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Stakeholders Comments are invited on revision of Guidelines on Conduct of Clinical Trials in Pakistan

Asad Ullah Clinical Trials, Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.

The revised guidelines cover various aspects of clinical trial activities, such as:

  • The regulatory framework and approval process for clinical trials in Pakistan
  • The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
  • The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
  • The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
  • The good clinical practice (GCP) requirements for clinical trial materials and investigational products
  • The data management and quality assurance systems for clinical trial data and documents
  • The post-trial obligations and follow-up measures for clinical trial sponsors and investigators

The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.

The revised guidelines are open for public comments until February 22, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

Draft-Guidelines-for-Conduct-of-Clinical-Research-in-Pakistan_06_02_24_AmendedDownload

Registration Board Direction; Procedure for Capacity Assessment of the Contract Acceptor

Asad Ullah Drugs, Regulatory Updates

Registration Board in its 333rd meeting held on 19th – 20th December, 2023 discussed the subject mentioned case and decided as under: –

1.         Inspection of contract accepter for manufacturing / testing capacity assessment shall be conducted for all those contract manufacturers, who has not been inspected for such purpose with in the last 3 years. The panel shall verify capacity assessment of all those sections, which are approved by the Licensing Division.

2.         Capacity assessment of newly applied facility (Section) shall not be carried out, if any section of that manufacturing facility has already been assessed within last three years.

3.         Following shall be prerequisites for submission of application for contract manufacturing under Rule 20(A) of Contract Manufacturing Policy.

a.         Affidavit on stamp paper (Showing name, designation, CNIC Number of contract giver) stating installed capacity of the contract accepter for contract manufacturing. This affidavit shall only be signed by the CEO / MD of the firm. i.e. contract accepter.

b.         Copy of DML of both firms. i.e. contract giver and contract accepter along with Section (s) approval from Licensing Division.

c.         Valid GMP certificate or GMP inspection report of the contract accepter, conducted within last three years.

d.         Copy of legalized contract between contract giver and contract accepter on stamp paper presenting the capacities of the contract accepter for the manufacturing sections for whom the products have been applied, and

4.         Affidavits submitted by the contract accepter, showing manufacturing / testing capacity, will be verified in the subsequent inspections conducted for GMP / renewal of DML and will be reported accordingly. Chairman, Registration Board may constitute panel of experts to verify capacity assessment, if required.

5.         The capacity verification report will be valid for 3 years.

RB Direction Mar 24Download

DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods

Asad Ullah Drugs, General, Licensing and Inspections

The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.

The draft guideline covers the following aspects:

  • The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
  • The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
  • The methods for destroying in an environmentally sound manner.
  • The records and reports that need to be maintained and submitted.

The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at sanaullah.babar∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.

Guidelines-for-storage-and-destruction-of-recalled-therapeutic-goods-_-V1Download

DRAP Added New eService for Online Data Submission for Registration of Pharmaceutical and Biological Product

Asad Ullah Drugs, News & Updates, Regulatory Updates

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the addition of a new e-service for online regulatory data submission registration/marketing authorization of human drugs for local manufacturing, import and export. The Licensing Operations of all [pharmaceutical and biological manufacturers are already enabled through the same plateform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan which aim to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

The e-service requires applicants to submit their data in a standardized format, as specified in the following documents:

  • Data Submission Format for Licensing Operation of Pharmaceutical Manufacturers
  • Data Submission Format for Registration of Human Drugs
  • Data Submission Format for Renewal of Registration of Human Drugs
  • Data Submission Format for Variation in Registration of Human Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which is accessible after registering an account with DRAP. The e-service offers several benefits, such as:

-Faster and easier data submission and processing.
-Reduced paper work and redundancy

-Increased transparency and visibility

This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService and will beWe welcome your feedback and suggestions on how to improve our services. Please contact us at info∂dra.gov.pk or +92 51 9260 500 for any queries or assistance. Thank you for your cooperation and support.

You can access the new e-service by clicking on this link:

eApps-CircularDownload

National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products

Asad Ullah Drugs

The regulation of lot release is an integral regulatory control to ensure the quality and safety of biological products. Its purpose is to verify that each batch/lot of the product meets the stipulated standards of manufacturing and quality control. The National Control Laboratory for Biologicals (NCLB), Islamabad assumes the responsibility of overseeing lot release function through reviewing the manufacturer’s protocol, analytical methods and summary protocol, and also conduct analytical testing if necessary. This is aimed at assuring that every product batch/lot that enters the market adheres to the approved specifications at the time of registration, including any post-registration modifications or variations. The primary objective is to safeguard the public from substandard product batches/lot.

The National Control Laboratories for Biologicals, DRAP has published guideline on the procedural requirement for lot release of biological products. This guidance document was drafted and uploaded in May 2023 seeking comments from stakeholders. It provides an overview of the lot release process how the procedure is established and what products are covered under the lot release system.

Guideline for lot release of biological drugsDownload

DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

Asad Ullah Drugs

DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle.

This guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.

The Guidelines have been finalized keeping in view the comments and suggestions of the Stakeholders. Please navigate to the Publications on the DRAP website for latest guidelines by DRAP.

Post Registration Variation Guidelines (Edition 02)Download

The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.

Ijaz Mustafa Drugs, General, Notifications, Pharmacovigilance , , , , , ,

Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.

Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.

The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.

According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:

  • To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
  • To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
  • To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
  • To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
  • To maintain pharmacovigilance records and documentation for at least 10 years.

“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”

FrontScans003Download

Training on Pakistan Single Window for DRAP Module

Asad Ullah Drugs, Events, Licensing and Inspections, Regulatory Updates , , ,

Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._

In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.

The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.

Interested members are requested to register themselves by clicking below:
Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g

Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.

Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021.

Asad Ullah Drugs, General, Notifications

The Ethical Marketing to Healthcare Professionals Rules have been notified vide SRO 1472(I)/2021 on the 12th of November 2021 by the Drug Regulatory Authority of Pakistan. These rules have been promulgated to make the interaction between companies and healthcare professionals transparent, free from corrupt practices and to facilitate medical decisions making in the best interest of the patient.

The aforementioned rules require therapeutic goods companies to submit marketing expenditure details under rule 14(2) and annual compliance certificate under rule 13(h). Subsequent to the notification of these rules, DRAP has drafted an implementation strategy which requires systematic data submission.

The implementation strategy is aimed at harmonized data submissions by stakeholders in a systemic manner, we have drafted followings formats for data submission:-

Comments from therapeutic goods companies, healthcare professionals and relevant stakeholders are invited on the draft documents within 15 days. These comments along with justification are to be submitted using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to drap.pharmacy∂gmail.com, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Islamabad.