Medical network on April 7 - 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 supervision and management of administration 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 

 

(a) of the National People's Congress standing committee passed 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), administrative regulations and relevant provisions promulgated by the state council 

 

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", adding "held in violation of the traditional Chinese medicine clinics, concocted Chinese medicine yinpian, entrust the compound Chinese medicine preparation for the record management provisions of 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 

大单元	小单元	细  目	要   点
一 执业药师与药品安全	（三）药品与药品安全管理	4.国家改革完善药品生产流通使用政策	《关于进一步改革完善药品生产流通使用政策的若干意见》的主要内容
二 医药卫生体制改革与国家基本药物制度	（二）国家基本药物制度	3.基本药物质量监督管理	（3）药品追溯体系的规定
四 药品研制与生产管理	（一）药品研制与注册管理	2.药品注册管理与审评审批制度改革	（1）药品医疗器械审评审批改革内容
六 中药管理	（一）中药与中药创新发展	2.中医药立法	（1）符合中医药特点的管理制度和发展方针 （2）《中医药法》对中药保护、发展和中医药传承的规定
	（四）中成药与医疗机构中药制剂管理	2.医疗机构中药制剂管理	（1）中药制剂配制和使用要求 （2）医疗机构中药制剂委托生产要求
七特殊管理的药品管理	（六）疫苗的管理	1.疫苗的流通管理	（2）疫苗流通方式改革和采购、供应、配送要求 （3）疫苗全程追溯制度和全程冷链储运管理制度
十  药品安全法律责任	（五）违反中医药法相关规定的法律责任	1.违反举办中医诊所、炮制中药饮片、委托配制中药制剂备案管理规定的法律责任	（1）应当备案而未备案，或者备案时提供虚假材料的法律责任 （2）应用传统工艺配制中药制剂未依照规定备案或未按照备案材料载明的要求配制中药制剂的处罚
		2．中药材种植过程中使用剧毒、高毒农药的法律责任	违法使用剧毒、高毒农药的法律责任