medicines-medical devices-regulatory affairs
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 8 May 2020 – 23 September 2021 is covered. On mobile, the table is best…
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 UK MHRA is seeking views on innovative medicines manufacture at point of care. It has launched a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing. What is POC manufacturing? POC manufacturing refers to the manufacture…
Health Canada is consulting on revised guidance of Post-Notice of Compliance (NOC) Changes – Quality. Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality have been released for stakeholder consultation. Who is the focus of the consultation?…
Last updated: 2 October 2024 See update at the end of the post. The European Medicines Agency (EMA) issued a draft guideline in August for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPs containing…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…
This post is an attempt to provide the requirements for conducting clinical trials in the UK post Brexit i.e. since 1 January 2021. The information provided is by no means exhaustive.. Please refer to the resources at the end of…
The UK MHRA has issued new guidance on authorisations and procedures required to Import Investigational Medicinal Products (IMPs) from countries on a list, to Great Britain (GB). Information is also provided on the importation of authorised/unathorised: non-investigational medicinal products unmodified…
The UK MHRA has published its new Delivery Plan 2021-2023. The plan has one overarching goal which is to deliver for patients and the public. The new plan is designed to bring together and prioritise the MHRAs existing efforts in…
Last updated: 14 January 2022 See update(s) at the end of the post. The Medical Devices Regulation (EU) 2017/745 (MDR) requires require manufacturers to draw up a Summary of Safety and Clinical Performance (SSCP) for their devices. This post attempts to…
Health Canada has implemented ICH Guidance Q3C(R8): Impurities: Guideline for Residual Solvents. Q3C(R8) was developed by the appropriate ICH Expert Working Group. It has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly…
What are the implications of the new Medical Devices Regulation (EU) 2017/745 (MDR) becoming applicable, for Switzerland? Until 26 May 2021, Switzerland had been participating in the European Union (EU) internal market for medical devices through a specific chapter of…