A biological active substance derived by recombinant DNA technology would not automatically be granted the status of a new active substance (NAS) if a version of the active substance derived from a natural source was already present in an EU authorized medicinal product.
This is just one of points addressed in a draft reflection paper from the European Medicines Agency that describes the...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?