With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.
【Pharmaceutical Affairs Committee of the Japan Pharmaceutical Manufacturers Association】
Discontinues Development, Unable to Acquire Designation as Orphan Drugs – Demand for Designation Criteria Equivalent to Europe and U.S.
December 09th, 2020
In the questionnaire investigation conducted on 59 member companies by the pharmaceutical affairs committee of the Japan Pharmaceutical Manufacturers Association, it became apparent that in Japan there have been cases where development was discontinued, such as abandonment of efficacy addition, because of failure to acquire designation as orphan drugs. In Japan, there have been many cases where the drugs were not designated because the data showing efficaciousness and safety significantly higher than those of existing drugs did not exist at the time of consulting. On the other hand, in Europe and U.S., they found that there was a tendency to give designations widely at an early stage based on the data from Phase I trial and Phase II trial. The committee is demanding the regulatory authority to make the designation criteria to be equivalent to that of Europe and U.S.
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