The aim is to provide:
- a better understanding of the process between an idea and an approved medicinal product
- access to experienced regulatory expertise and assessors
- an opportunity to discuss scientific and regulatory issues prior to application to ensure that the documentation is in compliance with regulatory requirements
- advice on how to design and perform studies to get interpretable results the first time
What does NoMA offer
NoMA offers regulatory and scientific advice through all phases of the life cycle of a medicinal product. Our general regulatory and scientific expertise is built upon active participation of our scientific staff in the assessments of various applications in both national and European procedures. Due to the EEA agreement Norway has the same rights and obligations concerning medicinal products as member states of the European Union. NoMA contributes both to the assessments and to the development of new guidelines through participation in various working parties and scientific committees. We collaborate with the other Nordic countries regarding assessments and provision of scientific advice.
Schematic presentation of the development of a medicinal product
MA = market authorisation
NoMA’s special areas of expertise
NoMA has developed the following special areas of expertise within the European network:
- Human medicines:
- Prophylactic vaccines
- Solid tumors
- Veterinary medicines:
- Fish (vaccines and chemical/synthetic active substances)
EMA also provides scientific advice
The European Medicines Agency (EMA) offers scientific advice to companies involved in developing medicinal products. It is worth noting that EMA does not offer scientific advice to the academia. National scientific advice is, however, a faster and more readily available supplement to EMA’s procedure and an offer to academic research groups.
EMA has also established an office for small and medium-sized enterprises (SME office). Companies can apply to EMA for a SME status, which provides numerous advantages. One important advantage is significantly reduced fees for EMA’s scientific advice.
See more information about what EMA offers.