For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
REGULATORY
Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
The Ministry of Health, Labor and Welfare (MHLW) has introduced a new category of post-approval procedures for “moderate-risk” manufacturing changes for ethical drugs, which would shorten the review period from the current median six months to 40 days. The new…
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