What question did this study set out to answer?

To investigate the global regulatory status of advanced therapy medicinal products (ATMPs) and compare their marketing authorizations across different agencies.

May 3, 2026

Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.

View Full Paper

Ask AI

Bookmark

Authors

ACAllan CramerFrederiksberg Hospital FSFreja Karuna Hemmingsen SørupUniversity of Copenhagen MLM A V LundUniversity of Copenhagen

Discussion

Member takes

Implication

Analysis investigates regulatory status of advanced therapy medicinal products in various countries, indicating significant disparities.

Key Points

To investigate the global regulatory status of advanced therapy medicinal products (ATMPs) and compare their marketing authorizations across different agencies.
Analyzed ATMPs granted marketing authorization as of January 1, 2025.
Included regulatory agencies from the USA, EU, Japan, UK, Canada, Australia, and Switzerland.
59 different ATMPs granted marketing authorization across included agencies.
42% of ATMPs were gene therapy products, while 44% were in haematology.
5 ATMPs received authorization from all agencies; 17 were approved by multiple agencies.

Cite This Study

Cramer et al. (2026) studied this question.

synapsesocial.com/papers/69f6e5ac8071d4f1bdfc648a https://doi.org/10.1002/bcp.70596

View Full Paper

Ask AI

Bookmark

May 3, 2026

Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.

View Full Paper

Ask AI

Bookmark

Authors

ACAllan CramerFrederiksberg Hospital FSFreja Karuna Hemmingsen SørupUniversity of Copenhagen MLM A V LundUniversity of Copenhagen

Discussion

Member takes

Implication

Analysis investigates regulatory status of advanced therapy medicinal products in various countries, indicating significant disparities.

Key Points

To investigate the global regulatory status of advanced therapy medicinal products (ATMPs) and compare their marketing authorizations across different agencies.
Analyzed ATMPs granted marketing authorization as of January 1, 2025.
Included regulatory agencies from the USA, EU, Japan, UK, Canada, Australia, and Switzerland.
59 different ATMPs granted marketing authorization across included agencies.
42% of ATMPs were gene therapy products, while 44% were in haematology.
5 ATMPs received authorization from all agencies; 17 were approved by multiple agencies.

Cite This Study

Cramer et al. (2026) studied this question.

synapsesocial.com/papers/69f6e5ac8071d4f1bdfc648a https://doi.org/10.1002/bcp.70596

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

View Full Paper

Ask AI

Bookmark