December 2021 – Drug Regulatory Authority of Pakistan

Draft Guidelines On Good Pharmacovigilance Practices For Registration Holders for view Comments to be Submitted to National PV Center DRAP till 15th January, 2022

Murtaza Awan General December 29, 2021January 6, 2022Pharmacy Services

Guidelines On Good Pharmacovigilance Practices For Registration Holders

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User Guide For Online Import / Export Applications Software

Murtaza Awan Drugs, General December 28, 2021January 6, 2022QA & LT

User Guide For Online Import / Export Applications Software.

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Drug Product Recall: Dextrose 25% Infusion (Batch# A042C21) by M/s Otsuka Pakistan Ltd, Hub, Baluchistan

Murtaza Awan Recall Alerts December 28, 2021February 22, 2022QA & LT

CDL has declared Dextrose Infusion 25% (Batch # A042C21) as substandard, Manufactured By M/S. Otsuka Pakistan Ltd., Hub.

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Pre-Submission Screening Checklist for Biological Registration Dossier

Murtaza Awan Drugs December 22, 2021December 27, 2021Guidelines

Application shall be received for detailed evaluation if all the below mentioned documents are submitted.

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Holding Of E-Kachehri

Murtaza Awan News & Updates December 18, 2021December 29, 2021Other

As per directions of Prime Minister’s office for reaching out to public through Khuli E-Kacheri, CEO-DRAP has been pleased to schedule holding of 13^th Khuli E-Kachehri through LIVE session on official Facebook page of DRAP (www.facebook.com/officialDRAP) on 22^nd October-2021 (Friday) at 10:00 am to address public complaints relating to DRAP.

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Certificate Of Good Manufacturing Practices (GMP) For Establishment Units Manufacturing Medical Devices: Policy Board Decision.

Murtaza Awan Medical Devices December 17, 2021December 27, 2021Other

“The Board in order to ensure conformance to standards decided that validity of GMP certificate for local manufacturing will be one year for first three years for grant of Establishment License and thereafter validity will be for three years.

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Training: Implementation of online software for import export clearance

Yasir Mahmood General December 16, 2021December 27, 2021Other

Training announcement for software for import export clearance (therapeutic goods raw material).

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Minutes of 283rd Meeting of Central Licensing Board held on 28th October 2021

Asad Ullah Central Licensing Board December 13, 2021March 18, 2024

283rd meeting of CLB held on 28th October, 2021 Download

Deficiency letter of all deferred products in 93rd meeting of EEC held on 11-08-2021

Yasir Mahmood Alternative Medicines December 13, 2021December 29, 2021Other

applicants were placed before the Enlistment Evaluation Committee (EEC) in its 93rd meeting held on 11th August, 2021 and the same have been deferred being deficient of the information / documents.

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Drug Product Recall: Practel Paediatric Oral Suspension (Batch# AA008) by M/s Health Care Pharmaceuticals, Multan

Murtaza Awan Recall Alerts December 8, 2021February 23, 2022QA & LT

Practel Paediatric Oral Suspension-Manufactured By M/S. Health Care Pharmaceuticals, Multan.

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