The European Medicines Agency (EMA) and National Competent Authorities (NCA) are working on a pilot project to offer scientific advice to not-for-profit organisations and academics (institutions and individuals) on repurposing an authorised medicine for a new indication.
The aim of this project is to gather or generate enough evidence to support a new indication with important public health benefits for a medicine whose marketing authorisation holder is otherwise unlikely to undertake the necessary research and regulatory steps.
The medicines that can undergo the repurposing need to have the appropriate eligibility criteria, such as to have a well-established active substance contained in a medicine with a valid marketing authorisation granted in a Member State or in the European Union, to be an authorised medicine (containing the concerned active substance) out of data exclusivity and market protection periods and out of basic patent/supplementary protection certificate (SPC) protection.
Scientific advice fees are waived automatically for eligible academic sponsors repurposing a medicine for an orphan condition. Fees will also be waived for a subset of other applicants based on the expected public health benefits and strength of the evidence in their application.
Sponsors wishing to seek EMA scientific advice should complete the submission form and submit it to EMA by February 28th.
Regulatory Pharma Net (RPN) has successfully supported companies in the optimization of the drug development strategies including assistance in the Scientific Advice procedure. RPN is ready to provide support and prompt updates about any new initiative launched by the authorities.
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