International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
France – Monkeypox : la HAS complète ses recommandations sur la vaccination
Pour faire face à l’épidémie de Monkeypox, la HAS avait recommandé le 8 juillet dernier une vaccination préventive pour les groupes les plus exposés au...
France – La HAS publie le référentiel de certification des logiciels d’aide à la...
La Haute autorité de santé (HAS) a publié le 29 septembre le référentiel de certification par essai de type des logiciels d'aide à la...
USA – Experts call for federal incentives to promote clinical trial diversity
A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of...
Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
France – Le logiciel officinal Pharmony One obtient l’agrément Sesam-Vitale
Pharmony One, solution de gestion d'officine en mode SaaS (software as a service, logiciel en tant que service) a décroché l'agrément Sesam-Vitale Addendum 8,...
USA – Sentinel System expands capacity, data linkages, report indicates
The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions...
Europe – EMA Management Board: highlights of October 2022 meeting
COVID-19
At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to...
International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on...
The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use...
