EU EMA and National agency dialogue and associated procedures

There are many opportunities during drug development for dialogue with various competent authorities. Some are mandatory, others simply recommended. Following agency input or advice increases the likelihood of successful submissions at a future date and while it is not binding on agencies or indeed the development company, deviations from input or advice received must be justified scientifically.

Below is a sample of some of the dialogue and procedure we can help with:

  • Small and Medium-sized Enterprise (SME) status with EMA for those companies who meet the criteria, this is recommended to avail of fee reduction incentives
  • Advanced Therapy Medicinal Product (ATMP) classification and certification for immediate access to EMA support
  • Supporting interactions with the EMA Innovative Task Force and other aligned National procedures
  • Orphan Designation for those drugs with indications for rare diseases
  • Protocol or Scientific Advice to discuss issues with Quality and/or Safety and/or Clinical/ non-Clinical questions
  • Health Technology Assessments (HTA) Advice to discuss issues Payers may have with the development plan
  • Paediatric Investigation Plans (PIP) – Mandatory submission after Phase 1 and must be in place before Marketing Authorisation Application (MAA) for adult indication to be validated
  • Priority Medicines (PRIME) designation – early free interaction through development and eligibility to fast track EMA procedure for MAA and other aligned National procedures

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