From today, the implementation of 4 regulations affects all pharmaceutical workers

From March 1st, the supplementary provisions of the new criminal law, the 2020 drug catalogue, the management methods for the batch issuance of biological products, and the management methods for the clinical application of anti-tumor drugs have been implemented, affecting all pharmaceutical workers.

Supplementary provisions of the Criminal Law are issued, 10 crimes involving drugmakers

On February 27, the official website of the Supreme People's Court issued the "Supplementary Provisions of the Supreme People's Court and the Supreme People's Procuratorate on the Implementation of the Criminal Law of the People's Republic of China on Determining Crimes (7)", which will be implemented on March 1.

Five articles directly related to the life cycle of drugs: crimes of producing, selling, and providing counterfeit drugs; crimes of producing, selling, and providing substandard drugs; crimes of obstructing drug management; crimes of obstructing stimulant management; crimes of dereliction of duty in food and drug supervision;

Five items that may be related to the entire life cycle of drugs: the crime of illegally collecting human genetic resources and smuggling of personal genetic resource materials; the crime of illegal implantation of gene editing and embryo cloning; the crime of harming precious and endangered wild animals; illegal hunting, acquisition, transportation, Crime of selling terrestrial wild animals; crime of endangering national key protected plants.

The 2020 drug catalog will be implemented, and 2,800 drugs will be included

From March 1, 2021, the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)" will be officially implemented.

Measures for the Administration of Batch Issuance of Biological Products: More detailed management of vaccines and drugs

On December 21, 2020, the State Administration for Market Regulation announced the "Administrative Measures for the Batch Issuance of Biological Products" that will come into force on March 1, 2021.

During the revision process of the Measures, the principles and systems established by the Vaccine Administration Law of the People’s Republic of China and the Drug Administration Law of the People’s Republic of China were refined, and the advanced experience of foreign countries related to batch issuance management was used for reference to further improve the identification and approval of batches of biological products.

Management Measures for the Clinical Application of Anti-tumor Drugs: Whole Process Management

On December 28, the National Health Commission issued the "Notice on Issuing the Administrative Measures for the Clinical Application of Anti-tumor Drugs (Trial)".

The "Measures" has five chapters and 48 articles, which manage the entire process of the selection, procurement, storage, prescription, deployment, clinical application and drug evaluation of anti-tumor drugs in medical institutions.