medicines-medical devices-regulatory affairs
Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. Updated PLM Portal eAF Release notes now available An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the…
Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
Last updated: 10 June 2025 To view updates, click on the ‘+’ sign below. What is Decentralised Manufacturing? Point of Care (POC) and Modular Manufacture (MM) are collectively described as Decentralised Manufacture (DM). Which product types are included as POC…
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: 9 June 2025 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: 12 June 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: 12 June 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 5 Jun 2025 M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) Draft This template is intended for interventional clinical trial protocols and is suitable for…
Last updated: 29 May 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: 29 May 2025 To view updates, click on the ‘+’ sign below. Report from the CMDh meeting held on 20-21 May 2025 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting…