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Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 5 - Revision 1-2023/02/06
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Clinical evaluation of new vaccines - Scientific guideline (updated)-2023/02/01
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Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products(…)-2023/01/31
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Other: Question and answer document on the Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016)-2023/01/27
2023-01-27查看详情 > -
Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline (updated)-2023/01/27
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Scientific guideline: Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy-2023/01/27
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Scientific guideline: Guideline on clinical evaluation of vaccines - Revision 1-2023/01/27
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Scientific guideline: Reflection paper on resistance in ectoparasites-2023/01/27
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Procedural advice for vaccine platform technology master file (vPTMF) certification - Scientific guideline (updated)-2023/01/27
2023-01-27查看详情 > -
Scientific guideline: Procedural advice for vaccine platform technology master file (vPTMF) certification-2023/01/27
2023-01-27查看详情 >