The Ministry of Health Labour and Welfare (MHLW) outlined its Sakigake – or 'pioneer' - strategy last July. The aim is to foster pharmaceutical industry innovation, help local companies grow in the global market and accelerate drug and device approvals.
Akagawa told delegates at CPhI Japan in Tokyo last week the strategy involved strengthening safety precautions for medicines, developing a medical device regulatory system and creating a regenerative medicines framework, citing the latter measure as a particular highlight.
“I would like to emphasise that the third point… is epoch making” he said, explaining that the regenerative medicine framework takes a different approach to data review than laws covering traditional small molecule drugs.
“Regular drugs and medical devices it take some time to develop because they are reviewed after detailed data on safety and efficacy is collected. On the other hand, for regenerative medicines the new laws make it possible to apply for conditional approval at the early stage when efficacy can be estimated.
“Conditional approval is granted for up to seven years. Regular approval is granted after reviewing data collect in the market” Akagawa continued, adding that “as a result it is expected that the innovative regenerative medicines will be able to be delivered to patients at an early stage.”
Sakigake is also designed to encourage innovation more generally according to Akagawa, who said the aim is to enable “the practical use of innovative medicines and medical devices as early as possible to help patients in Japan and around the world.”
Measures include granting drugs with “epoch-making therapeutic efficacy” for priority review – potentially cutting approval time from 12 to six months – provided they demonstrate excellent efficacy and safety.
Akagawa added that such “products are expected to be approved in Japan earlier than elsewhere” explaining that this is possible because sponsor firms are required to “consult with the PMDA at the earliest stage of development.”