The RMP Guidance applies to new drugs and biosimilar products for which marketing approval submission is made on or after April 1, 2013. Subsequently, details of the guidance have been presented by the notification entitled, “Formulation of the RMP” (Notification Nos. 0426-(2) of the Evaluation and Licensing Division and 0426-(1) of the Safety Division, PFSB both dated April 26, Pharmaceutical Regulations in Japan: 2014-3 - 37 - 2012), Formulation of the RMP Questions and Answers (Office communication dated September 7, 2012), Publication of the RMP (Notification No. 0304-(1) of the Evaluation and Licensing Division and 0304-(1) of the Safety Division, PFSB dated March 4, 2013), and Formulation of the RMP Questions and Answers (2) (Office communication datedMarch 6, 2013).
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