Examination point 1: Drug supervision and management agency departments responsibilities
State drug supervision and management department is responsible for epidemic prevention and control of drugs, medical devices and other safety supervision and management.
The State Drug Administration is responsible for the special approval of vaccines and therapeutic drugs for the prevention of new crown pneumonia.
The health and wellness department is responsible for the overall planning of the prevention and control of the new crown pneumonia outbreak.
The State Administration of Industry and Information Technology is responsible for the management of the stockpile of medicines needed for the prevention and control of New Crown Pneumonia.
The China Academy of Food and Drug Administration and Research is responsible for the work related to the batch issuance of the vaccine.
The State Drug Administration Drug Evaluation Center is responsible for the acceptance and technical review of the new crown drug clinical trials, marketing authorization applications.
Exam point two: masks, protective clothing, forehead temperature gun, nucleic acid testing reagents and other medical devices
Medical masks, protective clothing, forehead temperature gun belongs to the second class of medical devices. Imported Class II medical devices need to be registered and listed to the national drug supervision department, the territory of the Class II medical devices need to be registered and listed to the provincial drug supervision department. In terms of business management (including wholesale and retail), Class II medical devices need to be filed with the municipal drug supervision department.
Nucleic acid test reagents are in vitro diagnostic reagents, and under the management of medical devices, generally belong to the third class of medical devices. Class III medical devices need to be registered with the State Drug Administration listed to the municipal drug supervision department for the record.
Examination Point 3: Drug Registration Categories
The popular proprietary Chinese medicines in epidemic prevention and control include Lianhua Qingdian capsule (granule), Shuanghuanglian oral solution and so on. These drugs involve the registration of Chinese medicines. The registration of Chinese medicines is categorized according to innovative Chinese medicines, new and improved Chinese medicines, ancient classical Chinese medicine compound preparations, and medicines with the same name and formula. Listed drugs added to the treatment of the new coronavirus as an indication, the need for additional applications to the State Drug Administration Drug Evaluation Center.
Lianhua Qingdian capsule (granule) is derived from the ancient classic prescription, therefore, in the management of traditional Chinese medicine, the management of ancient classic prescription Chinese medicine compound preparation may also become a question point.
Examination point 4: network drug transaction services
During the epidemic prevention and control period, the network drug transaction has become one of the main ways for people to buy drugs. Therefore, the network drug transaction service model has also become a hot topic. The network drug trading service model includes business-to-business (B-to-B), business-to-personal consumption (B-to-C), third-party platform for drug network trading, and online and offline linkage (O-to-O).
Examination Point 5: New Crown Vaccines? Vaccine Classification
New Crown Vaccine became the focus of attention both inside and outside the industry during the New Crown epidemic. It is inferred that this exam may involve vaccine-related knowledge points. Such as vaccine classification, vaccine development and production management, vaccine procurement and distribution, vaccine supervision and management of knowledge points.
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