Abstract: At present, the level of drug regulation fee in China is too low to provide cost compensation for drug regulation activities and improve the regulation efficiency through regulation fee. For private articles, public goods and quasi-public articles, it is applicable to provide regulations through price, tax and fee regimes, and administrative regulation is provided for quasi-public articles to a great extent. The design of regulation fee shall be based on the fair, efficient and legal principle. It is feasible to introduce drug regulation fee regime in China from perspectives of the nature of drug regulation activities, the position of drug regulation mechanisms, and the purpose of benefiting the beneficiaries, improving drug examination and approval performance and realizing drug regulation objectives. Therefore, it shall legally set drug regulation fee, confirm the range and standard of drug regulation fee, perfect the forms and adjustment procedures of drug regulation fee, define the use of regulation fee, revise the legal rules and impel the development and reform of drug regulation fee regime in China.
Keywords: Drug Regulation; Regulation Fee; Administrative Fee; Administrative Law