medicines-medical devices-regulatory affairs
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…
The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices. The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I…
The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…
Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs). Why is Health Canada consulting on this policy? Health Canada is updating its policy on DDCPs to provide more detail and clarity…
The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines. Module 1.2.1: Application form This application form must be used for the following Category 1 and COR…