medicines-medical devices-regulatory affairs
Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…
Last updated: 28 November 2023 See updates at the end of the post. In September 2021, the European Medicines Agency (EMA) provided final feedback to the European Commission (EC) on its request to evaluate the impact of the removal of…
Last updated: 13 July 2024 To see updates, click on the ‘+’ sign below On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.…
Last updated: 2 June 2023 See updates at the end of the post. “Blue – Box” requirements “Blue – Box” requirements concern additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of…
The Commission today welcomed the launch of the Unitary Patent system. About the Unitary Patent system The Unitary Patent system: What are the main advantages of the Unitary Patent System The main advantages of the new Unitary Patent system are:…
Last updated: 28 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 24-26 January 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 6 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 13-14 December 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
On 6 January 2023, the European Commission adopted a proposal allowing more time to certify medical devices to mitigate the risk of shortages. The proposal: Further details are provided below. What does the length of the proposed extension period depend…
Last updated: 20 December 2022 See updates at the end of this post. Report and minutes from the CMDh meeting held on 8-10 November 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published Version 1.0 of the recommendation paper on decentralised elements in clinical trials . The 33 page document was adopted by the Accelerate Clinical Trials in…