Regulatory Dynamics
-
Technical Guidelines for Clinical Comparability Research of Preventive Vaccines
In order to further standardize and improve the clinical research and development of vaccines, and strengthen the supervision of vaccine quality and safety, NMPA made the Technical Guidelines for Clinical Comparability Research of Preventive Vaccines.2020-01-03 -
Technical Guidelines for Clinical Trials of Drugs in the Treatment of Nonalcoholic Steatohepatitis
The guidelines are jointly discussed and formulated by the drug regulatory department and clinical researchers to provide technical suggestions for the research and development of drugs in the treatment of nonalcoholic steatohepatitis (NASH).2019-12-23 -
新版《药品管理法》修订概况
新修订《药品管理法》全面贯彻落实党中央有关药品安全“四个最严”要求,明确了保护和促进公众健康的药品管理工作使命,确立了以人民健康为中心,坚持风险管理、全程管控、社会共治的基本原则,要求建立科学、严格的监督管理制度,全面提升药品质量,保障药品的安全、有效、可及2019-09-12 -
重磅!今日新《药品管理法》表决通过,于2019年12月1日起施行
十三届全国人大常委会第十二次会议26日表决通过修订后的药品管理法。修订后的药品管理法共十二章155条,加大了对药品违法行为的处罚力度。其中明确规定:批准上市药品的审评结论和依据应当依法公开并接受社会监督。影响新药研发的核心部分药物临床试验机构备案制获新法规确认。2019-08-26 -
Regulations of the People's Republic of China on the Administration of Human Genetic Resources
Regulations of the People's Republic of China on the Administration of Human Genetic Resources was adopted at the 41st executive meeting of the State Council on Mar 20th, 2019. It is hereby promulgated and shall be implemented by Jul 1st,2020.2019-08-26 -
Announcement on Inclusion of Oxycodone Containing Compound Preparations and Other Varieties in the Administration of Psychotropic Drugs by NMPA
In accordance with the relevant provisions of the Regulations on the Administration of Narcotic drugs and Psychotropic Substances, NMPA, the Ministry of Public Security and the National Health Commission decided to list the compound preparations containing oxycodone in the administration of psychotropic substances.2019-08-16