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Orphan Drug Designation (ODD)
EU INCENTIVES
Receiving Orphan Drug Designation (ODD) is a key milestone for products seeking approval for the treatment of rare diseases.
In the European Union, it grants access to Orphan Medicinal Products (OMP) Regulation incentives such as:
- A 10-year market exclusivity period.
- Scientific Advice (Protocol Assistance) from the European Medicines Agency (EMA) at a reduced charge, to validate the development strategy and secure a smoother registration process.
- Significantly reduced fees for regulatory activities, including Marketing Authorization Applications (MAAs).
- EU-funds in support of OMP clinical trials.
- Incentives in EU Member States.
TAILORED REGULATORY ASSISTANCE
RPN provides tailored regulatory assistance for Orphan Drugs and guides companies in targeting the regulatory milestones to build product value for the EU market, also to facilitate external funding, including:
- Feasibility analysis of the request for Orphan Designation Application in the EU.
- Advice on the EMA ODD procedure and definition of the submission strategy for the relevant product and indication.
- Pre-submission meeting (if applicable).
- Regulatory and scientific writing support in the preparation of the EMA ODD application according to the relevant EU guidelines.
- Support throughout the procedure, from submission to the Committee for Orphan Medicinal Products (COMP) opinion.