Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)-2023/7/31

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(update)-2023/7/31

Scientific guideline: Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies-2023/7/31

Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes-2023/7/25

Regulatory and procedural guideline: Guidance document on voting in the framework of discussion and adoption of CHMP opinions-2023/7/26

Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information-2023/7/13

Guidance on good manufacturing practice and good distribution practice: Questions and answers-2023/7/13

ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline-2023/7/19

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2023/7/5

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes-2023/7/5