Twenty-four regulations, such as the Code of Quality Management for Drug Clinical Trials, have been repealed.

On July 16, 2020, the official website of the State Administration of Market Supervision and Administration issued the Decision of the State Administration of Market Supervision and Administration on the Repeal of Some Regulations (No. 29), which is a clean-up of existing departmental regulations by the State Administration of Market Supervision and Administration in order to further deepen institutional reform, optimize the business environment and enhance regulatory effectiveness.
after cleaning up, the 2003 edition of the "Drug Clinical TrialS Quality Management Code" and other 24 regulations to be repealed, this decision from July 16, 2020 announced the date of the implementation of some regulations affecting pharmaceutical companies, such as 24 "Drug Clinical TrialS Quality Management Code" needs to focus on.
. Why the 2003 edition of the Drug Clinical Trial Quality Management Code 2003 "Drug Clinical Trial Quality Management Code" (State Food and Drug Administration Order No. 3) has been implemented for 17 years since its promulgation and implementation in 2003, with the rapid development of drug research and development and the deepening of the reform of the drug review and approval system, drug clinical trials and the management of drug management problems are increasingly prominent, mainly reflected in the bid, researchers, ethics committee and other drug clinical trials involved in the implementation of the responsibilities.
's inaccurate understanding of the 2003 edition of the Code of Quality Management of Drug Clinical Trials is inaccurate, and the lack of safety and security for subjects directly affects the reliability of drug clinical trial data, the differences between the 2003 edition of the Code of Quality Management of Drug Clinical Trials and the relevant guidelines of ICH, as well as the emergence of new concepts in the field of drug clinical trials at home and abroad and the application of new technologies, the urgent need to make corresponding changes and additions to the original content, adapt to the needs of drug regulatory work.
on April 26, 2020, the State Drug Administration and the National Health And Ingestion jointly issued a new version of the Code of Quality Management of Drug Clinical Trials (No. 57 of 2020), article 83, which stipulates that the Code will come into effect on July 1, 2020, but there is no clear old version (August 6, 2003 issued " Drug Clinical Trial Quality Management Code) to repeal the provisions.
On July 16, 2020, the State Administration of Market Supervision and Administration issued the Decision of the State Administration of Market Supervision and Administration on the Repeal of Some Regulations (No. 29) to announce the date of repeal of the 2003 edition of the Code of Quality Management for Drug Clinical Trials.
References gkml.samr.gov.cn/nsjg/fgs/202007/t20200716_319829.html.