational use of drugs and ethical criteria for the promotion of therapeutic goods in line with international practices. In exercising this function, DRAP has notified the “Ethical Marketing to Healthcare Professionals Rules 2021” via S.R.O. 1472(I)/2021 on the 12th of November 2021. These rules outline the major forms of interaction between companies and healthcare professionals.

To facilitate the implementation, DRAP has developed a draft guideline on submitting expenditure details related to marketing activities targeted towards healthcare professionals to provide clarity and ensure compliance with the Ethical Marketing to Healthcare Professionals Rules 2021.

These guidelines are uploaded on the official website of DRAP on the 9th of August, 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 how to submit comments visit the DRAP website or click here. Comments and suggestions can be forwarded via email to aqsa.hashmi∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Chak Shehzad, Islamabad.

DRAFT Guidelines on Data Submission under Ethical Marketing RulesDownload

Bioequivalence and Bioavailability of Drug Products

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.

The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.

Bioavailability-Bioequivalence-StudiesDownload

Report on Availability Status and Supply Disruption of Eye Drops

Asad Ullah Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) has received information that certain brands of eye drops are short in supply in the market. The DRAP’s committee has conducted a quick survey of the market and found certain alternative brands available in the market. The main reason behind their short supply is the change of ownership globally from Allergan to AbbVie.

In this regard, Physicians are advised to consider prescribing the available alternative brands to their patients in light of the shortage. Patients should be informed about this during their consultations. Similarly, pharmacists should also communicate the availability of alternative brands to patients or caregivers.

Briefly, the availability status of eye drops reported short along with their alternative brands is presented in the table below:

Sr. No.Name of Drug ProductsManufacturer/ importerStatusReason / Stock positionAlternate brand available
 1Combigan Eye drops (Brimonidine and Timolol)  M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brytim Eye Drops (Remington)
Imosol eye Drops (Schazoo)
 2Lumigan Eye drops (Bimatoprost)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Allure Eye drops (Sante)
 3Alphagan Eye drops (Brimonidine tartrate)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brimodine Eye drops (Sante)
Brimod eye drops (Remington)
 4Cosopt eye drops (Dorzolamide and Timolol)M/s OBS PakistanShort SupplyStock of 30,000 packs is in transit.Co-Dorzol eye drops (Sante)
Co-Dorz eye drops (Ethical)

Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)

Ijaz Mustafa Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) has recently released the 2nd Edition of the Post Registration Variation Guidelines for pharmaceutical and biological drug products. These guidelines provide essential information for submitting post-registration variation applications by registration holders and marketing authorization holders of drug products. The guidelines distinguish between minor variations (MiV-N, MiV-PA) and major variations (MaV), with specific timelines for each type. Applicants are required to adhere to the prescribed “Form” and documentation requirements when submitting variation applications.

variation-guidelines-Download

Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW).

Drug Import License (DIL)

All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System..

Import of Donations

All registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs are required to submit applications for import clearance on through PSW System from February 29, 2024

PSW-CircularDownload

Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document

Asad Ullah Drugs, General ,

At the Drug Regulatory Authority of Pakistan (DRAP), our commitment to public health and safety drives our actions. We recognize that ensuring the quality and efficacy of pharmaceutical products is paramount. To achieve this, we emphasize risk-based sampling and testing strategies for assuring Safety and Quality of therapeutic goods to safeguard public health.

These Guidelines reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing, and surveillance based on risk levels. This ensures that critical aspects of drug quality receive the attention at first and enable focusing regulatory efforts to high-risk areas. The draft guidelines are prepared based on the recommendation of ICH Q9 (Quality Risk Management), WHO working document QAS/15.630, and USP-PQM guidance document for implementing risk-based post-marketing quality surveillance in low and middle-income countries.

DRAP invites all interested parties and relevant stakeholders to provide their comments and inputs on the draft guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to mehwish.tanveer∂dra.gov.pk with a copy to mahvash.ansari∂dra.gov.pk or can be posted at the following mailing address: Assistant Director (QC-II), Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates your participation and contribution to this consultation process.

GUIDELINES ON RISK-BASED SAMPLING & TESTING OF DRUGSDownload