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 [...]

CIRS RD Briefing 56: Understanding the dynamics of China’s regulatory environment

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 [...]

2022-05-04T09:06:07+00:00June 1st, 2015|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 [...]

2021-01-22T15:07:49+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 [...]

2021-02-12T12:09:24+00:00December 1st, 2002|Tags: , |
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