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ICH M10 on bioanalytical method validation - Scientific guideline (updated)-2023/01/13
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Scientific guideline: ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions (FAQ) (updated)-2023/01/13
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ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline (updated)-2023/01/06
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Scientific guideline: ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5-2023/01/06
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Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated)-2023/01/05
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Regulatory and procedural guideline: Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised (...)-2023/01/05
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Regulatory and procedural guideline: EudraVigilance registration documents (updated)-2023/01/04
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Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)-2022/12/21
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Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)-2022/12/21
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Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)-2022/12/21
2022-12-21查看详情 >
