Further support: EMA and incentives
EU Innovation Network (EU-IN)
The Innovation Office is also part of the EU Innovation Network (EU-IN), which provides a platform for the cooperation of Innovation Offices in national regulatory agencies and the EMA's Innovation Task Force (ITF). As the pace of innovation is very rapid and the medicinal products developed tend to be more complex the network aims at providing the appropriate infrastructure and collaboration to foster and encourage innovative development in the EU.
European Scientific Advice
In addition to providing national scientific advice, the Paul-Ehrlich-Institut is also actively involved in European scientific advice and protocol assistance (Scientific advice for orphan medicinal products).
Experts from the Paul-Ehrlich-Institut are represented in the CHMP (Committee for Medicinal Product for Human Use), the CAT (Committee for Advanced Therapies) and the SAWP (Scientific Advice Working Party). The SAWP is in charge of all European advice.
Applications for scientific advice / protocol assistance should be submitted to the EMA. The fees for this procedure are charged by the EMA.
The European Medicines Agency (EMA) offers a range of incentives to encourage the development of medicines. The following table summarises the incentives offered.
Selection of incentives offered by European Medicines Agency (EMA)
|Incentives for||Incentives offered by EMA||Link to EMA|
|Small and medium sized enterprises (SME)|
|Medicines with orphan designation||EMA Orphan incentives|
|Paediatric medicines||EMA Paediatric medicines|
|Paediatric-use marketing authorisation (PUMA)||EMA PUMA|
|Priority Medicines (PRIME)||EMA PRIME|