Regulatory information – Updated SME user guide now available

News 19/10/2016

New sections have been added to the guide

The European Medicines Agency (EMA) has updated its PDF iconuser guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector.

The guide aims to support SMEs to better understand the EU legislative framework relating to medicines and the requirements for the development and authorisation of medicines for human or veterinary use.

SMEs often have limited experience with regulatory procedures and the guide provides an overview of data requirements to support a marketing authorisation, as well as the regulatory tools available to facilitate medicines' development. The guide, which follows the chronological stages of developing a medicine, has been completely revised to clarify existing sections and add new ones relating to:

Any feedback on the contents of this guide should be forwarded to the SME office: sme@ema.europa.eu.

The SME Office was set up within EMA to address the particular needs of smaller companies. The office has dedicated personnel who can help SMEs by:

  • responding to regulatory and administrative enquiries;
  • setting up briefing meetings to discuss a regulatory strategy;
  • organising workshops and training sessions.

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