Japan Edges out FDA for Fastest Approvals

Posted 31 July 2015 By Michael Mezher

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In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs).

New Drug Approvals in ICH Countries

A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014, examines NAS approvals in the US, EU and Japan.

The report finds that FDA reviews slowed slightly in 2014, to a median 343 days, while the European Medicines Agency (EMA) sped up from previous years, with a median 418 days from submission to approval.

While approval times at FDA and EMA have remained relatively stable for the past decade, Japan's approval times have dropped precipitously. In 2005 and 2006, Japan took around 800 days to approve NASs.

According to the report, 2014 saw the most NAS approvals of any year in the past decade at each of the three regulators, with 45 NAS approvals in the US, 52 in Japan and 30 in the EU. However, these numbers do not tell the whole tale.  Alhough FDA reviewed fewer NASs than PMDA in 2014, 78% of those NASs were being reviewed for the first time by an ICH country, compared to only 30% at PMDA. Additionally, 63% of the NASs PMDA reviewed had already been approved in the US or EU.

Expedited Reviews on the Rise in Japan

In 2014, half of the NASs approved in Japan benefited from priority reviews, far more than in previous years.

The US remained fairly consistent compared to previous years, with 58% of NASs given priority review. EMA also remained consistent in issuing accelerated assessments, which were granted to only 13% of its NAS approvals.

Record Year for Orphan Drugs

In 2014, all three agencies approved a record number of orphan drugs, with 33 orphan drugs approved in Japan, 24 in the US and 17 in the EU.

In both the US and Japan, orphan drugs were far more likely to benefit from an expedited review than non-orphan drugs. However, in the EU, orphan and non-orphan drugs were given expedited reviews at roughly the same rate, around 13-14%.

New Drug Approvals in ICH Countries 2005-2014

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Categories: Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration, News, US, Europe, Japan, FDA, EMA, MHLW, PMDA

Tags: New drug approvals, New active substance, NAS, Centre for Innovation in Regulatory Science, CIRS, ICH, Orphan drugs, Expedited review, Priority Review

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