Guangdong introduced: drug professional inspectors team construction implementation program set up 5 inspection offices

Medical Network January 22nd, the following is worthy of attention excerped: the provincial drug regulatory bureau guangdong east, guangdong west, guangdong north, Guangzhou, Shenzhen drug inspection office is responsible for the region's drug-related links on-site inspection, review work, investigate and punish related violations;
...... The Provincial Drug Administration can actively enrich the team of inspectors, innovate the selection of talents, implement a three-year phased plan of action for the expansion of the high-level inspection team, and vigorously train and recruit drug inspectors with high-risk drug inspection skills and practical experience, such as training and recruitment of high-risk drug inspection skills and practical experience.
And according to the professional level, business ability, job qualifications and performance, the inspectors are divided into junior inspectors, intermediate inspectors, senior inspectors, expert-level inspectors 4 levels, each level is subdivided into several levels, corresponding to different conditions of service, duties, technical titles and assessment standards, enjoy the corresponding remuneration.
in accordance with the post access and conditions of employment established by the drug regulatory department under the State Council, the administration of administrative law enforcement certificates and inspectors' qualification certificates shall be implemented, and a team of professional and specialized drug inspectors shall be built with high standards and requirements.
the pay level of full-time inspectors is linked to the technical title of inspectors, the ease of inspection work and the amount of inspection tasks, and the salary incentive mechanism is constructed to tilt to the first line of on-site inspection.
-time inspectors to participate in the provincial co-ordination of drug inspection tasks, the relevant treatment may be carried out by reference to the relevant provisions of external experts on similar matters.
The following is the original text: Guangdong Provincial People's Government Office on the issuance of Guangdong Province to promote professional professional drug inspectors team construction implementation program notice Guangdong Office letter (2020) No. 331 all over the listed people's government, provincial government departments, agencies directly under the authority: "Guangdong Province to promote professional professional drug inspectors team construction implementation plan" has been agreed by the provincial people's government, is now issued to you, please seriously organize the implementation.
problems encountered in the implementation process, please take a radial report to the provincial drug regulatory bureau.
, December 28, 2020, Guangdong Province to promote the construction of professional professional drug inspectors implementation program for the in-depth implementation of the General Office of the State Council on the establishment of professional professional drug inspectors team opinions (State Office issued (2019)36 No.), the establishment of provincial professional specialized drugs (including medical devices, cosmetics, the same below) inspectors, further improve the drug regulatory system mechanism, promote the modernization of the drug regulatory system and regulatory capacity in our province, promote the construction of the province's strong biopharmaceutical province, is proposed the following implementation plan.
, the overall requirements (i) guiding ideology.
Guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, we will fully implement the spirit of the Second, Third, Fourth and Fifth Plenary Sessions of the 19th National Congress of the Communist Party of China, follow the decision-making and deployment of the CPC Central Committee and the State Council on strengthening drug safety supervision, follow the laws of scientific supervision, deepen the reform of the drug regulatory system and mechanism, adhere to strict prevention at the source, strict control of process control, strict control of risks, strengthen drug safety supervision and inspection, and effectively safeguard the health and safety of the people.
(ii) the main objectives.
Adhere to the direction of professionalism and professional, technical requirements, by 2022, to build a basic to meet the requirements of drug supervision of professional professional drug inspectors team system, further improve the full-time inspectors as the main body, part-time inspectors as a supplement, political excellence, excellent quality, excellent business, clean and efficient professional professional drug inspectors team, the formation of clear responsibilities, smooth collaboration, covering the province's drug supervision and inspection system, to promote the province's high-quality pharmaceutical industry to provide strong support.
, improve the drug inspection system mechanism (iii) to establish a team of professional and specialized drug inspectors at the provincial level.
provincial drug regulatory bureau set up a team of professional and specialized drug inspectors at the provincial level, in accordance with the requirements of drug control throughout the key training, for drug supervision and administrative law enforcement to provide technical support.
basis, focus on strengthening the construction of high-risk drug inspectors such as vaccines.
(led by the Provincial Market Supervision Bureau and the Provincial Drug Administration, with the cooperation of the provincial party committee, the provincial judicial department and the provincial human resources and social security department) (iv) to strengthen the construction of inspection institutions.
Provincial Drug Administration Guangdong East, Guangdong West, Guangdong North, Guangzhou, Shenzhen Drug Inspection Office is responsible for the region's drug-related links on-site inspection, review work, investigation and punishment of related violations;
(led by the Provincial Market Supervision Bureau and the Provincial Drug Administration, with the cooperation of the provincial party committee) (v) to clarify the division of inspection powers.
Provincial Drug Administration is responsible for on-site inspection of drug, medical equipment, cosmetics research and development process, on-site inspection of the production process, compliance inspection of the implementation of production quality management practices, on-site inspection of pharmaceutical wholesale enterprises, retail chain headquarters, Internet sales third-party platform related on-site inspection, vaccines and other high-risk drugs The production process of resident inspection and daily inspection and other work, the implementation of more stringent on-site inspection, information publicity, adverse reaction monitoring reports and other systems, to guide the municipal and county-level market regulatory departments to carry out drugs, medical equipment, cosmetics operations, use of the link on-site inspection, as well as the implementation of relevant business quality management norms compliance inspection.
drug inspection matters of the Provincial Drug Administration shall be borne by the provincial financial department.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial party committee, the provincial finance department to cooperate) (vi) to implement the inspection requirements.
Provincial Drug Administration formulates and perfects the rules and procedures for drug inspection, and guides provincial inspection agencies to establish inspection quality management systems in accordance with international standards.
Strengthen the quality and safety risk management of the whole process of pharmaceutical products, carry out "double random, one open" supervision for special inspection, flight inspection and other work, accelerate the promotion of intelligent supervision of drugs based on information technology such as cloud computing, big data, "Internet plus" and improve the efficiency of supervision and inspection.
strengthen the equipment and use of mobile terminals and process recording equipment, make full use of information resources and data analysis technology, promote the standardization and standardization of on-site inspection work, and comprehensively promote the openness of regulatory enforcement.
to speed up the improvement of the internal whistleblower system.
The team of drug inspectors shall carry out on-site inspection of drug registration, on-site inspection of vaccine drugs, as well as local inspection and overseas inspection requirements, actively cooperate with drug supervision and inspection, implement the requirements for inspection, and provide technical support for scientific supervision and investigation of drug violations in accordance with the law.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial judicial department, the provincial government service data bureau) (seven) innovative inspection work mechanism.
provincial drug regulatory bureau to establish a unified provincial inspector's library and inspector information platform, to achieve the national inspector's library of information sharing and inspection coordination.
establish and improve the unified deployment and use mechanism of inspectors, according to the needs of the work to coordinate the deployment of inspectors to carry out inspection work.
the higher-level drug regulatory department may, in accordance with the needs of the work, mobilize the lower-level drug regulatory department to carry out the inspection work, and the lower-level drug regulatory department may apply to the higher-level drug regulatory department for on-site guidance by sending inspectors.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial government service data bureau in cooperation) III, the implementation of inspectors configuration (8) reasonable determination of the size of the team.
According to the supervision authority, the scale of the pharmaceutical industry and inspection tasks, establish scientific measurement methods, reasonably determine the size of the professional and specialized drug inspectors and adjust them dynamically in due course, and strengthen the staffing of the full-time drug inspectors on the basis of overall consideration of the existing drug regulatory personnel and establishment at all levels, reasonably safeguard the needs of the work, and equip the production enterprises with corresponding quantities of drug inspectors with high-risk drug inspection skills and practical experience such as vaccines.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial committee, the provincial finance department, the provincial human resources and social security department to cooperate) (9) to standardize the preparation and management of inspectors.
, we should give full consideration to the public welfare attributes of drug inspection work, and consider the staffing of drug inspection institutions in an integrated way according to the needs of the inspection work.
strict implementation of the preparation management requirements, take various forms to ensure the needs of inspectors, attract, stabilize the backbone of inspection and high-level inspectors.
innovative inspector management mechanism, the implementation of inspectors staffing, contract employment and government purchase inspection services (including co-construction inspection services) to optimize the structure of inspectors to ensure the stability of the team of inspectors.
(provincial market supervision bureau, provincial drug regulatory bureau led by the provincial committee, provincial finance department, provincial human resources and social security department with) (10) multi-channel to enrich the professional professional drug inspectors team.
in accordance with the "phased implementation, step by step in place" principle, in strict accordance with the corresponding qualification conditions, planned and step-by-step enrichment of professional professional drug inspectors.
The Provincial Drug Administration can actively enrich the team of inspectors, innovate the selection of talents, implement a three-year phased action plan for the expansion of the high-level inspection team, and vigorously train and recruit drug inspectors with high-risk drug inspection skills and practical experience, such as vaccines, by directly transferring qualified supervisors, training and evaluating relevant professionals within the regulatory authorities, open recruitment to the public, introduction of high-level talents, rotation exchanges, etc.
(led by the provincial market supervision bureau, provincial drug regulatory bureau, the provincial provincial committee, the provincial human resources and social security department in cooperation) to encourage the city and county originally engaged in drug production, wholesale supervision of the inspection (supervision) personnel to join the provincial professional professional drug inspectors, the establishment of the provincial drug regulatory bureau as the main body, to absorb the market regulatory departments at all levels with the corresponding drug inspection qualification personnel to participate in the inspection team system, the implementation of the administrative region drug production and other regulatory requirements.
qualified personnel managed by the market supervision departments at all levels may be used as part-time inspectors at the provincial level and included in the deployment and use of the provincial inspectors' library.
same time, from the drug regulatory administrative organs, scientific research institutions, inspection and testing institutions, institutions of higher learning, medical institutions to employ qualified personnel as part-time inspectors, to provide an important complement to the team of full-time inspectors.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial party committee, the provincial human resources and social security department in cooperation) IV, strengthen the management of the inspector team (11) to implement the classification management of inspectors.
According to the classification management system of inspectors of the drug regulatory department under the State Council, taking full account of the general and professional characteristics of inspectors, according to the inspection varieties, the inspectors are divided into three inspection sequences of drugs, medical devices and cosmetics, and according to professional level, business ability, work qualifications and performance, etc. In the case of the situation, the inspectors are divided into junior inspectors, intermediate inspectors, senior inspectors, expert-level inspectors 4 levels, each level is subdivided into several levels, corresponding to different conditions of service, duties and authority, technical titles and assessment standards, enjoy the corresponding remuneration.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial human resources and social security department in cooperation) (12) strict inspector post access management.
in accordance with the post access and conditions of employment established by the drug regulatory department under the State Council, the administration of administrative law enforcement certificates and inspectors' qualification certificates shall be implemented, and a team of professional and specialized drug inspectors shall be built with high standards and requirements.
Provincial Drug Administration should comprehensively examine the ideological character, professional quality, professional ability, professional quality, compliance with the law and other conditions of the proposed inspectors, fully implement the inspection personnel training and after passing the examination of the induction system, strictly professional professional drug inspectors team entrance quality control.
(led by the Provincial Market Supervision Bureau, the Provincial Drug Administration, with the cooperation of the Provincial Department of Justice) (13) to establish a scientific and reasonable assessment and evaluation and grade lifting mechanism.
the provincial professional professional drug inspectors team to carry out a graded assessment.
scientifically set up appraisal indicators, establish an appraisal and evaluation system based on job responsibilities, focus on performance contribution, combine daily assessment with year-end assessment, competency evaluation and performance appraisal, and implement diversified assessment.
pay attention to the assessment of the inspector's professional ethics, ability to perform their duties, professional skills, job performance and so on.
establish a grade lift system combining skills assessment and performance appraisal, as well as an exit system for unqualified inspectors, and the grade adjustment is linked to the evaluation results.
(the provincial market supervision bureau, the provincial drug regulatory bureau led by the provincial human resources and social security department to cooperate) five, and constantly improve the quality of inspectors (14) to strengthen the inspection of business training.
focus on improving inspection capacity, graded classification to carry out drug inspector training, the establishment of a unified standard professional drug inspector training system, the construction of teaching, learning, training, inspection and integration of education and training mechanism.
innovative training methods, the establishment of pre-job training and daily training system for inspectors, the first-time inspectors through the unified pre-job training and passed the examination, can obtain the provincial drug regulatory bureau confirmed the inspection work qualifications.
provincial drug regulatory bureau set up provincial professional professional inspector training institutions, increase the training of teachers, build a life-long training system.
are trained in business knowledge, laws and regulations for not less than 60 hours per year.
in 2022 to establish no less than 3 inspectors training base, highlighting the inspection work simulation practice training, strengthen the training process management and assessment, establish a unified inspector training file, and effectively improve the effectiveness of training.
(provincial market supervision bureau, provincial drug regulatory bureau responsible) (15) to encourage inspectors to consciously improve the level of ability.
to formulate specific measures to encourage inspectors to improve their professional quality and inspection capabilities, and to mobilize their enthusiasm and self-awareness to participate in intensive training, professional further education and self-study.
the implementation of the inspector training assessment system, and further strengthen the use of learning and training results in the year-end assessment, promotion and evaluation first, grade adjustment, promotion and other links.
(provincial market supervision bureau, provincial drug regulatory bureau responsible for) (16) innovative high-quality inspector training model.
Provincial Drug Administration to formulate medium- and long-term talent development plans for inspectors, innovative sharp-point type, all-round high-quality inspector training model.
joint training mechanism with institutions of higher learning and scientific research institutions to reserve high-quality inspection personnel.
actively rely on relevant international and non-profit organizations to develop high-level inspectors who are deeply involved in international regulatory affairs.
(provincial market supervision bureau, provincial drug regulatory bureau responsible for) six, the establishment of incentives