The first full overhaul of EU pharma law since 2004.
Adopted by the Council of the EU on September 28, 2026, it is expected to enter into force by the end of 2026 and to apply in stages until 2028. Your filing and launch plans depend on it now.
This White Paper uncovers:
Why standard EU protection drops to 9 years, and how to earn up to 2 more.
How your filing date, before or after Q4 2028, sets your protection regime.
How orphan exclusivity becomes 4, 9 or 11 years.
What changes for pediatric waivers, deferrals and launch timelines.
A 226-day standard procedure, with PRIME and phased review in the new law.
