The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
REGULATORY
JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
A senior official of the Japan Pharmaceutical Manufacturers Association (JPMA) has reiterated the trade group’s push for the use of data from what is called “specified clinical research (tokutei rinsho kenkyu)” in early-stage trials and the conditional early approval system…
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