medicines-medical devices-regulatory affairs
Last updated: 28 September 2026 To view updates, click on the ‘+’ sign below. New version of the eSubmission Gateway XML delivery file to enable future inclusion of ePI details From 2 October 2026, the eSubmission Gateway XML delivery file…
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: 25 September 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: 24 September 2026 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…
Last updated: 24 September 2026 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: 22 September 2026 To see updates, click on the ‘+’ sign below. The MHRA has today published guidance on a Phase 1, 14-day pilot programme for clinical trials. Below is an attempt to present the information in a…
Last updated: 17 September 2026 To view updates, click on the ‘+’ sign below The MHRA offers a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after 3rd April…
The U.S. FDA today announced the final design of the Expedited Investigational New Drug (IND) Pilot. What does the pilot aim to achieve? Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug…
The EMA is inviting marketing authorisation applicants to take part in an 18-month pre-submission interactions (PSI) model pilot. When did EMA launch the pilot? The pilot was launched in September 2026 The pre-submission interactions (PSI) model pilot introduces shared ownership and early dialogue…
Date Guidance No About the guidance Sept 2026 MDCG 2020-16 rev.5 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) The changes are as follows:Rule 7 : Clarification of the rationale and revision…
Last updated: 3 September 2026 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 31 Aug 2026 Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and…