[Trends in the quality evaluation of generic products and bioequivalence guidelines].

Recent activities on the generic products such as the revision of bioequivalence guidelines, the accomplish of the reevaluation of the oral dosage forms approved before 1995, and the action program for promoting comfortable use of generics issued by MHLW in 2007, were summarized in this review. The bioequivalence guidelines established in 1997 were revised in 2012 based on the discussion in a dissolution working group (WG). The WG were consists of the members from pharmaceutical companies, academia and regulators belonging to MHLW, PMDA and NIHS. In the revision, some flexibility in the dissolution test conditions was achieved considering the many experiences. And also the special Q&A for the combination products was published at the same time. The reevaluation of the oral products since 1997 was completed in 2010, and 1361 dissolution specifications for 4133 oral products were noticed. Through the reevaluation the sufficient similarity in the dissolution profiles between the standards product and the generic products was achieved in the Japanese pharmaceutical market. In the action program to promote the share of generics, the special committee was established in the NIHS to assess the scientific papers that reported the quality concern of the commercial generic products and to confirm the target quality of the products by testing. Many generic products were checked their dissolution profile similarities to the reference products in multimedia dissolution tests and the appropriate similarities were shown in most products. In some preparations, the purity tests were performed and the content of the impurity is confirmed to be in the acceptance range.