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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access

Europian regulatory guidelines

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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing-authorisation applications for human medicines. Guidelines provide a basis for practical harmonisation of how the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy that are in the Community directives.

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Clinical Research and Regulatory Affairs, Generics and biosimilars initiative Journal

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