Since 2018 the Innovation Office organises and coordinates the national advice meetings for all products in responsibility of the PEI. The Innovation Office is the central contact point for your questions regarding planning and conduct of national advice at PEI. In addition it provides you with information for medicinal product development and it is involved in national and international projects aiming to improve the advice offered in order to efficiently support the developmental process.
The Innovation Office was established in 2009 with focus on advanced therapy medicinal products (ATMP) to support their developmental process from drug discovery to marketing authorisation in Germany as early as possible.
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.
|Incentives for||Incentives offered by EMA||Link to EMA|
|Small and medium sized enterprises (SME)|
- regulatory, financial and administrative assistance
- fee exemptions and reductions for regulatory procedures (for detailed information see EMA Website)
EMA SME criteria
EMA SME User Guide
EMA SME incentives
|Medicines with orphan designation|
- reduced fees for protocol assistance, marketing-authorisation
application, inspections before authorisation, etc.
- access to centralised marketing authorisation
- ten years of market exclusivity
- special funding available
|EMA Orphan Incentives|
- additional 2 years of market exclusivity
- scientific advice and protocol assistance are free of charge
|EMA paediatric medicines |
|Paediatric-use marketing authorisation (PUMA)|
- 10 years of market protection
|Priority Medicines (PRIME)|
- early and proactive support by CHMP/CAT rapporteur
- kick-off meeting with CHMP/CAT rapporteur + experts
- scientific advice at key milestones
- accelerated assessment of medicines applications
Overview of the development of the advice meetings at the Innovation Office
The graph is updated on a regular basis.
* only ATMP-specific advice meetings
o since middle of 2018 central coordination of all advice meetings at PEI