Major update of the SME user guide from EMA
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
The revised user guide offers comprehensive information on the European Union (EU) legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use.
It follows the chronological stages of medicine development, and has become a reference source of information for SME and academic developers, supporting them to navigate the system of medicine regulation in the EU. The new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines:
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