Comparative study of promoted generic substitution policies in China, USA and Japan based on full cycle management

Corresponding author: SHAO Rong, shaorong118@163.com

DOI: 10.12201/bmr.202305.00004

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  Abstract: Objective:Based on the concept of full cycle management, multiple links from the registration of generic drug R D, market access, clinical use, and postmarketing reevaluation will provide recommendations for the development and improvement of the policy on the promotion of generic drug substitution in China. Methods: Using a policy research approach and a literature research approach, we conducted a comparative analysis of the current state of policy on the promotion of generic drug substitution between China and Japan. Conclusions: Generic drug substitution is a systematic engineering involving multiple links, and the United States and Japan have addressed this topic by continually refining technical standards and data guidelines in the R D registration link, reasonably pricing and Medicare incentives in the market access link, managing physician pharmacist prescribing behavior in the clinical use link, enhancing advocacy Education, and reevaluating and evaluating alternative effects of generic drugs in the postmarketing reevaluation link, A full cycle policy system of generic drug substitution promotion was constructed and the objectives of generic drug substitution were achieved.

  Key words: Generic substitution; Medicare payment; Consistency evaluation of generic drugs

  Submit time: 9 May 2023

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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