TMQA Latest News

EMA launches public consultation on application of the transparency rules of the Clinical Trials Directive

On 21 Jan 2015, the EMA launched a public consultation on how the transparency rules of the new Clinical Trials Regulation will be applied in the new EU clinical trial database. The Clinical Trials Regulation transforms the amount of information that is publicly available for each clinical trial conducted in the EU by requiring transparency on the authorisation, conduct and results of trials.

The new EU portal and EU database will provide the system that will be used to submit and maintain clinical trial applications and authorisations in the EU and will serve as the source of public information on the clinical trial applications assessed, and all clinical trials conducted in the EU.

While the EMA is responsible for the development and maintenance of the EU portal and EU database, it is the EU Member States that are responsible for authorisation and oversights of clinical trials in the EU. The public will be able to access detailed information about each trial with a summary of the results and a lay summary being published 12 months after the end of the trial.  For trials included in a marketing authorisation application in the EU, clinical study reports will be published 30 days after the procedure for granting the marketing authorisation has been completed or the application has been withdrawn.

The document under consultation sets out proposals for the application of the transparency rules of the European Clinical Trial Regulation for stakeholders to review and comment on. Comments are invited before 18 Feb 2015. The European Clinical Trial Regulation is distinct from the EMA’s policy on the publication of clinical trial data, which came into force in Jan 2015. Under the EMA’s policy, the EMA proactively publishes the clinical study reports submitted as part of marketing authorisation applications for human medicines. This means that the policy applies to clinical reports of studies that are beyond the scope of the European Clinical Trial Regulation as it, for example, also includes clinical trials that are conducted outside the EU but submitted to the EMA for marketing authorisation in the EU.

Source:  http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002253.jsp&mid=WC0b01ac058004d5c1


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

TMQA is pleased to announce that Lynsay McTaggart has joined us as an Associate. Lynsay joins us from the QA Department at BioReliance and she has worked previously at Scaled Solutions, Aptuit and Charles River Laboratories. Lynsay`s full profile will be available shortly.


TMQA Regulatory News Update - December 2014

This month`s TMQA Regulatory News Update includes:

  • MHRA Updates List of Phase I Accredited Units
  • EMA Classification and Analysis of GCP Inspection Findings
  • US Government Offers Legal Immunity to Ebola Vaccine Manufacturer
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