International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
International – ICH adopts E6(R3) guideline on good clinical practices
The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical...
Europe – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms...
International – Mpox : l’OMS approuve un second vaccin, fabriqué par une société pharmaceutique...
Un nouveau vaccin contre la mpox, fabriqué par la société pharmaceutique japonaise KM Biologics pour un usage d’urgence, a été approuvé, mardi 19 novembre, par...
International – Industry stakeholders call for changes to ICH M14 RWD guideline
Pharmaceutical industry stakeholders from both sides of the Atlantic generally supported the International Council for Harmonization’s (ICH) M14 guidance on using real world data...
India – National Regulatory Authority of India meets WHO international standards for vaccine regulations
The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet...
International – The ICH E11A Guideline reaches Step 4 of the ICH Process
The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. The E11A Guideline
provides...
International – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...
International – VIH : un médicament préventif efficace, avec deux injections par an seulement,...
C’est un « moment historique » s’est réjoui, mercredi 24 juillet, le professeur Yazdan Yazdanpanah, directeur de l’Agence nationale de recherche sur le sida-maladies infectieuses émergentes. Mais...
International – WHO publishes guidance for HPV vaccine developers to help tackle cervical cancer
Currently the main cause of cervical cancer – the fourth most common cancer in women globally – HPV is a very common group of...
