Comparative Research Between the New and Old Rules of Drug Supervision and Information Disclosure in the Drug Sampling and Testing Regulations

OBJECTIVE To explain the new rules for drug supervision and information disclosure in the drug sampling and testing regulation which was published in August 2019, and provide a reference for the relevant work. METHODS Compared the drug supervision and information disclosure rules between the regulations issued in August 2019 and July 2006 respectively, analyzed the need and value of the new rules and propose suggestions for implementation. RESULTS The drug sampling and testing regulation issued in August 2019 had added rules on tracing the sources of substandard drugs, research and disposal of risk, penalties of circulation, supervision and guidance of work and obligations and responsibilities of production and circulation units in terms of supervision, and rules on disclosure contents, major impact research and information management in terms of information disclosure. CONCLUSION These new rules facilitate the control and disposal of the counterfeit and inferior drugs and potential risk, and the disclosure of the sampling and testing results. They shall be paid enough attention and implemented in place by the drug supervision departments.