The Heads of Medicines Agencies (HMA) and the European Medicines Agency
(EMA) have adopted a joint guidance document, providing for the first time for
a consistent Europe-wide approach to the identification of commercially confidential
information and personal data in a marketing authorisation application.
This is a major step for transparency. In future, regulatory authorities in
the European Economic Area (EEA) will apply the same principles to identify
which parts of an application dossier can or cannot be released in response to
access to documents requests. This is regardless of whether the medicine
concerned has been authorised using the centralised, mutual recognition or
decentralised procedures.
The guidance document limits the scope of what information regulators will
consider to be commercially confidential in a marketing authorisation
application. The exceptions mainly relate to information about quality and
manufacturing of a medicine, as well as information about facilities or
equipment and some contractual arrangements between companies.
In addition, the guidance document sets out how personal data as defined by
the EU Directive 95/46/EC will be protected if it can lead to the
identification of a person. The document gives further guidance on how to
identify personal data relating to experts, staff or patients that should be
redacted.
Dossiers such as orphan designations, paediatric investigation plans and
veterinary medicines are not covered by the guidance. Together with those
applications that have been withdrawn or rejected, these will be handled by
regulators according to their existing practices and legal provisions.
The European network of medicines regulatory authorities adopted two
guidance documents on 9 March 2012, which should be interpreted jointly. They are:
- HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the Marketing Authorisation (MA) Application - release of information after the granting of a Marketing Authorisation
- Principles to be applied for the implementation of the HMA/EMA Guidance on the identification of CCI and PPD in MA Applications
These are consensus documents which give practical orientations for
national and European authorities in dealing with requests for release of
information regarding marketing authorisation applications; however, the
authorities remain bound by their respective legislations.
This initiative will help the authorities in the network to cope with a
growing number of requests for access to clinical and safety data contained in
a marketing authorisation application.
The guidance documents were released for public consultation from 1 June to
1 September 2011. Twenty-four companies, associations and other
organisations sent comments, welcoming the HMA/EMA initiative and the efforts
to promote a more transparent and consistent approach across the network.
The main concerns raised by stakeholders were related to the release of
contractual arrangements between companies, personal data of experts and
clinical and non-clinical data. Pharmaceutical companies raised specific
concerns with regard to the disclosure of non-clinical data, while the release
of clinical data was generally supported.
The authorities plan to publicly present the final documents to
stakeholders at a meeting to be organised next June by HMA, EMA and the Danish
EU Presidency in Copenhagen.
For further information please contact: hma.ps@imb.ie or press@ema.europa.eu