OTC Medicines

EMA RWD Report

The European Medicines Agency (EMA) has published a third report based on studies EMA conducted using real-world data (RWD) between February 2024 and February 2025. The report summarises the progress made to enable the use of RWD and establish its value in regulatory decision-making.

EMA RWD Report

EMA Consultation on the ICH M4Q(R2) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (step 2b)

The European Medicines Agency (EMA) has published for public consultation the ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality (step 2b). The consultation closes on 24 October 2025.

EMA Consultation on the ICH M4Q(R2) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (step 2b)
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