medicines-medical devices-regulatory affairs
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 25 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA has launched the Early Access to Medicines Scheme (EAMS) consultation. What is the EAMS scheme? How does the scheme work? EAMS is essentially…
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 EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained. About the SNSA pilot The EU Innovation Network started a…
The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs). Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products…
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…
The UK MHRA has updated its requirements and guidance for Phase I accreditation scheme for clinical trials. It has also provided a new phase I accreditation compliance checklist and variation form. What is the Phase I accreditation scheme? It is…
The TGA has published Version 1.0 of the Australian electronic submissions basics guide. The guide is entitled Australian electronic submission basics eCTD and NeeS Basics Who is the guide for? It is for users who are new to the TGA’s…