Month: April 2022
DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country
DRAP has a regulatory oversight on import and export of all type of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws, and refuses the entry or exit of any therapeutic good in case of noncompliance to the regulatory requirements.
“Import and export of any therapeutic goods prohibited under Rule 23 of the Drugs Act 1976 and Schedule II of the DRAP Act 2012 are punishable under Rule 27 of the Drugs Act 1976 and Schedule III of the DRAP Act, 2012”
These regulatory controls are applied to prevent the infiltration of substandard and suspected falsified medicine into the supply system and to assure the access to standard quality therapeutic goods. This guidance document will elaborate the requirements, procedures for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. It covers the both import and export of therapeutic goods for commercial and non-commercial purposes, and also provides guidance on determination of the eligibility of importers and exporters.
Please click to access the final guidance document on “Import and Export of Therapeutic Goods“
The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.
For more information on regulatory guidelines issued by DRAP, please navigate to our section on “Regulatory Guidelines“
Mr. Asim Rauf, CEO, DRAP met with WHO Country Representative, Dr Palitha Gunarathna Mahipala to promote bilateral cooperation
Mr. Asim Rauf, CEO DRAP met with WHO Country Representative for Pakistan, Dr Palitha Gunarathna Mahipala on Monday 25th April, 2022 at WHO Country Office, Islamabad, to discuss the bilateral cooperation among WHO and Drug Regulatory Authority of Pakistan.
Dr. Mahipala appreciated the efforts of DRAP and Ministry of National Health Services, Regulation & Coordination for strengthening the national regulatory framework to ensure and enhance the access of quality assured, safe and efficacious therapeutic goods in the country for better health of the people of Pakistan. Mr. Asim Rauf, acknowledged the role of WHO and country office’ team for extending assistance in various health programs which are improving the access of Pakistani citizen to quality assured therapeutic goods.
The meeting ended with the reiteration of the commitment from WHO and DRAP for strengthening the bilateral cooperation and to take all possible measure for protecting the health of the people of Pakistan.
DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country
The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).
The Pharmacovigilance Rules,2022 are aimed at :-
- Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
- Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
- Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
- Better communication and collaborative working among all stakeholders.
To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”
National Pharmacovigilance Centre, DRAP issued draft guidelines on promoting Pharmacovigilance activities in Public Health Programs (PHPs).
Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.
The key objectives of pharmacovigilance activities in public health programs are:-
- To improve public health and safety in relation to the use of therapeutic goods in PHPs;
- To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
- To encourage the safe, rational and more effective use of therapeutic goods.
This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.
Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂dra.gov.pk, or can post at mailing address, Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Please click here to view draft guidance document GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES
Drug Product Recall: Water for Injection (Batch # 826) by M/s. Zafa Pharmaceutical Laboratories Pvt Ltd, Karachi.
DRAP issues a guidance for Healthcare Professionals on reporting of Adverse Events to the Pharmacovigilance Centers
DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the therapeutic goods’ safety across the country. NPC has developed different reporting channels that are available through the official website of DRAP and a mobile application (MED Safety) for reporting of any Adverse Events (AE) to ensure the safety of therapeutic goods.
These guidelines details the principle requirements for Adverse Events reporting by Healthcare Professionals and provide guidance on reporting channels available to the Healthcare professionals for AE reporting. HCPs are responsible for the timely identification, documentation, and reporting of AEs and their contribution is essential to the early detection and reporting of an AE. The purpose of this document is to. –
- Guide and enlighten HCPs about reporting AEs to NPC, DRAP;
- To enhance the participation of HCPs in the reporting system of the country; and
- To develop a spontaneous reporting culture in the country to ensure therapeutic good’s safety.
Click to view the guidance document of ADVERSE EVENTS REPORTING GUIDELINES FOR HEALTHCARE PROFESSIONALS
DRAP asks stakeholders to comment on the draft guidelines on Bio-availability & Bio-equivalence studies for generic drug products
The Drug Regulatory Authority of Pakistan (DRAP) ensures that all pharmaceutical drug products conform to acceptable standards of safety, efficacy and quality. This guidance will be applicable to orally administered generic drug products as well as to non-orally administered pharmaceutical products for which systemic exposure measures are suitable for documenting bioequivalence.
This document will provides guidance to the industry for in vivo and in vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product.
Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Please click to view the “Draft Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products”
Stakeholders comments are invited on draft Guidelines for Labeling & Packaging of finished drug products.
This guidelines are aimed to assist industry (marketing authorization holders) in drawing up the label and package leaflet for their products in compliance with the Drugs (Labelling and Packing) Rules 1986. This documents will provide specific requirements for the labelling and packaging of pharmaceutical and biological drug products.
The purpose of the guidelines are:-
- To provide guidance on how to ensure that the information on the label and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine or ensure its use safely and appropriately.
- To help achieve consistency, transparency, clarity, efficiency and high quality in both the content and management of reviews.
- This guideline is written to assist applicants and marketing authorization holders when drawing up the label and package leaflet
Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Please click here to view draft guidance document Draft Guidelines on Labelling and Packaging of Drug Products
DRAP seeks comments of stakeholders on draft guidance document for Clinical Trials Applicants
The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP). The current guideline describes the regulatory requirements, procedure for submission, review, evaluation and approval of applications for the conduct of clinical trial.
These guidelines are applicable on the sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.
These guidelines will assist researchers / investigators on the procedures for filing applications of clinical trials and will provide an insight on the steps to be followed by the applicants who wish to conduct clinical trials in Pakistan. It is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan (DRAP) and any clinical trial using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.
Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to dir.ps∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Please click here to view draft guidance document Guidelines for Clinical Trials Applications