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European Union: EMA publishes revised user guide for micro, small and medium-sized enterprises in the pharmaceutical sector

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In brief

On 23 January 2024, the European Medicines Agency (EMA) published an updated version of the user guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

Key takeaways

In particular, the new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines providing an overview of the Clinical Trial Regulation and Clinical Trials Information System (CTIS) and offering insights into the Medical Devices Regulation for human medicines.

The guide has also been supplemented with additional sections/subsections on (i) IT systems, which provide an overview of common platforms, systems, and databases for application submission, data management, and secure communication with EMA/EU network, (ii) Borderline Products, (iii) the Environmental Risk Assessment, whose purpose is to investigate the potential environmental risk of the medicinal product following its use in patients, and (iv) the use of Big Data for decision making.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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