TOKYO – Japanese authorities are stepping up their push to become more transparent by working with foreign companies in the health care product market.
A series of new policies should continue evening the playing field for foreign and domestic companies, while an electoral victory over the weekend by the incumbent government should ensure the continuity of that push for transparency.
Japan’s Ministry of Health, Labour and Welfare recently issued a set of English-language guidelines on handling the authorization for combination products. The goal of the guidelines is to act as a convenient reference to overseas companies seeking approval of their products in Japan.
“The handling of products that combine drugs and medical devices has been indicated in previous notifications,” said Tomoko Okudaira, spokeswoman for the Pharmaceuticals and Medial Devices Agency (PMDA).
The Pharmaceuticals and Medical Devices Agency Act was enacted