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.
Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [PDF]
Statement in other languages
- Arabic - بيان التحالف الدولي حول إدارة معرفة الجودة الصيدلانية العالمية لتعزيز الاعتماد التنظيمي ومرونة التنفيذ
- French - Gestion globale des connaissances sur la qualité des produits pharmaceutiques : Améliorer la fiabilité et l’agilité de la réglementation [PDF]
- Japanese - グローバルな医薬品品質知識管理: レギュラトリー・リライアンスとアジリティの向上 [PDF]
A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines
The International Coalition of Medicines Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), International Pharmaceutical Regulators Programme (IPRP) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are working to harmonise pharmaceutical quality knowledge management to improve the availability of high-quality medicines. Their shared vision for the development of a global pharmaceutical quality knowledge management system (PQ KMS) is outlined in a joint reflection paper [PDF].
PQ KMS Pilot Updates
In the interests of transparency and to ensure key stakeholders are informed, the current page will provide regular updates on the current status of each collaborative pilot. Further information will also be provided on the rationale for choosing specific applications to participate in each pilot.
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