EMA publishes its work programme for 2014: potential for rare diseases
The European Medicines Agency has published its annual work programme for 2014 which shows great potential for developers of orphan medicinal products and the rare disease community.
The Agency has identified key objectives in the area of evaluating activities for human medicines 2014, all of which should help in bringing more orphan medicinal products into the market. The Agency will aim to increase the success rate for marketing-authorisation applications through a more active use of scientific advice and other pre-application support to encourage the development of new medicines, especially in areas of unmet need, such as orphan medicinal products. The Agency will also work towards facilitating the use and development of emerging technologies and approaches in developing new medicinal products in addition to improving international cooperation in pre-authorisation support, especially in the area of scientific-advice. This was also reflected in their recent workshop on worldwide orphan medicinal designation
Broadly, the Agency aims to offer support for innovative methodologies, such as biomarker qualification, as well as for the development of new approaches and medicines, such as stem-cell technology. In addition to providing advice to sponsors applying for orphan medicines, paediatric medicines, advanced therapies, the Agency also envisions providing greater support to the HTA throughout the “lifecycle of the medicinal product”. The Agency will also work towards further facilitating the early stages of medicines development, implementing the clinical trials legislation, enhance cooperation within the European medicines network and with other European and international partners with increased transparency as one of their key focus. These goals and objectives outlined in EMA work programme for 2014 will prove to be greatly beneficial in faster access of OMP’s to patients.
Read the EMA Work Programme 2014