medicines-medical devices-regulatory affairs
Last updated: 13 December 2025 To view updates, click on the ‘+’ sign below. Checklist for the submission of day 215 translations for post-opinion linguistic review – human You can view the document with the above title, here. For initial…
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.…
Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…
Last updated: 11 December 2025 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…
Last updated: 11 December 2025 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…
Date Title of guidance and link to document Type and levelof guidance About the guidance 9 Dec 2025 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers final, Level 1…
Last updated: 9 December 2025 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the…
Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. The commission delegated regulation (EU) 2024/1701 Timeline of…
Last updated: 1 December 2025 To view updates, click on the ‘+’ sign below. Highlights from the Clinical Trials Coordination Group (CTCG) plenary meeting On 3–4 November 2025, CTCG met at EMA to discuss initiatives aimed at streamlining clinical trial…
On 27 November 2025, a large number of National Competent Authorities (NCAs) and Ethics Committees committed to test a coordinated fast-track approach for evaluating multinational clinical trials. About the FAST-EU (Facilitating and Accelerating Strategic Trials) initiative When is the FAST-EU…
The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536 These updates, published on…