Pakistan: In-Depth Guidance by DRAP on Application of Drug Product Specifications

ARQon
Dec 27, 2023
2 min read

The Drug Regulatory Authority of Pakistan (DRAP) decided to release the guidance of the finished drug product specifications to the pharmaceutical industry to ensure the standards are on par with the DRAP Act 2012 and The Drug (Specification) Rules 1978.

1. Drug Product Has Been Published in Pharmacopoeias Accordingly To Drug Specification Rules (1978)

The firm is allowed to adopt the specifications from any pharmacopoeias as per the procedure mentioned within 1 year and shall apply for approval from the Registration Board DRAP. Till the approval from the Registration Board;

The previous specifications approval by the Registration Board remains valid
Specifications stated in S.No.2, Column 1 of rule No.2 of the Drugs (Specifications) Rules (1986) will be applied for any registration letter with no specifications mentioned but the drug products available in any pharmacopoeias
Specifications of the innovator/manufacturer products that have been approved by any regulatory authority of reference countries will be accepted if neither the specification mentioned in the label nor the pharmacopoeias

2. Pharmacopoeia specifications of the relevant products that are subject to approval by the Registration Board, which are approved by the pharmacopoeia of the regulatory authorities from the reference countries that are approved by the Registration Board including FDA (USA), Health Canada (Canada), TGA (Australia), PMDA (Japan), UK MHRA (United Kingdom), BfArM (Germany), ANSM (France), Swissmedic (Switzerland), MED (Netherland), BASG (Austria), DKMA (Denmark), Läkemedelsverket (Sweden), FAMHP (Belgium), Icelandic Medicines Agency (Iceland), Fimea (Finland), HPRA (Ireland), NoMA (Norway), AEMPS (Spain), AIFA (Italy), and reference regulatory authorities of the EMA and WHO

3. For cases of drug products that are not yet available in pharmacopoeias as specified under Drug Specification Rules (1978)

The firm may apply the innovator/manufacturer product specifications as approved by the regulatory authority of the reference countries but will remain valid only till the inclusion of the products in any of the pharmacopoeias as specified under Drug Specification Rules (1978). The firm shall apply the approval from the Registration Board of DRAP within 1 year period
Generic applicants that prefer to manufacture with their specifications, must submit the data stated below for review and approval by the Registration Board of DRAP:

Source: Drug Regulatory Authority of Pakistan (DRAP)