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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.

EMA incentives

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 forIncentives offered by EMALink 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's 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
    (+2 years)
  • special funding available
EMA Orphan incentives
Paediatric medicines
  • 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
EMA PUMA
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
EMA PRIME

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