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Pharmaceutical Quality Knowledge Management System (PQKMS)

 

The International Coalition of Medicines Regulatory Authorities (ICMRA) has developed a joint statement on the establishment of a pharmaceutical quality knowledge management system, which could help to better inform both public and industry stakeholders on the coalition’s efforts to improve global regulatory harmonisation and alignment.
 
Regulatory authorities can gain efficiencies by developing common procedures, guidelines, requirements, and interoperable infrastructure that would facilitate the timely sharing of information on changes occurring within the supply chain of medicines. This may include reliance on the assessments of other regulators but could lead to more timely availability of medicines for patients by shortening approval timelines.

Following an initial period of consultation with the broader ICMRA membership, the ICMRA Executive Committee formally established a PQ KMS Working-Group with specific responsibility for advancing efforts needed to develop a PQ KMS capability.

PQKMS Statement

Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [PDF]

Statement in other languages

 

PQKMS Collaborative Pilot Information and Application Forms

Following the July 2021 ICMRA-Industry virtual workshop on enabling manufacturing capacity in the COVID-19 pandemic, ICMRA is commencing two pilot programs focusing on i) collaborative assessment with initial focus on chemistry, manufacturing, and  control (CMC) post-approval changes and ii) collaborative hybrid inspections. The overall aim of these pilots is to improve manufacturing capacity for production of critical medicines and facilitate collaborative assessments and inspections by multiple regulatory authorities (see links for further information).

Call for Applications to PQ Pilots

Application Form for Collaborative Assessment

Application Form for Collaborative Hybrid Inspection

Overview of Collaborative Assessment

Overall Plan for Collaborative Assessment

Overview of Hybrid Inspection

Overall Plan for Hybrid Inspection