medicines-medical devices-regulatory affairs
Last updated: 05 February 2026 To view updates, click on the ‘+’ sign below. Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert…
On 19 January 2026, The Prescription Medicines Code of Practice Authority (PMCPA) guidance on package deals was published. There are many different types of package deals and therefore it is difficult for the PMCPAto give universal guidance in this area.…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
About the reliance pilot programme EMA and WHO are supporting a pilot programme that enables pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities. Why is the reliance pilot programme deemed necessary? Regulatory authorities use reliance extensively when…
Last updated: 3 February 2026 To view updates, click on the ‘+’ sign below. The worksharing procedure for the assessment of Active Substance Master File (ASMF) The document with the above title has been updated. Here, you can view the…
Last updated: 30 January 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. In summary: The commission delegated regulation (EU) 2024/1701 Timeline…
Last updated: 30 January 2026 See updates below. This post is an attempt to provide basic information about the Access Consortium, a collaborative initiative of regulatory agencies. Click on the ‘+’ sign next to each heading to access the information…
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Jan 2026 Clinical Decision Support Software Final The purpose of this guidance is to describe FDA’s regulatory approach to CDS software functions. The Agency’s…
Last updated: 21 January 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales…
This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) is a pilot initiative by the Heads of Medicines Agencies (HMA),…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
What is the OPEN framework? The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities). Brief history of the OPEN framework Date Event Dec…