RIS.WORLD - Information réglementaire des industries de santé

24 juin 2025

MEDICAMENTS

Europe

UK – GSK’s Blenrep combination recommended by NICE to treat multiple...

Pamela Cronin Bartolini - 16/06/2025

The health technology assessment agency has recommended in draft guidance that the antibody-drug conjugate be used on the NHS alongside bortezomib plus dexamethasone (BVd)...

Europe – PRAC concludes eye condition NAION is a very rare...

16/06/2025

NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

UK – NHS first in world to roll out new ‘trojan...

16/06/2025

France – Lévothyrox® : deux nouveaux dosages arrivent !

16/06/2025

USA – FDA drafts guidance, orders on minor changes to OTC...

11/06/2025

DISPOSITIFS MEDICAUX

DM DIV Europe

Europe – MDCG 2025-5 Questions & Answers regarding performance studies of...

Pamela Cronin Bartolini - 18/06/2025

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR)....

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Update MDCG 2019-11 rev.1 – Qualification and classification of...

18/06/2025

UK – First major overhaul of medical device regulation comes into...

17/06/2025

Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2025-4 Guidance on the safe making available of...

17/06/2025

UK – MHRA releases spate of new guidelines on decentralized manufacturing

11/06/2025

COSMETIQUES

DM DIV Europe

Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...

Pamela Cronin Bartolini - 20/12/2024

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of...

Trois nouvelles guidances du MDCG en Mars 2020

Europe – MDCG 2019-13 Guidance on sampling of MDR Class...

17/12/2024

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Interface between the Regulations on clinical trials of medicinal...

17/12/2024

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Commission launches a public consultation and a call for...

17/12/2024

MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical Devices Regulatory Reform – Roadmap to implementation –...

17/12/2024

SANTE PUBLIQUE

Santé Publique

France – Les laboratoires connaissaient les dangers depuis 2000″ : un...

Pamela Cronin Bartolini - 18/06/2025

Une patiente souffrant de méningiomes (tumeurs au cerveau) attribués au médicament Androcur a obtenu sur décision de la justice civile à Poitiers plus de...

HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – Cytomégalovirus (CMV) chez la femme enceinte : la HAS...

18/06/2025

France – Le gouvernement dévoile un plan pour la santé mentale

16/06/2025

Europe – European Commission hints at delaying the AI Act

16/06/2025

Europe – 2024 annual report is published

11/06/2025

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