EMA Moves to Adopting Policy on Publishing Clinical Trial Data

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-12-2014 14:01


The European Medicines Agency (EMA) Management Board on June 12, 2014 moved to finalize its policy on publication of clinical trial data with the addition of more user-friendly amendments proposed by EMA Executive Director Guido Rasi. Subject to final adoption by the EMA Management Board by mid-July 2014, the policy will allow EMA to publish clinical trial data that are submitted as part of marketing authorization applications and allow users to download, save, and print the trial data for academic and non-commercial research purposes.

In light of discussions at the board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalized with a view to its adoption by the board through written procedure by mid-July 2014, and will be effective from October 1, 2014. The agency said it will ensure that the policy will not prejudice citizens’ rights under existing access-to- documents legislation and the new clinical trials regulation.

"Since embarking on its plans for the proactive publication of clinical trial data, the agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests," said EMA in a statement. "After an extensive consultation phase that took place between June and September 2013, the agency carried out a second round of targeted consultation in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access. The agency’s policy is an important step forward toward achieving increased transparency in the regulation of medicines in Europe. It takes the agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines."

In a separate development, the EMA's Management Board also adopted a revised process for assessing the eligibility of patients’ and healthcare professionals’ organizations to provide input to the agency on general issues related to medicines. This process allows the agency to identify the most appropriate organizations acting in the interests of European civil society. The eligibility criteria have been updated to align with increased transparency requirements, in particular on sources and level of funding, and a code of conduct on their relationship with pharmaceutical industry.

In another development, the Management Board endorsed a proposal for the creation of an ad hoc Working Group on Veterinary Novel Therapies (ADVENT). The working group will address the need expressed by stakeholders for more guidance on new classes of veterinary medicines, such as cell therapies, monoclonal antibodies, and bacteriophages. ADVENT will be composed of a small core group of experts that can be supplemented with groups of experts in the specific scientific area covered by the new guidance document. This initiative is in line with the agency’s efforts to support development of innovative medicines. It follows the start of the agency’s Innovation Task Force in in November 2013 to provide support to veterinary medicines during the early stages of their development.

The Management Board also gave a positive assessment of the agency’s operations in 2013, and of its management and internal control system. This analysis and assessment of the Executive Director’s annual activity report is carried out by the board annually as required by the Financial Regulation.The analysis highlights, among other topics, the agency’s initiatives toward stronger interaction with health technology assessment bodies to facilitate patients' access to medicines and the agency’s new organizational structure designed to better support the scientific work of the EMA's committees, improve partner and stakeholder relations, and facilitate data-sharing among the European medicines regulatory network.

Source: EMA


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription