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. For ease of navigation, a tab has been added for each region (below). Click on the respective tab to view the news for…
Last updated: 25 May 2022 Updates are detailed at the end of this post. Report and minutes from the CMDh meeting held on 20-21 April 2022 The following four items (i – iv) are included in the report and minutes…
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.…
On mobile, the table below is best viewed by scrolling sideways. Title of guidance Type and level of guidance About the guidance Source Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases –…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-9 Summary of safety and performance Template Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall…
23 May Three shots of low-dose vaccine generates ‘strong immune response’ in kids under 5, says Pfizer Pfizer and BioNTech said they will ask the US FDA to authorise a three-shot regimen of their Covid-19 vaccine for children under five…
Last updated: 23 May 2022 Some Important dates in the calendar, from a regulatory perspective, are provided in the tables below. This post will be updated on an ad hoc basis. On mobile, the tables are best viewed by scrolling…
Pharmaceutical committee meeting of 11 May The 99th meeting of the committee was held on 11 May. Whilst a summary record of the meeting is not yet available, it is worthwhile viewing the agenda and the document for discussion. The…
This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…
This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information under each…