For the first time, Europe can enjoy a consistent approach to identifying commercially confidential information and personal data in marketing authorization applications. The move comes after the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) decided to implement a joint guidance document, which is a key step in achieving transparency.

Regulatory authorities in the European Economic Area (EEA) will in future adopt the same methods to identify which parts of an application dossier can or cannot be released in response to access to documents requests, regardless of whether the medicine in question has been authorized by centralized, decentralized or mutual recognition procedures.

The scope of information that regulators consider as commercially confidential in a marketing authorization application will be restricted by the guidance document. However, exceptions include the quality and manufacturing information of medicines, as well as information regarding facilities or equipment and some contractual arrangements between companies.

The guidance document also describes the protection of personal data as defined by the EU Directive 95/46/EC if it can lead to identify a person, and provides guidance on how personal data relating to experts, staff or patients can be identified and censored.

The guidance does not cover documents like pediatric investigation plans, orphan designations and veterinary medicines. The regulators will handle these documents according to their existing practices and legal provisions, together with applications that have either been withdrawn or rejected.

On the 9 March, 2012, the European network of medicines regulatory authorities have implemented two guidance documents, the ‘HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the Marketing Authorization (MA) Application – release of information after the granting of a Marketing Authorization’ and the ‘Principles to be applied for the implementation of the HMA/EMA Guidance on the identification of CCI and PPD in MA Applications’. Both documents should be interpreted as one unit.

These are consensus documents that provide the national and European authorities with practical orientations in dealing with requests of information releases of marketing authorization applications. The authorities are however bound by their respective legislations.

The guidelines will help authorities in the network to deal with the growing number of requests for accessing clinical and safety data in marketing authorization applications.

From the 1 June until the 1 September, 2011, the guidelines went on release for public consultation, receiving comments from twenty-four companies, associations and other organizations that welcomed the HMA/EMA guidelines and appreciated the effort of promoting a more transparent and consistent approach across the network.

The stakeholders main concerns were about releasing contractual arrangements between companies, personal data of experts and clinical and non-clinical data, whilst pharmaceutical companies were particularly concerned about the disclosure of non-clinical data. However they did commonly support the release of clinical data.

The final documents are planned for public presentation at next June’s meeting, which will be organized by HMA, EMA and the Danish EU Presidency in Copenhagen.

Written by Petra Rattue