Author: Malte Glüsen, Senior Research Analyst
In the European regulatory landscape, the time between a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and the final decision by the European Commission (EC) is a critical phase. This period not only marks the final step before a product can be marketed across the EU but also plays a key role in aligning internal launch preparations, pricing strategies, and stakeholder communication.
To better understand this timeline, we conducted a structured analysis of publicly available data from the European Medicines Agency (EMA). In total we reviewed about 1,000 assessments, providing a robust basis for identifying patterns and trends. Specifically, we examined the duration between CHMP opinion and EC decision for all initial marketing authorisations and extensions of therapeutic indication submitted between 2019 and 2024. Only applications with a positive CHMP opinion were included, while accelerated assessments and COVID-19-related products were excluded to ensure comparability across years.
Our findings reveal a clear and consistent pattern: applications for extensions of therapeutic indication are processed more quickly than those for initial marketing authorisation. Over the six-year period, EC decisions for indication extensions were typically issued within 39 to 42 days following the CHMP opinion. In contrast, initial approvals required significantly more time, with a consistent timeline of approximately 58 to 62 days, about 20 days longer compared to extensions.
This difference has remained stable across all years analysed, suggesting a systematic feature of the regulatory process rather than isolated cases. The shorter timelines for indication extensions may reflect their narrower scope and the regulators’ existing familiarity with the underlying products.
Kintiga Findings
Kintiga Analysis
Applications for initial marketing authorisation and extensions of therapeutic indication
- Timeframe: 2019–2024
- Only positive CHMP opinions
- About 1,000 assessments
- Excluding accelerated assessments and COVID-19-related products
- Based on EMA annual reports
Across all six years, EC decisions for indication extensions were consistently issued faster than for initial approvals. On average, extensions were finalised within 39 to 42 days, while initial approvals took 58 to 62 days.
Strategic Implications
The time between CHMP opinion and EC decision is a predictable yet nuanced phase of the European regulatory process. While the overall duration has remained stable, the consistent advantage observed for indication extensions (averaging nearly three weeks faster than initial approvals) provides a valuable planning parameter.
For pharmaceutical and biotech companies, this insight is highly relevant. It allows for more accurate forecasting of approval dates, better coordination of launch activities, and more informed communication with internal and external stakeholders. Incorporating these timelines empowers regulatory, market access, and commercial teams to plan more effectively and align cross-functional efforts.
Leverage Data-driven Insights to Stay Ahead of the Curve
Understanding EMA approval timelines is critical—but acting on them is where the real value lies. Kintiga empowers regulatory and commercial teams to anticipate EC decisions with precision, streamline launch planning, and align cross-functional strategies.
Glossary of Abbreviations
CHMP – Committee for Medicinal Products for Human Use
A scientific committee within the European Medicines Agency responsible for preparing opinions on questions concerning medicines for human use.EC – European Commission
The executive branch of the European Union responsible for granting final marketing authorisations for medicinal products based on CHMP opinions.EMA – European Medicines Agency
A decentralised agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
