medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
1 July Global regulators agree on key principles on adapting vaccines to tackle virus variants On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during…
Last updated: 1 July 2022 See updates at the end of the post. 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…
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…
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 Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Draft guidance This guidance (Guidance 3)…
Last updated: 29 June 2022 Report from the CMDh meeting held on 21-22 June 2022 The following items are included in the report from the above meeting: i) Request form for MRP/RUP for Medicinal Products for HumanUse The CMDh has…
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0862 on Regulations.gov. …
The UK government has responded to the medical devices consultation (the original consultation is half way down the page) held between September and November 2021, with new plans to strengthen the regulation of medical devices in the UK. Following the…
This post is an attempt to provide an information resource for Advance Therapy Medicinal Product (ATMPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timelycompliance with MDR requirements From 27 May 2024, the MDR will be fully applicable…