Pharmaceutical Quality Knowledge Management System (PQKMS) | International Coalition of Medicines Regulatory Authorities (ICMRA)

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