External study
21 Jun 2024
The Value of Reference Agency Assessment Reports in Enabling Regulatory Reliance
Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was reviewed by the reference NRA, provides a rationale for decision making and promotes confidence and trust. The Centre for Innovation in Regulatory Science (CIRS) has published...
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Statement
21 May 2024
Pharmaceutical trade associations welcome latest announcement of largest number of regulatory agencies recognized under the WHO Listed Authorities Framework
On 21 May, pharmaceutical trade associations at international, European and US-level have welcomed the recognition of the European Medicines Regulatory Network (EMRN) and the United States Food and Drug Administration (FDA) as WHO Listed Authorities, as well as the expanded scope of functions of the Health Sciences Authority (HSA) of Singapore.
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Position paper
8 Feb 2024
Regulatory agilities applied to vaccines during the COVID-19 pandemic and recommendations for the future
This position paper outlines some key regulatory agilities implemented in areas such as research and development, regulatory evaluations, authorizations, and post-approval changes (PACs) and labelling. Key learnings and recommendations to enhance regulatory frameworks in the future are also included.
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