Updated on 15 May 2013
In terms of productivity in drug development, the Japanese pharma industry has expended much effort to improve the drug development process. Multi-regional clinical trials (MRCTs), being conducted in Asian countries, have increased in number, which has further resulted in a reduction in drug development duration and cost efficiencies since the number of Japanese patients in clinical trials has decreased.
The Pharmaceuticals & Medical Devices Agency (PMDA) has also reduced the time for review process of a new drug. Data shows that the ‘drug lag' in 2010 has decreased by 2.3 years on average from 2007 mainly due to a decrease in review time by PMDA, which is closing in on the US review timeline. Reducing the ‘drug lag' results in earlier patient accessibility to new drugs. The PMDA is also investigating the possibility of accepting clinical data in Asian countries with the evaluation of ethnic differences.
Another attractive point of the Japanese market is its speed-to-market access. In Japan, regulations state that 60 days after a new drug application (NDA) is approved by the regulatory authority, a new drug price is decided and listed and this is 100 percent reimbursable. Accordingly, Japan would be the fastest country in terms of the speed of patient access, which measures the aggregation of time from review to approval, and the time taken to determine drug price and get reimbursement. This enables pharma companies to quickly market a new drug for patients with sure predictability unlike in other Asian countries.
The Japanese regulatory agency has also made a concerted effort to improve time to approval by accepting MRCTs data, as well as by increasing the number of reviewers and adopting efficient review processes. With continued efforts to resolve complicated issues, the Japanese pharmaceutical market will provide greater value to patients, as well as stakeholders in medical related industries worldwide.