Discussion Related to Approval Document Based on the Results of a Questionnaire Survey on the “Actual Situation of Regulatory Actions Required of Established Conditions and Those Changes”

Abstract

The Japan Pharmaceutical Manufacturers Association’s (JPMA) Regulatory Affairs Committee recently conducted a survey about differences in regulatory submissions in Japan, US and EU. Key topics addressed in the survey are as follows: ・The amount of Established Conditions considered necessary to assure product quality; ・The category of regulatory submissions in US and EU, in which past cases of regulatory submissions required in Japan; ・When US or EU submissions were required prior to approval, the time required for submission, and whether GMP inspections were conducted during the submissions.