medicines-medical devices-regulatory affairs
Below is an attempt to provide information with the intention of facilitating a better understanding of the progress with the update to the EU pharmaceutical legislation. The proposed revision of the pharmaceutical legislation will consist of two legislative proposals: The…
Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…
Last updated: 1 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA offers a pre-submission service before applying for medicines Marketing Authorisations. For International recognition For New Active Substances and/or complex applications For ACCESS and…
AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines. In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for…
Last updated: 4 October 2022 See updates at the end of the post. Swissmedic has provided practical interpretation on the requirement of an authorised representative (CH-REP) for drug-device combination products. Swiss authorised representative (CH-REP) The revision of the Medical Devices…
The TGA, Australia has published a checklist for manufactures of medical devices to demonstrate compliance with the essential principles for their medical devices. TGA states that it is the manufacturer’s responsibility to demonstrate compliance with the essential principles for their…