Best practices as recommended by WHO and United States Pharmacopoeia are being implemented for performing tests on therapeutic goods.
Recent Updates
- Draft Guidance Document For Clinical Trials Of Biological Products (Manufacture Locally) November 5, 2024
- Notification for GCP Inspections November 1, 2024
- Decisions of 72nd Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications November 1, 2024
- Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders October 30, 2024
- Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL) October 29, 2024
- Career Opportunities: Applications are invited for Various Positions in DRAP October 29, 2024
- Advisory: Medication Safety and Supply Chain Integrity for Procurement of Therapeutic Goods October 28, 2024
- Recall Alert: Drug Product; Famila 150mg Injection (Batch # 083) By Zafa Pharmaceutical Laboratories, Karachi October 25, 2024
- Rapid Alert: Contaminated Propylene Glycol (Batch# YF01230522) October 25, 2024
- Rapid Alert: Unregistered and Falsified RBST Injection Confiscated October 25, 2024
Leadership
Announcement
We are pleased to announce that the Drug Regulatory Authority of Pakistan (DRAP) has shifted its head office from G-9/4, Islamabad to the new location in Prime Minster's National Health Complex, Islamabad. All new correspondence should be addressed to our new head office location. Please update your records accordingly. Additionally, we are currently in the process of transferring and we are committed to ensure smooth transition to avoid any inconvenience during this time. Thank you for understanding and cooperation.
E-Services
With the effective use of Information Technology, we have implemented a number of online services and continually working for more. Click Here to Register an account for following online services. Online Challan & Fee Submission fee.dra.gov.pk Commercial Import & Export
Guidelines
Regulatory compliance is essential and indispensable in order to assure the safety, quality and efficacy of therapeutic goods. Guidance documents published by the Authority are meant to explain the current interpretation or policy for better understanding of the industry and
Quality Control Labs
For ensuring quality therapeutic goods, a network of quality control laboratories has been established. DRAP approved products and suspect therapeutic goods are tested for their quality in accordance with best international practices. To keep the citizens safe from substandard and
Therapeutic Products Recalls
The Recalled Product Index provides access to consumers, healthcare professionals, industry, hospitals and sale outlets related to the information of recalled action taken for defective therapeutic goods. The following section provides an index of recalled actions in which a public
Health Professional Alerts
DRAP’s issues safety updates and alerts related to the therapeutic goods in order to ensure that healthcare professionals and other stakeholders have timely access to the relevant information on safety, quality and efficacy issues or benefit/risk evaluations of the drugs,
Open Consultations
Public consultation enables organizations to consider views and ideas from the citizens and relevant stakeholders during the development of new regulatory mechanisms, either through the enactment of new rules and policies or changes to existing ones or by the development
eApp and centralized Case Management System
We are delighted to announce that DRAP has enabled eApp for Drug Licensing & Registration application submissions. Moreover, we have introduced centralized Case Management System in the same portal for enhanced efficiency and transparency.
Do you know?
DRAP ensures that every drug, medical device or cosmetic, alternative medicine and health product must have a certain standard of quality and is safe and effective for your use. See in links below how it is done and what to do in case you find a suspect therapeutic good.