In 2001, CMR International conducted a study among pharmaceutical companies to evaluate their experience with regulatory authorities in Asia Pacific regarding the acceptance of foreign clinical data and adoption [...]
The ICH E5 Guideline was introduced in February 1998 and subsequently implemented by the regulatory authorities of the USA, EU and Japan. The purpose of this guideline is to [...]
CMR International R&D Briefing 31 - Profile of performance: Review times - is there still room for improvement? Key messages: Performance improvement initiatives established by regulatory authorities in the [...]