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

28 Feb 2024    1 minute read
Sectors Healthcare & Life Sciences

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.

Contents

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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