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...
International – ICH announces forthcoming documents on nitrosamine impurities, RWD
The International Council for Harmonisation (ICH) announced plans to issue two new documents: an addendum to the M7 guideline on assessing carcinogenic risk that...
International – ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance...
The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and...
International – WHO recommends risk management plans for high-risk excipients
The World Health Organization (WHO) has released two draft appendices to a recent draft guideline on good manufacturing practices (GMPs) for excipients. The first...
International – WHO issues guidance on nitrosamine controls in drug manufacturing
The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination...
