Seoul aims to enhance trust in generics, build integrated information network 

The Ministry of Food and Drug Safety will make the Korean version of “Orange Book,” allowing people to search information about generic drugs, such as permission-related details and the results of bioequivalence testing, officials said.

The Orange Book refers to the list of medicines, original or generic, including their bioequivalence assessments, approved by the U.S. Food and Drug Admiration. It also provides information on patent trials and related lawsuits. FDA first released the book as a print publication in 1980, and its nickname comes from the color of its cover.

Web search has been available since 1997, and checking through smartphone application also became possible a few years ago. Japan is operating JP Orange Book, separating generic drugs to provide more detailed data on bioequivalence testing designs, equivalence assessment results and other matters, the officials said.

The ministry set up the plan to make Korean Orange Book last year and will collect information in earnest this year. It will activate a consultative group of related organizations, including Korea Pharmaceutical Manufacturers Association and Korea Research-based Pharma Industry Association, to discuss what contents they should include in the book.

The principal purpose of this book is to improve trust in Korean generic drugs. The ministry will include the Orange Book in an integrated information control network it is now establishing for completion as early as next year.

Though it is still at a discussion stage, the Korean Orange Book will likely take the intermediate form between its U.S. and Japanese counterparts.

According to a ministry source, the Korean version will allow people to search information on reference-listed drugs and that on generic drugs, such as biokinetics, pharmacology, and results of bioequivalence testing, at the same time.

Given the vast amount of information on bioequivalence tests, however, it plans to discuss with the private sector before deciding the extent to which the search of information is available, the source said.

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