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Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)-2023/01/26
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Regulatory and procedural guideline: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction (…)-2023/01/18
2023-01-18查看详情 > -
Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7 (updated)-2023/01/18
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Regulatory and procedural guideline: European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form (updated)-2023/01/16
2023-01-16查看详情 > -
Regulatory and procedural guideline: Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency (updated)-2023/01/16
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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
2023-01-05查看详情 >