The Pharmaceuticals and Medical Devices Agency (PMDA) has created a website to centralize documents on why and how companies should develop products for the Japanese market.
 
PMDA has recently embarked on a push to engage with overseas companies, providing the help and resources they need to bring their products to market in Japan. The initiative includes the creation of the regulatory agency’s first office in the US and now the launch of a website that covers what drug and device companies need to do to access the Japanese market.
 
The opening section of the English-language website outlines why Japan is an attractive market for drug developers, explains PMDA’s support for venture companies, and details the country’s medical device approval process. Across the files, PMDA presents Japan as a large market with predictable, internationally harmonized processes that can act as a gateway to the rest of Asia.
 
The website also provides links to additional information on PMDA and drug and device regulation in Japan. One section outlines PMDA regulations and services, covering topics such as drug and medical device reviews, good practice inspections, and postmarketing safety measures. Other sections link to lists of products approved in Japan, information on the accreditation of foreign manufacturers, and the websites of public organizations and industry associations.
 
Finally, the site provides information on PMDA’s “advanced efforts,” a set of initiatives such as its “early consideration” scheme, and work to coordinate its offices to examine issues that cut across institutional boundaries.  The early consideration scheme, which provides information on specific topics such as developing pulmonary arterial hypertension drugs, has ramped up recently. PMDA has published five English-language documents since December, for a total of seven...[Japan harmaceuticals and Medical Devices Agency]