BEIJING, March 20 (Xinhua) According to the website of the Ministry of Human Resources and Social Security, National Medical Products Administration and the heads of relevant departments of the Ministry of Human Resources and Social Security answered questions from reporters on the Provisions on the Professional Qualification System for Licensed Pharmacists and the Implementation Measures for the Professional Qualification Examination for Licensed Pharmacists. The relevant person in charge said that this system revision has set up a connection plan for the transition between the old and new systems for technical secondary school education. The transition period will end on December 31, 2020, and candidates with technical secondary school education will no longer be accepted after 2020.
1. What is the background and significance of the revision of the System Regulations and Examination Measures?
A: The licensed pharmacist system in China was established in 1994. In 1999, the former National Medical Products Administration and the former Ministry of Personnel jointly revised the Interim Provisions on the Qualification System of Licensed Pharmacists and the Implementation Measures for the Qualification Examination of Licensed Pharmacists (No.34 [1999] of the People’s Republic of China, hereinafter referred to as "Document No.34"), which clearly stipulated that licensed pharmacists should implement a unified national outline, unified examination, unified registration and unified management. Over the years, licensed pharmacists have played an active role in guiding the public to use drugs safely and rationally and ensuring the quality and safety of drugs. By the end of 2018, the number of people who passed the licensed pharmacist qualification examination had reached 1.03 million.
With the implementation of new laws and regulations and the development of drug safety supervision, some new situations and problems have emerged in the work of licensed pharmacists, and Circular 34 has been unable to meet the needs of the construction and development of licensed pharmacists and supervision. First, with the development of China’s pharmaceutical higher education and the increasing demand for public medication safety, the admission conditions for licensed pharmacists stipulated in Document No.34 can no longer meet the requirements of the current situation. Second, in view of the outstanding problems in the management of licensed pharmacists, such as "certificate attachment" and the failure of enterprises to equip licensed pharmacists as required, Circular No.34 lacks corresponding punishment clauses and grass-roots supervision cannot be relied upon. Third, the administrative subject of the implementation of the current system has changed several times.
In order to meet the needs of reform and development, rationalize the management rights and responsibilities of licensed pharmacists, speed up the construction of licensed pharmacists, and ensure the safe and effective use of drugs by the public, the two departments revised Circular 34 on the basis of fully listening to opinions from many parties.
Two, compared with the original system, what are the main changes in the "system regulations" and "examination methods"?
A: First, improve the entry threshold for licensed pharmacists’ academic qualifications, adjust the minimum academic qualifications from technical secondary school to junior college, and appropriately increase the working years of candidates in related majors in pharmacy (Chinese pharmacy). The second is to carry out information management on the registration of licensed pharmacists nationwide, establish credit records of licensed pharmacists, and conduct credit management on practice activities. The third is to clarify the punishment measures for licensed pharmacists and practicing units, and to restrict licensed pharmacists with bad information records when applying for registration. The fourth is to strengthen the operability of linking the professional qualification of licensed pharmacists with the intermediate professional title of pharmacy. Fifth, it is clear that Hong Kong, Macao and Taiwan residents are treated equally with mainland residents when they participate in national licensed pharmacist qualification examination, registration, continuing education and practice. Sixth, adjust the examination period from two years to four years, and extend the examination period appropriately.
3. What are the specific requirements of the "Regulations" for the qualification examination of licensed pharmacists?
A: In order to improve the quality of licensed pharmacists, strengthen the professionalism of the team, and highlight the post practice requirements, this revision will adjust the entry threshold for licensed pharmacists’ academic qualifications from secondary school to junior college, and appropriately increase the working years of relevant professional candidates in pharmacy (Chinese pharmacy).
The "Regulations" clarify that all People’s Republic of China (PRC) citizens and foreigners who are allowed to work in China can apply for the professional qualification examination for licensed pharmacists if they meet one of the following conditions: (1) They have obtained a college degree in pharmacy and Chinese medicine, and have worked in pharmacy or Chinese medicine for 5 years; (two) to obtain a bachelor’s degree or bachelor’s degree in pharmacy or Chinese medicine, and to work in pharmacy or Chinese medicine for 3 years; (3) Having obtained the second bachelor’s degree, graduate class or master’s degree in pharmacy or Chinese pharmacy, and having worked in pharmacy or Chinese pharmacy for one year; (four) to obtain a doctorate in pharmacy and traditional Chinese medicine; (5) Persons who have obtained corresponding academic qualifications or degrees in pharmacy or traditional Chinese medicine will have their working years in pharmacy or traditional Chinese medicine increased by one year.
4. How do the Examination Measures stipulate the conditions for applying for some examination subjects with exemption?
A: The "Examination Measures" canceled the original working years for the conditions for applying for some examination subjects that are exempt from examination. In accordance with the relevant provisions of the state, those who have obtained senior professional titles in pharmacy or medicine and work in pharmaceutical posts may be exempted from taking the examination of pharmaceutical professional knowledge (1) and pharmaceutical professional knowledge (2), and only take the examination of pharmaceutical management and regulations and pharmaceutical comprehensive knowledge and skills; Those who have obtained the senior professional title of Chinese medicine or Chinese medicine and work in the post of Chinese medicine can be exempted from the examination of Chinese medicine professional knowledge (1) and Chinese medicine professional knowledge (2), and only take the examination of pharmaceutical affairs management and regulations and comprehensive knowledge and skills of Chinese medicine.
Applicants with senior titles who meet the requirements of exemption from the two subjects must work in pharmacy or traditional Chinese medicine and obtain senior titles in pharmacy or medicine, and their qualifications for senior titles should be obtained before the deadline for registration. Those who have worked in pharmacy or Chinese pharmacy and obtained senior professional titles in pharmacy or medicine but have not been employed in the corresponding positions may apply for the exam.
V. What transitional policies or measures are there for the applicants with technical secondary school education in this revision?
A: In order to protect the legitimate rights and interests of candidates, this system revision has set up a bridging scheme for the transition between the old and new systems for technical secondary school education, with the transition period ending on December 31, 2020. Those who meet the requirements of the original No.34 document and register for the examination in 2018 and 2019, the validity period of the examination results shall be implemented according to the original provisions of 2 years; Those who sign up for the exam in 2020 should complete all the exam subjects within that year, and will no longer accept candidates with secondary school education after 2020.
Six, how to manage the continuing education of licensed pharmacists, and how to effectively link the registration management with continuing education?
A: Licensed pharmacists should receive continuing education, update their professional knowledge and improve their professional level in accordance with the relevant provisions of the national continuing education for professional and technical personnel. The state encourages licensed pharmacists to participate in practical training. The continuing education credits of licensed pharmacists shall be recorded in the national licensed pharmacist registration management information system in time by the continuing education management institution.
7. How are the professional qualifications and professional titles of licensed pharmacists linked?
A: In order to implement the relevant requirements of the reform of the central professional title system and promote the effective connection between the professional qualification system and the professional title system, the "System Regulations" clearly stipulates that professional and technical personnel who have obtained the professional qualification of licensed pharmacists can be recognized as having the title of competent pharmacist or competent Chinese pharmacist, and can be used as a condition for applying for a higher-level professional title. The unit selects the best one according to the needs of the work.
Eight, the "Regulations" on the "Licensed Pharmacist Registration Certificate" linked to other acts of what punishment?
A: In order to solve the problem of law enforcement at the grass-roots level, the "Regulations on the System" stipulates a number of measures to solve the regulatory problems such as the on-the-job absence of licensed pharmacists and the affiliation of the Registered Certificate of Licensed Pharmacists. For example, the second paragraph of Article 13 stipulates that applicants for registration must abide by the law and discipline, abide by the professional ethics of licensed pharmacists, and have no bad information records. Article 26 stipulates that units that fail to equip licensed pharmacists according to regulations shall be ordered by the local drug supervision and administration department at or above the county level to equip them within a time limit, and shall be punished in accordance with relevant laws and regulations. Article 28 stipulates that if a licensed pharmacist registration certificate is obtained by cheating, bribery or other improper means, the licensed pharmacist registration certificate shall be revoked by the issuing department and the licensed pharmacist shall not be registered within three years; If a crime is constituted, criminal responsibility shall be investigated according to law. It is strictly forbidden to link the Licensed Pharmacist Registration Certificate. If the registered unit of the holder is inconsistent with the actual work unit, the Licensed Pharmacist Registration Certificate shall be revoked by the issuing department and recorded in the national licensed pharmacist registration management information system as personal bad information by the department responsible for drug supervision and administration. Units that buy, sell or lease the Licensed Pharmacist Registration Certificate shall be punished in accordance with relevant laws and regulations.
The "Regulations on the System" clarifies the punishment measures for the violations of licensed pharmacists and practicing units, so that grass-roots supervision has laws to follow. When applying for registration of licensed pharmacists with bad information records, the registration will not be approved until the bad information records are revoked. Through the establishment of licensed pharmacists’ integrity records and licensed pharmacists’ big data management, we will increase the crackdown on licensed pharmacists’ "hanging certificates" and establish a normalization mechanism for "hanging certificates" governance.
9. What are the new regulations for Hong Kong, Macao and Taiwan residents in this revision?
A: In order to further facilitate the work and life of Hong Kong, Macao and Taiwan residents in the Mainland (Mainland) and promote the technical exchange of pharmaceutical professionals and technicians, the "System Regulations" has specially added relevant provisions for Hong Kong, Macao and Taiwan residents to apply for the professional qualification of licensed pharmacists, making it clear that Hong Kong, Macao and Taiwan residents’ application for national licensed pharmacist qualification examination, registration, continuing education, practice and other activities, just like mainland (Mainland) residents, should be handled with reference to relevant regulations.
X. How to promote the follow-up work after the promulgation of the "System Provisions" and "Examination Measures"?
A: We will do a good job in the following four aspects: First, we will do a good job in organizing and implementing the system. Carry out various forms of publicity and policy interpretation, so that the majority of pharmaceutical technicians can fully know, understand and support the newly revised "System Provisions" and "Examination Methods". Second, taking the opportunity of system revision, we will carry out centralized rectification of licensed pharmacists in pharmaceutical retail enterprises to promote the healthy and benign development of licensed pharmacists’ professional qualification system. The third is to pay close attention to the revision of the "Administrative Measures for the Registration of Licensed Pharmacists" and other supporting documents. The fourth is to implement the development goals and tasks of licensed pharmacists in the "Thirteenth Five-Year National Drug Safety Plan", strengthen the supervision and inspection of licensed pharmacists in retail pharmacies, standardize the practice behavior of licensed pharmacists, and guide and urge enterprises to implement the main responsibility of licensed pharmacists.