Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first

According to a recent analysis by the Center for Innovation in Regulatory Science (CIRS), Japanese regulators have the shortest time to approval for new drugs compared to their European, Australian, and US counterparts. The analysis also found that a majority of sponsors submit applications to the US Food and Drug Administration (FDA) before regulators in other markets.

The retrospective analysis looked at how long global regulators take to review and approve new active substances (NAS) in their respective jurisdictions between 2015 and 2024 from the European Medicines Agency (EMA), FDA, the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic, and the Australian Therapeutic Goods Administration (TGA).

CIRS found that PMDA had the shortest median approval time in 2014, with 290 days. FDA followed with 356 days, Health Canada with 363 days, TGA with 369 days, EMA with 430 days, and Swissmedic with 444 days.

"Despite improvements over the past 20 years, NAS median approval times still vary across the six authorities," said CIRS. "In 2024, the greatest difference in median approval times was 154 days between PMDA and Swissmedic.

“This difference was smaller when comparing the time from submission to the end of scientific assessment," the group added.

According to CIRS, FDA had the shortest median submission gap in 2014, with zero days, indicating that at least half of NAS submissions were submitted in the US first. The EMA had the second shortest median submission gap, with 49 days, followed by TGA with 219 days, Health Canada with 262 days, Swissmedic with 417 days, and PMDA with 727 days.

CIRS noted that FDA approved the highest number of NASs with 56 approvals, followed by PMDA with 53, Swissmedic with 37, EMA with 34, TGA with 33 and Health Canada with 24.

"While FDA consistently approved more NASs than its peers over the past decade, not all of these products are internationalized promptly, and some take considerable time to reach other markets," the group added.

FDA also topped the list of approvals for products that used the expedited review pathway in 2024, with 59% of products with expedited review getting approved. Interestingly, EMA did not approve any NASs under its accelerated assessment process, which, according to CIRS, was either because they were withdrawn or converted to standard review products.

"Median approval times were consistently shorter for expedited reviews compared to standard reviews across all six authorities in 2024, a pattern that has been sustained over the past five years," said CIRS. "Health Canada had the shortest median approval time for expedited reviews at 223 days, while TGA had the longest at 251 days.

Swissmedic also published an analysis comparing its drug approvals with those of EMA and FDA. In 2024, the agency said that EMA was 14% faster and FDA was 41% faster in authorizing products than itself. While the submission gap and the approval gap for NASs for Swissmedic and EMA narrowed year-on-year, the agency said the submission gap with FDA has widened compared to 2023, though the approval gap has narrowed.

"The EMA was 7% faster than Swissmedic for NA NAS (all procedures) and 16% faster for [additional indications (AI)] applications (all procedures)," said Swissmedic. "The FDA remained significantly faster than Swissmedic: throughput times were 45% shorter for NA NAS (all procedures) and 41% shorter for AIs (all procedures)."

CIRS report, Swissmedic report

Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first

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