No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy, somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field. Pharmacovigilance risk assessment A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU). Other activities The Agency carries out a number of activities, including: Pharmacovigilance: The Agency constantly monitors the safety of medicines through a pharmacovigilance network and EudraVigilance, so that it can take appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised. Referrals: The Agency coordinates arbitration procedures relating to medicinal products that are approved or under consideration by Member States in non-centralized authorisation procedures. Scientific Advice: Companies wishing to receive scientific advice from the CHMP or CVMP on the appropriate tests and studies to carry out in the development of a medicinal products can request it prior to or during the development program. Telematics projects: The Agency is responsible for implementing a central set of pan-European systems and databases such as EudraVigilance, EudraCT and EudraPharm. Centralised marketing authorisations The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission a centralised (or "community") marketing authorisation (MA) valid in all European Union member states and in Iceland, Liechtenstein and Norway. The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. It is also compulsory for advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and for orphan medicines (for rare diseases). The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA. For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA. History 1995-2004: Inception The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as