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Scientific guideline: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates-2023/4/5
2023-04-06查看详情 > -
Scientific guideline: Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurised metered dose inhalers-2023/4/5
2023-04-06查看详情 > -
Scientific guideline: Guideline on influenza vaccines – submission and procedural requirements (Rev.2)-2023/4/3
2023-04-06查看详情 > -
Regulatory and procedural guideline: Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2023/2024-2023/4/3
2023-04-06查看详情 > -
Regulatory and procedural guideline: Guideline on computerised systems and electronic data in clinical trials-2023/03/10
2023-03-10查看详情 > -
Regulatory and procedural guideline: Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy-2023/03/01
2023-03-01查看详情 > -
Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008-2023/02/27
2023-02-27查看详情 > -
Scientific guideline: Guideline on plasmid DNA vaccines for veterinary use-2023/02/24
2023-02-24查看详情 > -
Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation-2023/02/15
2023-02-15查看详情 > -
Regulatory and procedural guideline: Validation checklist for Type II quality variations (updated)-2023/02/10
2023-02-10查看详情 >