EMA updates user guide for SMEs in the pharmaceutical sector

The European Medicines Agency (EMA) has published a revised version of its User Guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector.

The User Guide provides an introduction to the EU legal framework for medicinal products and covers the requirements for the development and authorisation of medicinal products for human and veterinary use. 

The user guide follows the chronological stages of drug development from preclinical research to post-authorisation activities. 

The updated User Guide now reflects the major changes that the EU legal framework for human and veterinary medicine has undergone in recent years, including, for example:

  • The new Veterinary Medicinal Products Regulation, which among other things aims to standardise the use of veterinary medicines in the EU
  • The Clinical Trials Regulation which establishes a single portal and database for the submission and assessment of clinical trial applications (CTIS)
  • The Medical Device Regulation, which seeks to strengthen patient safety and the availability of new devices

Other key additions to the User Guide include, for example, information on:

  • IT systems, platforms and databases used for the submission of applications, data processing and secure communication with the EMA and EU networks
  • Guidance on borderline products that are difficult to fit into the legal framework
  • Environmental risk assessments, including the requirements to investigate potential environmental risks arising from the use of medicinal products
  • Use of "big data" in decision-making processes

Read the updated user guide from EMA

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