medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 12 Jun 2026 Forms FDA 3542a and FDA 3542: Questions and Answers Draft This guidance is intended to assist new drug application (NDA) applicantsand NDA…
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: 11 June 2026 To view updates, click on the + sign below: TEAM NB Position Paper on IVDR Application and appropriate surveillance Transfer agreement Team-NB members adopted a template Agreement form related to the transfer of IVDR formal…
Last updated: 9 June 2026 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: 8 June 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Last updated: 28 May 2026 To view updates, click on the ‘+’ sign. Q&A on Periodic Safety Update Report (PSUR) Single-Assessment (PSUSA): Guidance document for assessors Revision 1 (17 Apr 2026) of the documents with the above title has been…
This post is an attempt to provide salient information on Case C-456/24 which concerns Halozyme Inc. vs the Supreme Administrative Court, Czech Republic. Specifically, it concerns the events leading up to the CJEU getting involved in the case as well…
Last updated: 12 May 2026 For updates, click on the ‘+’ sign below. 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…
Last updated: 11 May 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
Last updated: 4 March 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…
Last updated: 6 May 2026 To view updates, click on the ‘+’ sign below. The EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). EMA launched this pilot on 28 April 2026.…
Last updated: 5 May 2026 To view updates, click on the ‘+’ sign below: This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU. What is the definition of Product Information (PI) and…