medicines-medical devices-regulatory affairs
Last updated: 29 October 2026 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: 28 October 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: 22 October 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…
About the pilot program The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches (namely leveraging QRIs and a new rolling review process) for accelerating first-in-human (FIH) clinical trials in the United…
Last updated: 10 October 2026 See history of updates below This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign…
Last updated: 6 October 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: 30 September 2026 To see updates, click on the ‘+’ sign below. The MHRA has published guidance on a Phase 1, 14-day pilot programme for clinical trials. Below is an attempt to present the information in a Q&A…
Last updated: 28 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: 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…
Last updated: 13 September 2026 To view updates, click on the ‘+’ sign below. About COMBINE In the EU, there are legal requirements for the individual authorisation processes of: Regulations clinical trials of medicinal products Regulation (EU) 536/2014 on clinical…
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…