Medical network - 31 March 29, the state food and drug administration of management center of attestation of qualification of licensed pharmacists website "about 2017 to adjust the part of the national licensed pharmacists qualification exam outline announcement no. 1 (2017)", sina medicine is condensed the adjustment content arrangement is as follows: 

 

Focus: outline of the pharmaceutical affairs management and the laws and regulations 

 

The adjusted basis: the national licensed pharmacists exam outline (seventh edition)" 

 

+ the standing committee of the National People's Congress and the state council, food and drug supervision administration and national health family planning, human resources, social security and so on release of the eight new policy 

 

Adjust content: the concentration of drug use, drug tracing system, production circulation circulation of vaccines, YaoXie review the content of the examination and approval, the method of traditional Chinese medicine and other relevant laws and regulations to adjust (see article) at the end of the form 

 

Attached to inform the full text is as follows: 

 

About 2017 adjusting part of the national licensed pharmacists qualification exam outline announcement no. 1 (2017) 

 

To do a good job in 2017 countries practicing pharmacist qualification examination, entrusted by the state food and drug supervision and administration bureau, the state food and drug administration of management center of attestation of qualification of licensed pharmacists according to the national licensed pharmacists qualification exam outline (seventh edition) "(hereinafter referred to as the" outline ") rules to determine the licensed pharmacists in 2017 exam outline of pharmaceutical affairs management and regulations subject adjust some of the content. Must be approved by the state food and drug supervision and administration bureau, now notice is as follows: 

 

A, "outline" subject matter management and Chinese materia medica breakdown and points of exam content, involving the following new policies and regulations, in accordance with regulations of the new policy 

 

▍ (1) of the standing committee of the National People's Congress examined and approved the law 

 

The law of the People's Republic of China law of traditional Chinese medicine (December 25, 2016, the 12th session of the standing committee of the National People's Congress 25 meeting through). 

 

▍ (2) promulgated by the state council administrative rules and regulations and related regulations 

 

1. The state council on amending the < circulation of vaccines and immunization management regulations > decision "(state council order no. 668); 

 

2. The state council about print and distribute "much starker choices-and graver consequences-in" deepening medical health system reform plan circular (guo fa [2016] no. 78); 

 

3. "" much starker choices-and graver consequences-in" national drug safety planning "(guo fa [2017] no. 12); 

 

4. The state council general office on further reform and improve the pharmaceutical production circulation use policy several opinions (countries do hair [2017] no. 13). 

 

▍ (3) the food and drug supervision administration and national health, such as human resources social security department issued by the state family planning commission regulations and related regulations 

 

1. "on modifying < drugs management quality management standard > decision" (state food and drug supervision and management of the administration to 28); 

 

2. On the modified < drug management quality management > related refrigerated, frozen storage and transportation of drug management, and other five announcement of appendix file (state administration of food and drug supervision and administration of no. 197, 2016); 

 

3. The human resources and social security ministry about issued by the national basic medical insurance, inductrial injury insurance and maternity insurance drug catalogue (2017 edition) notice (people club department is sent [2017] no. 15). 

 

Second, the specific contents of the curriculum adjustment 

 

"Of the People's Republic of China on the method of traditional Chinese medicine", "the state council on amending the < circulation of vaccines and immunization management regulations > decision" on further reform and improve the use policy for producing and distributing medicines several opinions of the laws and regulations such as part of the assessment content, did not in the original curriculum requirements, the need to adjust. 

 

Adjust the content as follows: 

 

▍ (a) in the first big third small units, increase the fourth breakdown "state reform and improve the production circulation use drug policy" and the main points of the "use policy" on further reform and improve the pharmaceutical production circulation several opinions of the main content of ". 

 

▍ (2) in the second unit second smallest unit third breakdown, will be the third point "drug electronic supervision function and basic requirements of" changed to "the provisions of the drug tracing system". 

 

▍ (3) in the fourth unit first a small unit, the second breakdown "drug registration management" changed to "drug registration management and review of the examination and approval system reform, increase the point" pharmaceutical medical equipment review content of the reform of examination and approval. 

 

▍ (4) in the sixth largest unit first a small unit, increase the breakdown "legislation of Chinese medicine" and points the development policy of "accord with the characteristics of traditional Chinese medicine management system and" "the act of traditional Chinese medicine of traditional Chinese medicine (TCM) the provisions of the protection, development and inheritance of traditional Chinese medicine". The sixth largest units in the first four small "proprietary Chinese medicine management" changed to "proprietary Chinese medicine and Chinese medicine management of medical institutions", increase the point "of TCM preparation and use requirement" "medical institutions entrusted production requirements of TCM". 

 

▍ (5) in the seventh largest unit 6 small unit first breakdown, will "vaccine business qualification administration" "vaccine supply and sales scope and limits" "vaccine procurement documents" "management requirements of the vaccine cold chain" and so on four points, change to "vaccine circulation reform and procurement, supply and distribution requirements" and "full traceability system and the whole process of the vaccine cold chain storage and transportation management system" are two key points. 

 

▍ (6) in the first ten unit, unit increase in the first five small "violate the provisions of the method of traditional Chinese medicine related legal responsibility", add "held in violation of the traditional Chinese medicine clinics, concocted Chinese medicine yinpian, entrust the compound Chinese medicine preparation for the record management stipulated by the law responsibility" and "Chinese herbal medicine planting in the process of using high toxic pesticides are highly toxic, the legal liability of" two breakdown, increase "should be put on record and did not put on record, or for the record to provide false materials when the legal liability of" "the application of traditional process preparation for record in accordance with the stipulations of TCM or not in accordance with the requirements of the record filing materials indicate the compound Chinese medicine preparation of punishment" and "the illegal use of high toxic pesticides are highly toxic, legal responsibility" three key points of the (see attachment). 

 

Please take note. 

 

Attachment: 2017 national pharmaceutical affairs management and the outline of the licensed pharmacists qualification regulations subject content adjustment 

 

Administration of state food and drug supervision and administration of center of attestation of qualification of licensed pharmacists 

 

On March 28, 2017 

 

(public attributes: active public)