The World Health Organization is preparing to introduce its new framework for designating national regulatory agencies as “WHO-Listed Authorities” (WLAs) – those that meet WHO and internationally recognized standards and guidelines as well as following good regulatory practices.
WHO’s New Regulatory Benchmarking Framework To Go Live This Year
Egyptian And Nigerian Agencies Reach ‘Maturity Level 3’
A new list of national regulators that want to be seen as meeting the highest international regulatory standards has been drawn up by the WHO in a drive to foster regulatory convergence and harmonization.
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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
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While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.