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EMA Guidelines

Meaning

EMA Guidelines refer to the authoritative, scientifically-grounded recommendations and regulatory documents issued by the European Medicines Agency (EMA), the agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. These guidelines establish the standards for quality, safety, and efficacy that pharmaceutical companies must meet when developing and applying for authorization of medicinal products. Adherence to these guidelines ensures a consistent, high level of public health protection across the EU member states.