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Document: ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5-2025/10/10
2025-10-11查看详情 > -
Document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products-2025/1
2025-10-11查看详情 > -
Document: Annual report of the Pharmacovigilance Inspectors Working Group for 2024-2025/10/9
2025-10-10查看详情 > -
Document: Minutes of the CHMP written procedure 18-21 August 2025-2025/10/7
2025-10-08查看详情 > -
Document: Agenda of the CAT meeting 8-9 October 2025-2025/10/7
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Page: EU enlargement-2025/10/7
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Document: HMA-EMA joint Network Data Steering Group meeting - 16 September 2025-2025/10/7
2025-10-08查看详情 > -
Document: Agenda - Instrument for Pre-accession Assistance (IPA) training on assessing medicinal products in the EU: A practical introduction-2025/10/7
2025-10-08查看详情 > -
Document: Halocur : EPAR - Product Information-2025/10/7
2025-10-08查看详情 > -
Document: Halocur : EPAR - All Authorised presentations-2025/10/7
2025-10-08查看详情 >
