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EMA releases functional specifications for EU Portal and EU Database to be audited

In October 2014, the European Medicines Agency (EMA) launched a public consultation on the draft functional specifications for the EU portal and EU database.  Stakeholders were invited to review these specifications and provide comments by 31 Oct 2014. Following this and final consultation by the European Commission and EU Member States, the functional specifications for the EU portal and EU database were released by the EMA on 19 Dec 2014.

The EU portal and EU database are required to support the harmonised approach to the submission, assessment and reporting of clinical trials established by the new Clinical Trials Regulation (EU) No. 536/2014. All information that is submitted via the EU portal will be stored in the EU database. The application of the Clinical Trial Regulation is conditional on the conduct of an audit of the EU portal and EU database to show that the system has achieved full functionality.  Thus, the aim of the document released by the EMA is to draw up the functional specifications to be audited. The legal basis for the audit of the EU portal and EU database can be found in the Clinical Trial Regulation which states the following:

  • The Agency [EMA] shall, in collaboration with the Member States and the Commission, set up and maintain a portal…as a single entry point for the submission of data and information relating to clinical trials. Data and information submitted through the EU portal shall be stored in the EU database.
  • The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a database. The EU database shall contain the data and information submitted in accordance with this Regulation [Clinical Trials Regulation].
  • The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the EU portal and EU database, together with the timeframe for their implementation.
  • The Management Board of the Agency shall, on the basis of an independent audit, inform the Commission when the EU portal and EU database have achieved full functionality and meet the functional specifications.

Source:  http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12/WC500179339.pdf


Lynsay McTaggart's profile is now available

Lynsay joined the TMQA team on 5 January 2015.  She has over 3 years` experience in Research Quality Assurance and specialises in GLP and GMP.  She is also a member of the Research Quality Association. 

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TMQA starts the new year by welcoming Lynsay McTaggart to the team

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This month`s TMQA Regulatory News Update includes:

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