WHO Guidelines Call For Enhanced Protections for Clinical Trial Participants

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The World Health Organization (WHO) has released new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics that impact clinical trial operations.

Drugs used in clinical trials should be made to be compliant with GMPs “as appropriate to the stage of development,” the WHO says in the guidelines.

The WHO further says that, “to ensure the safety of the subjects participating in clinical trials; and to ensure that the results of clinical trials are unaffected by inadequate safety, quality, or efficacy arising from unsatisfactory manufacture, investigational products should be manufactured and managed in accordance with an effective quality management system and the recommendations contained” within the document.

Comments are due August 31, 2021, and can be sent to Steve Estevão Cordeiro, Technical Officer, WHO Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (estevaos@who.int), with a copy to Sinead Jones (jonessi@who.int).

Edited by Michael Causey