Asia

CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies

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 [...]

2024-12-18T16:22:05+00:00February 21st, 2024|Tags: , , , |

Measuring time to market for new medicines in 7 Asian countries between 2016-21, following review by US FDA or EMA

During the DIA Global Annual Meeting 2023, Adem Kermad, Magda Bujar and Neil McAuslane developed and presented a poster in which they shared the results, recommendations and conclusions about [...]

2024-04-12T09:04:51+00:00August 15th, 2023|Tags: , |

Liu et al 2013 – Characterising Good Review Practices across APEC agencies

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 [...]

2024-12-18T16:21:25+00:00December 1st, 2013|Tags: , |

CIRS RD Briefing 37 – Adoption of ICH E5 in Asia Pacific

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 [...]

2024-12-18T16:21:49+00:00December 1st, 2002|Tags: , |
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