Major update of the SME user guide

23 January 2024

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 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:

• Veterinary Regulation: the document has been fully revised to align with the veterinary regulation
• Clinical Trials Regulation (new section 4.4): provides an overview of the clinical trial regulation and Clinical Trials Information System (CTIS)
• Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines

Other important new sections/subsections include:

• IT Systems (section 1.3): An overview of common platforms, systems, and databases for application submission, data management, and secure communication with EMA/EU network
• Borderline Products (section 3.6): Guidance on products with regulatory framework uncertainty
• Environmental Risk Assessment (ERA) (section 4.2.4): Requirements to investigate potential environmental risks of a medicinal product following its use in patients
• Big Data (section 4.3.6): Guidance on utilising big data for decision making
• 'EU-M4all' (section 6.16): Guidance for access to high-priority medicines for patients outside of the EU
• 'OPEN' Initiative (section 6.17): Information on EMA collaboration with non-EU regulators in the scientific evaluation of certain medicines

For feedback on the guide, contact the SME Office at [e-mail].

Recognising SMEs as vital sources of innovation, EMA has a dedicated SME Office to support smaller companies. The office provides assistance for regulatory and administrative enquiries, sets up regulatory strategy discussions, and organises workshops and training sessions.
 

Related documents

User guide for micro, small and medium-sized enterprises

Adopted

Annex - National provisions for SMEs applicable to the pharmaceutical sector