medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 12 Mar 2024 MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) When a sponsor of a clinical investigation submits an application according to article…
Last updated: 5 March 2024 See updates at the end of the post. Q&A – Pharmacovigilance Legislation Regulation (EU) No 1235/2010 and Directive 2010/84/EU updated The above document has been updated. Here, you can view the track changed and clean…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
Last updated: 23 February 2024 See updated at the end of the post. On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an…
Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…
Last updated: 17 March 2025 To view updates, click the ‘+’ sign below See updates at the end of this post. Following an announcement in May 2023, the pilot phase of the Innovative Devices Access Pathway (IDAP) was launched on…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 14 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
Last updated: 7 February 2024 See updates at the end of the post. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of…
Last updated: 1 February 2024 See updates at the end of the post. Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Here, you can view the track changed (September 2023) and clean…
Last updated: 31 January 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 12-14 December 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
This post concerns a recent court case in which an EU Supplementary Protection Certificate manufacturing waiver was put to the test in a Munich court. About Supplementary Protection Certificate (SPC) manufacturing waivers With the entry into force of Regulation (EU) 2019/933 on…
This post is an attempt to present some of the salient information from Case C-473/22 concerning Mylan vs Gilead on potential Supplementary Protection Certificate (SPC) infringement. The information provided below is by no means exhaustive. In order to develop a…