Algae related regulation & legislation

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algae:pharma_medical

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algae:pharma_medical [2026-09-13 21:48] – [Human Medicines Directive] robertalgae:pharma_medical [2026-09-14 00:40] (current) – [Good Manufacturing Practice (GMP)] robert
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 The European Pharmacopoeia establishes quality standards (identity, purity, assay) for pharmaceutical-grade algal materials. Compliance with Ph. Eur. monographs is expected by regulatory authorities and buyers in the pharmaceutical supply chain. The European Pharmacopoeia establishes quality standards (identity, purity, assay) for pharmaceutical-grade algal materials. Compliance with Ph. Eur. monographs is expected by regulatory authorities and buyers in the pharmaceutical supply chain.
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 +=== Forthcoming changes ===
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 +Following years of negotiations, the final texts of the new EU Pharma Package (Directive and Regulation) were officially published in early 2026. [[https://dlrcgroup.com/updates-to-the-eu-pharmaceutical-reform-2026/|HSFKramer]]. This package will fully replace and repeal Directive 2001/83/EC and Regulation (EC) No 726/2004 once it takes full effect (expected around 2028).
  
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algae/pharma_medical.1789336110.txt.gz · Last modified: by robert