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Added in May 2023 22 May NEW -…

Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”  UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines UPDATE [...]

Por |2023-04-24T12:41:55+00:00abril 24th, 2023|Noticias|Sin comentarios

The ICH M7(R2) Guideline reaches Step 4 of the ICH Process

The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023.

Por |2023-04-06T00:00:00+00:00abril 6th, 2023|Noticias|Sin comentarios

CMDH PRESS RELEASES 2023

Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February 2023 Report from the meeting held on 24-26 January 2023

Por |2023-01-27T15:20:02+00:00enero 27th, 2023|Noticias|Sin comentarios
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