"Draft for Comments", new chapters for drug marketing authorization holders, etc.

On May 9, the State Drug Administration publicly solicited opinions from the public on the newly revised "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China (Draft for Comments.

It is reported that the current "Implementation Regulations of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as "Implementation Regulations") was officially promulgated and implemented in 200 In order to implement the newly formulated and revised Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, further strengthen drug supervision and management, ensure the safety of people's medication, and promote the high-quality development of the drug industry, the State Food and Drug Administration organized a review of the "China Drug Administratio.

The "Draft for Comments" has ten chapters and 181 articl.

The "Draft for Comments" puts forward the basic requirements for drug management : drug development, production, operation, use, and supervision and management activities should follow scientific requirements and ethical guidelines, comprehensively prevent and control risks, implement responsibilities, promote system construction, and improve management capabiliti.

The "Draft for Comments" separately sets up a special chapter for drug marketing authorization holders to refine the requirements for the holder's qualifications, the designation and change of domestic agents, and the fulfillment of obligatio.

Regarding the children's medicines and rare disease medicines that have attracted much attention, the "Draft for Comments" proposes that the state encourages the development and innovation of children's medicines, and the first approved new varieties, dosage forms and specifications for children, and increase children's adaptati.

The "Draft for Comments" further detailed regulations on other links in the whole chain of drug production, operation and supply guarant.

In the part of legal responsibility, the newly formulated and revised laws shall be implemented, and the penalty clauses shall be supplemented and improved; for the current "Regulations", the types of penalties, the extent of penalties and the intensity of penalties shall be increased in accordance with the requirements of the "four strictest"; The legal responsibilities of pharmacists who fail to dispense prescriptions as required, and illegal acts such as illegal packaging, labels, and instructions shall be refin.

Click "Read the original text" to view the full text of the draft