medicines-medical devices-regulatory affairs
Last updated: 13 February 2026 This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. For updates, click on the ‘+’ sign below. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…
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.…
Last updated 12 February 2026 To view updates, click on the ‘+’ sign below. Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form This guidance (Rev 1.0 12 February 2026) aims at supporting…
Last updated: 6 February 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. Legal Framework What are some of the changes introduced…
Date Title of guidance and link to document Type and levelof guidance About the guidance 6 Feb 2026 E22 General Considerations for Patient Preference Studies Draft, Level 1 This harmonised ICH guideline outlines general considerations about the use, design, conduct,…
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.…
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 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…
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…
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…