For the implementation of the regulation on the generic drug quality and efficacy evaluation of conformity of opinion (State Office (2016), 8th), options for further reference preparation process, this record is formulated and recommended procedures.
A, and this program by said parameter than preparations record and recommended work, is refers to drug production enterprise, and industry association, and original Institute drug production enterprise, and international recognized of same drug production enterprise, as applicants or recommended people, reference General oral solid preparations parameter than preparations select and determine Guide principles (food drug regulatory General announcement 2016 61st,), through record, and recommended, and declared, way, select parameter than preparations of process.
Second, the manufacturer may select reference preparations through the record. Production companies fill out the table reference preparation; writing the summary data (1) detailing the reference preparation select reasons for presenting varieties produced by the current effective approval documents, product approval and listing for the first time after the change description of history.
Three production enterprises, industry associations could be organized with the variety reference preparation recommendations. Industry associations complete the reference preparation recommended form for wrote of the summary information (1) detailing the reference preparation select reason; copies of submitted industry association qualification certificates, recommended records and descriptions, related with the production company agreed to recommend the certificate file.
Four, the original drug manufacturers, internationally recognized the same drug manufacturers whose products meet the reference preparation conditions, can take the initiative to declare as a reference preparation. Fill out the application form for the reference preparation production enterprises; writing the summary data (1), detailing the reference preparation select reason; provide declarations reference preparations in the past three years production and sales information.