RIS.WORLD

MEDICAMENTS

Europe

Europe – EMA reviewing data on sabizabulin for COVID-19

RIS.WORLD - 28/07/2022

EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19. The review will look at all available...

International – ICH M10 on bioanalytical method validation

28/07/2022

New guidance on biologics affects authorized generics

USA – FDA guidance focuses on Real-Time Oncology Review program

25/07/2022

USA – FDA describes plans to expand remote regulatory assessments

25/07/2022

Europe – EMA recommends restricting use of cancer medicine Rubraca

23/07/2022

DISPOSITIFS MEDICAUX

Seegene's COVID-19 test authorized for emergency use in Korea

Asie-Pacifique

South Korea – MFDS rules on medical device insurance and designated...

RIS.WORLD - 28/07/2022

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations. The announcements include: ...

Spain – AEMPS-affiliated notified body becomes first Spanish group designated under...

26/07/2022

Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan updates guidance on QMS Conformity Survey applications

23/07/2022

Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical...

22/07/2022

$France – Emballages de dispositifs médicaux : le LNE accrédité Cofrac$

France – Emballages de dispositifs médicaux : le LNE accrédité Cofrac

20/07/2022

COSMETIQUES

SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Europe

Europe – Règlement 2022/1181 : nouvelles règles d’étiquetage pour les produits...

RIS.WORLD - 22/07/2022

Le Règlement 2022/1181 du 8 juillet 2022, publié au Journal officiel de l’Union européenne le 11 juillet, vient modifier le préambule de l’Annexe V...

USA – « Global harmonization »: Review of regulation around the cosmetic world

21/07/2022

Brazil – Consensus en faveur d’une interdiction fédérale des tests sur...

12/07/2022

Information on Cosmetic Packaging Materials in the Context of the EU Cosmetics Regulation EC 1223/2009

Europe – Cosmetics Europe veut un Règlement cosmétique basé sur la...

06/07/2022

Europe – Upcoming changes to REACH information requirements

26/05/2022

SANTE PUBLIQUE

Santé Publique

Europe – EMA response to the monkeypox public health emergency

RIS.WORLD - 28/07/2022

The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization...