The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions.
The framework, first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency and industry stakeholders around human and veterinary medicines, though industry questions on a specific product and/or regulatory procedure will still be handled by the relevant EMA operational departments.
Comments on the framework from the European Commission were overall supportive, according to the management board, and address the framework’s emphasis on transparency and a call for multi-stakeholder dialogue.
Now that the management board has signed off on the framework, according to minutes of its meeting released Monday, EMA will implement an action plan that foresees establishing criteria for classification of industry associations, updating the agency’s stakeholder database and launching a new website that will help with the monitoring and annual reporting to the board on interactions with industry associations.
Clinical Trial Transparency Update
As far as progress on implementing the EMA policy on the publication of clinical data, the management board meeting noted that progress is being made on five workstreams: data receipt and filing, redaction consultation, publication, presentation and management of the external users.
In addition, three new guidance documents -- on redaction of commercially confidential information (CCI), on anonymization, and on the submission of clinical data for publication -- have been prepared and are almost finalized.
“The guidance on CCI will include information on what is not CCI. Concerning the anonymisation of personal data, the Agency recommendation will be to strive for as much clinical utility of the data whilst ensuring protection of personal data, hence facilitating secondary analysis of the data. Companies will be expected to file an anonymisation report (to be equally published) along with the clinical reports,” according to the minutes.
The management board also discussed the development of the clinical trial portal and database, which will allow a number of stakeholders to complete a wide range of processes on the same system.
An agreement with Member States on timelines will be sought in October and November and the current timeline “foresees the auditable release to be available in Q3 2016, the audit to be carried out November 2016 to February 2017 in order to submit the audit result to the board at the March 2017 meeting.”
Minutes of the 89th Meeting of the Management Board