A firm stride for regulatory by Japan’s PMDA

 In Japan, the Pharmaceutical and Medical Device Agency (PMDA) is responsible from the beginning of preliminary non-clinical phases through the late phases including the pivotal clinical trials.  interestingly, increasing fiscal burden and ageing society and decreasing population posing the challenges as well as emergence of unseen opportunities in Japanese pharmaceutical market. Japanese pharma economy is witnessing the transition where PMDA as well has approved 22 NAS (New Active Substance) in record 333 days (Median approval time), second fastest approval days after FDA of 243 days (Median approval time) in 2017.

In late 2017, Japan PMDA introduced a new conditional early approval system for the clinical trials for life threatening diseases and rare diseases. Conditional early approval system is a system where the approval is granted after the completion of phase I/II stage skipping the phase III studies.

This is applicable only for the following conditions. 1. Life threatening conditions with very limited treatment options 2. Conditions where it is difficult to conduct clinical trials or conditions which are very rare leading to a limited patient population.

Compared to standard review, Conditional Early Approval significantly speeds up the approval process, bringing life-saving treatments to patients faster. Safety and efficacy are further monitored in the much longer post-market phase However, the approval is conditional, and reconfirmation of post marketing efficacy and safety is compulsory and failure in post marketing surveillance may lead to the withdrawal of the said conditional approval.

The approval timelines in Japan by their regulatory authorities is only 30 days (if there are no objections by the authorities). And Ethics committee approval is received between 4-8 weeks’ time. The submissions can be parallel or sequential.

PMDA also launched a new project called MID-NET Project (medical information database network) for real time assessment of drug safety. It’s a system to analyse electronic health record, insurance claim data, diagnostic procedure combination data etc. and it was established to increase the predictability and transparency in post marketing change control.