Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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