Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements and maintain a balance between the potential health benefits and risks posed by the therapeutic products.

Main objective of this document is to: 

• Provide an updated and revised proposed licensing system for DRAP based on the progressive licensing system. 
• Improve the inspection system in-line with international standards to achieve the PIC/S membership within a reasonable time period.

Progressive Licensing System:

Progressive Licensing System is developed as an approach for the modernization of the framework for the regulation of the therapeutic goods. This establishing system will be applicable to the premises where therapeutic goods are manufactured, processed, packaged/labeled, tested, imported, distributed and stored.

DRAP is committed to ensure that therapeutic products are safe for the patients and consumers by managing the health-related risk and benefit of products by:

This proposed progressive licensing system will issue licenses to establishments supported by using new prohibitions and conditions and licenses holder is required to meet all the elements of cGMP and maintain QMS in accordance with ICH guidelines and responsible for fulfilling all the conditions required by using the regulations.

Foreign inspection will be conducted based on the risk, country and its regulatory authority status and it is exempted for SRAs Countries, PIC/S member countries, WHO Pre-qualified facilities and or well-established forum such as EEA – EFTA.

In the new progressive licensing system new licenses will be granted for the period of three years. The frequency of inspection will be primarily based on the licensed activities, level of risk and priorities.