This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]
Changes have occurred in the organisation and procedural activities of the China Food and Drug Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed to [...]
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]
The regulatory agencies in South East Asia and the Western Pacific share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new [...]
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 [...]