Evaluating and publicly designating regulatory authorities as WHO listed authorities: policy document
jun 2021 · World Health Organization
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This policy on the evaluation and designation of regulatory authorities as WHO listed authorities (WLA) was
developed following broad public consultation and the review of written comments received from the
publication of a concept note, which informed the drafting of a first version of the WLA policy and
operational guidance, as well as international consultative meetings with Member States and interested
stakeholders. It also considers recommendations from the fifty-second meeting of the World Health
Organization Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) on the
replacement of the term “stringent regulatory authority” with “WHO listed authority”. The ECSPP
recommendations were based on comments received on the proposed elements of a replacement
definition for Stringent Regulatory Authorities (SRAs) posted by WHO for public comment in August
2017 that was intended to provide a more transparent, robust and equitable measure of regulatory
performance.
developed following broad public consultation and the review of written comments received from the
publication of a concept note, which informed the drafting of a first version of the WLA policy and
operational guidance, as well as international consultative meetings with Member States and interested
stakeholders. It also considers recommendations from the fifty-second meeting of the World Health
Organization Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) on the
replacement of the term “stringent regulatory authority” with “WHO listed authority”. The ECSPP
recommendations were based on comments received on the proposed elements of a replacement
definition for Stringent Regulatory Authorities (SRAs) posted by WHO for public comment in August
2017 that was intended to provide a more transparent, robust and equitable measure of regulatory
performance.
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