medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
This post covers international regulatory news in brief. It will be updated on an ad hoc basis. To ease navigation, tabs have now been added for each region. Latest updated section(s): EU (Finland), Oceania (Australia) Photo by Markus Winkler on Unsplash
Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) Draft Level 2 revised guidance This draft…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Other news including on vacinnes, treatments, trials and side effects, here. Company(ies)/Others Product Issuing regulatory agency or organisation…
The UK MHRA is updating regulations applying to software and artificial intelligence (AI) as a medical device. The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health…
CMDh contact points The list of CMDh contact points has been updated and is available for download on this page. CMDh Draft agenda for the meeting of 14-16 September 2021 The draft agenda for the meeting is available here.
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 marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…
The UK MHRA is consulting on the future regulation of medical devices in the UK. Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in…
The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…
Swissmedic has published an eight page position paper on Decentralised Clinical Trials (DCTs) with medicinal products. This position paper could be of interest amongst other, to anyone who has an interest in the increasing digitisation and/or digitalisation of clinical trials.…
Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source ICH Q12: Implementation Considerations for FDA-Regulated Products Draft, Level 1 revised guidance This guidance should be read in conjunction with ICH…