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THE PULSE OF GLOBAL PHARMA REGULATION
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EUROPE · EMA INTELLIGENCE
EU edition · 2026-04
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REGULATORY · EMA
Shortened EMA Assessment Timeline
The standard review timeline for EMA assessments has been reduced from 210 to 180 days, while the accelerated pathway is now 150 days.
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REGULATORY · EMA
Simplified EMA Committee Structure
The EMA has streamlined its committee structure, reducing the number of committees from five to two main scientific committees for human medicines.
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REGULATORY · EMA
Unlimited Marketing Authorizations
Marketing authorizations under the centralized procedure will now be valid indefinitely by default, eliminating the previous renewal cycle.
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ARTICLE
Overview of the New EU Pharmaceutical Reforms
The EU has published comprehensive pharmaceutical reform texts on 6 March 2026, marking a significant update to the regulatory framework. This new legislation, set to take effect in 2026, will replace the...
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Official sources
- https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation
- https://www.ema.europa.eu/en/documents/report/final-programming-document-2026-28_en.pdf
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EU
· Edition 2026-04
· B2B pharma intelligence, generated and reviewed by editors.
© NovaPharmaNews. Trusted pharmaceutical intelligence covering FDA, EMA, NMPA, and PMDA regulatory developments across global markets.
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