medicines-medical devices-regulatory affairs
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…
Last updated: 13 September 2026 To view updates, click on the ‘+’ sign below. What are combined studies? Combined studies can be understood as studies that involve: What is COMBINE initiative? COMBINE is one of the initiatives highlighted in the Draghi…
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 2 Sep 2026 Evaluation of Therapeutic Equivalence This guidance provides information regarding FDA’s therapeutic equivalence…
Last updated: 23 September 2026 To view updates, click on the ‘+’ sign below. Updated PLM Portal eAF Release notes now available An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF…
Last updated: 20 August 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…
Date Event Further information 16 Dec 2025 The EU commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices The details of the Commission Proposal are discussed in this post1. 1 July 2026…
Last updated: 13 August 2026 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
Last updated: 7 August 2026 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots, search engines and other AI based software. Chatbot/search engine Company…
Last updated: 5 August 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in an easy to understand…