EMA

Reflection paper on classification of advanced therapies released for public consultation

The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation. The paper clarifies the legal basis for the classification of medicines as advanced therapies and provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines. It also gives details on the types of information that applicants need to submit to the Agency when applying for classification of their medicine as an advanced therapy, and discusses of some borderline cases and areas where scientific knowledge is limited or evolving rapidly.

eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency

Following a successful pilot, the European Medicines Agency's eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines. This is an important milestone in the Agency's long-term strategy for the electronic submission of applications, which aims to improve efficiency and decrease costs for applicants. The eSubmission Gateway is an electronic submission channel that allows applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the Electronic Common Technical Document (eCTD) format.

Towards a robust global framework for conduct and oversight of clinical trials

European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU. The European Medicines Agency today published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.

European regulators propose way forward for publication of full clinical trial data

A group of European regulators have set out a way forward for the publication of the results of clinical trials of authorised medicines. 'Open clinical trial data for all? A view from regulators', published in the journal PLoS Medicine, responds to an article in the same issue by Doshi and colleagues, which calls for open access to all clinical-trial data so that independent re-analysis of medicines' benefits and risks can be conducted.

The European Medicines Agency supports World Health Day

World Health Day is a global campaign held every year on 7 April to mark the anniversary of the founding of the World Health Organization (WHO). Each year's theme highlights a priority area of concern for WHO. In 2012, the theme for the day is ageing and health, focusing on how good health throughout life can help older people lead full and productive lives and be a resource for their families and communities.

European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data

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.

EU Clinical Trials Register information now available through WHO’s International Clinical Trials Registry Platform

Information contained in the European Union (EU) Clinical Trials Register managed by the European Medicines Agency is available through the WHO International Clinical Trial Registry Platform (ICTRP). This follows recognition by the World Health Organization (WHO) in September 2011 of the EU Clinical Trials Register as one of the 'primary registries' for the ICTRP. The WHO and the Agency have worked together in developing the technical processes to allow data transfer from the EU Clinical Trials Register to ICTRP.

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