Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines

Close collaboration between medicines regulators worldwide is paving the way towards the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS). The goal is to ensure patients can benefit from a continuous supply of life-saving medicines in a world where changing manufacturing processes, technological innovations and complex supply chains can, among other factors, affect the availability of medicines.

On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by the International Coalition of Medicines Regulatory Authorities (ICMRA) and industry representatives under the International Federation of Pharmaceutical Manufacturers and Traders (IFPMA). During the workshop, participants explored collaborative approaches to support alignment of regulatory requirements to ensure the quality of pharmaceutical products. A summary report of the workshop has been published, outlining progress made as part of ICMRA’s PQ KMS project and initial key learnings from its two pilot programmes, with perspectives from regulators and industry representatives.

The pilots focus on two essential parts of medicines evaluation: collaborative assessments of post-approval changes and hybrid inspections. Building on lessons from the COVID-19 pandemic, the goal is to significantly reduce the need for multiple submissions from companies, avoid duplicative assessments by regulators, and facilitate inspection reliance to build stronger global resilience.

More information on the EMA Website.