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Summary of Annual Work of the Food and Drug Administration Regulations Section


Since the beginning of XX, the policy and regulations department has guided the spirit of the party's xx conference and Deng Xiaoping Theory and the important thinking of "xxxx", fully implemented the scientific development concept, and thoroughly implemented the spirit of the system-wide work conference and the party-style clean government construction work conference. Under the correct leadership, with the support and cooperation of the various brothers' offices, we worked closely around the global center, earnestly performed all duties, obeyed the overall situation and served the overall situation, and comprehensively promoted the administration of law as the core, and steadily advanced the year-round work.
First, earnestly carry out the "Regulations on Drug Supervision and Administration of Jiangsu Province" publicity and implementation, and create a good social atmosphere for the implementation of the "Regulations"
In XX, in conjunction with the actual situation of the "Regulations" officially implemented on May 1 this year, we strengthened active propaganda and positive guidance, and through solid and effective propaganda, the general public, administrative counterparts and drug regulatory staff fully understood The significance of implementing the "Regulations", accurately understanding the spirit and basic content of the "Regulations", constantly improving the awareness of drug control in the whole society, and creating a good public opinion atmosphere for the implementation of the "Regulations".
The propaganda work of the "Regulations" is under the unified leadership of the provincial bureaus. The cities, in combination with the actual work, through the newspapers, radio, television, Internet and other media, in the form of square consultation propaganda, training courses, lectures, competitions, etc., have plans, steps The launch.
At the beginning of the year, we organized and printed a single book of the "Regulations", and issued various offices of various cities, directly affiliated units, and agencies, and made solid preparations for publicity. From March 24th to 25th, a training course on the "Regulations" of the system-wide legal staff was held in Jiangning, Nanjing. Through training, the system-wide legal staff deeply understood the spirit and specific content of the "Regulations". In the training class, Assistant Director of the Provincial Bureau, Yu Shanlu, asked the legal staff to strengthen the study, while returning to the publicity and education of the "Regulations". On April 29th, the provincial bureau held a press conference to implement the "Regulations", and invited the major media in the province and the media in the Soviet Union to participate. Yu Shanlu, Assistant Director of the Provincial Bureau, presided over the meeting. The Deputy Director of the Provincial Bureau, Zhu Qinhu, and the head of the relevant department introduced the important significance of the legislation of the Regulations, the highlights of the regulations, the contents of the key norms, and the issues that were mainly solved. A reporter asked. In late April, the issue of the "Regulations" knowledge contest for the whole society was published in the Xinhua Daily, and the new local regulations were more widely publicized and popularized throughout the society through competition. At present, the competition has been successfully concluded. The knowledge contest attracted nearly 5,000 people from all over the country to participate in the examination. After the unified review of the scoring group, the notary public lottery of the Nanjing Notary Public Office produced 224 all the first, second and third prizes and commemorative awards, and was publicized through the website of the provincial bureau. It has achieved good results and effectively publicized the "Regulations", creating a good social atmosphere for the implementation of the "Regulations".
Second, improve centralized acceptance, standardize administrative licensing
In XX, we continued to carefully summarize the operation of the Administrative Licensing Acceptance Center since its establishment, analyze the existing deficiencies, take the initiative to go out, learn the advanced experience of the brother departments, and further standardize the overall administrative licensing with the actual situation. behavior. The first is to strengthen the construction of a centralized acceptance system. On the basis of the summary analysis of the work of the receiving center, combined with the advanced practices of other provinces, the system and procedures for the acceptance of administrative licensing were further improved, and the "Regulations on the Centralized Acceptance of Work of Jiangsu Food and Drug Administration" was revised and improved. In order to further clarify the requirements for handling various administrative licenses, it is convenient for relatives to apply for administrative licenses, organize and print the "Key Points for Acceptance of Administrative Licensing Projects", and publish them to the public to further standardize the acceptance of administrative licenses. The second is to steadily promote the centralized acceptance of administrative licenses. Xxxx years on drug entrusted processing and production approval, anesthetic drugs, psychotropic drugs experimental research project approval, export protein assimilation preparations, peptide hormone approval, accepting foreign companies entrusted production of protein assimilation preparations, peptide hormones filing, radiopharmaceutical production, business license review Two administrative licensing items, such as the examination and approval of preparations for the preparation of medical institutions, and the acceptance of two administrative confirmation items, such as the acceptance of processed pharmaceuticals by overseas pharmaceutical manufacturers and the handling of drug sales certificates, were implemented in a centralized manner. The third is to explore the reform of the system-wide administrative licensing system. Organizing the Municipal Bureau to implement the registration of licensed pharmacists and the sales certificate of medical device export products, simplifying the approval process and facilitating the relatives. The fourth is to deepen the convenience of the people. The convenience service window was set up at the reception center of the bureau, and the humanized service such as providing free access to the Internet, inquiring, and modifying electronic materials for the applicant received favorable comments.
In XX, the administrative licensing acceptance center received 3,756 cases and distributed 4,700 pieces of various materials. Among them, 1740 were registered in the registration window, 2279 pieces were issued, and 772 pieces were mailed; 1,249 pieces of medicine production and operation windows were accepted, and 1082 pieces of proof materials were issued; 767 pieces of medical equipment windows were accepted, and 567 pieces of proof materials were issued.
III. Promoting the openness of government affairs and promoting the open operation of administrative rights First, it has compiled a catalogue of public operation of administrative powers of the bureau, and clarified the responsible departments, responsible persons, public forms, and telephone numbers for each administrative licensing, administrative punishment, administrative reconsideration, etc. Further promoted the overall openness of government affairs. The second is to sort out the administrative confirmation items of 19 administrative licensing items of the bureau, and the main points of the 97 small items are reviewed. They are prepared to be published on the Internet gradually, so that it is convenient for the relatives to prepare the application materials. Draft the administrative power of the bureau to open the catalogue. Third, in coordination with the bureau's office, in accordance with the requirements of the “Regulations on the Disclosure of Government Information” promulgated by the State Council, the bureau's government information disclosure guidelines and public catalogues were prepared, and the bureau's information center was used to link the government affairs website to the government affairs website and the government information disclosure. Adapted and supplemented.
Fourth, solidly carry out grassroots research work, fully implement the requirements of the provincial party group to carry out the scientific development concept activities. The provincial bureau established this year as a system-wide "investigation and research year", according to the work requirements of the provincial party group on the "investigation and research year", and In the XX year, we combined the whole system policies and regulations to carry out the grassroots investigation and research work in the whole system, focusing on the status quo of the county-level bureau's legal work. On May 8th, we used the whole system policy and regulations work meeting to go to Zhenjiang Dantu and Danyang Bureau for investigation. On May 15th, they went to Taizhou City Bureau, Taizhou City Taixing and Jiangyan Bureau, May 22 to Changzhou City Bureau, Changzhou Wujin Bureau, June 11-12 to Suzhou Municipal Bureau, Suzhou Changshu, The Kunshan Bureau and other units understand the situation. The Xuzhou Municipal Bureau was also briefed on the legal work of other county-level law enforcement agencies in Xuzhou City, and formed a research article titled "The Status and Thinking of the Legal System Work of the County-Level Bureau of the Whole System" and the Party Committee of the Bureau. At the same time, according to the requirements of the provincial bureau “to carry out the second phase of work arrangement for the study and practice of the scientific development concept”, on the basis of the first stage of investigation and research and solicitation of opinions, we will study carefully by holding branch meetings and conducting branch meetings. I deeply understand the spirit of the speech of Director Li Jiping at the "Creation of Civilization Industry Activities and Organizational Work Style Construction Promotion Conference", closely related to the actual work, carefully analyze the problem of investigation, and "review" the implementation of relevant systems. On June 20th, the special organizational life meeting of the Party branch on the scientific development concept learning activities was held. In response to the problems of the previous stage of analysis and investigation, the next step of rectification was discussed, and the party group’s learning activities on the scientific development concept were completed in time. Task task.
V. Seriously organize and carry out the inspection work to meet the inspection of the administrative law enforcement responsibility system of the State Bureau, and fully promote the system-based administration according to the State Food and Drug Administration's "Notice on the Implementation of the Inspection of the Implementation of the Administrative Law Enforcement Responsibility System" and the leadership of the relevant bureaus. The requirements of our department, combined with the actual work of the whole system, formulated and issued the "Notice on the Implementation of the Inspection of the Implementation of the Administrative Law Enforcement Responsibility System", formulated a plan to meet the inspection of the National Bureau, and clarified the inspection contents, inspection methods, time schedules and work. Claim. According to the relevant requirements of the National Bureau, Yan Huaihu, the head of the discipline inspection team of the Bureau, and Yu Shanlu, the assistant to the director, convened a coordination meeting of the responsible persons of the department, and further sought the opinions and suggestions of the various departments on the administrative law enforcement responsibility system of the provincial bureau that had been initially completed. In-depth revision and improvement, on the basis of the original to achieve job setting, responsibility decomposition is more reasonable, and equipped with a work flow chart for each work program. At present, apart from the lack of a few flowcharts, accountability, and appraisal, the two systems are subject to the approval of the bureau leaders, and basically complete the formulation of the responsibility system. In xxxx years, the municipalities have completed the self-examination of the administrative law enforcement responsibility system in their respective systems. In the next step, we will conduct on-the-spot inspections of the provincial system in conjunction with the relevant departments.
6. Do a good job in the review and filing of normative archives, and guarantee the legality and rationality of the abstract administrative actions of the whole system. According to the "Regulations on the Filing of the Standardized Archives of Jiangsu Food and Drug Supervision and Management System", we will perform the normative and serious performance of the review submitted to our office. Reviewing the responsibilities, carefully scrutinizing the contents of the archives from a legal perspective, ensuring that the normative archives issued by the SIPO are not in conflict with national laws and regulations; on the other hand, we promote development by reviewing, formulating and cleaning up the normative archives. As a starting point, we strive to make the normative archives issued by our bureau conform to the principle of administrative efficiency, and have operability, and timely to the three notices of the "Notice on Strengthening the Market Access Supervision and Management of Pharmaceutical Wholesale Enterprises". The Archives reported to the Provincial Legal Office to conduct a record review. While doing a good job of the provincial bureau's normative file review, do a good job in reviewing the normative files filed by the municipal bureau, and promptly point out the corrections to the problems existing in the files.
7. Seriously handle the instructions of the grassroots bureau. Request for new problems and new situations discovered in grassroots law enforcement, seriously discuss and study, timely help solve specific problems encountered in the actual law enforcement process of grassroots law enforcement personnel, and avoid errors and misconduct in grassroots law enforcement. Since the beginning of this year, we have handled 6 basic bureaus' requests with the relevant business offices, responded with 5 pieces, approved 3 pieces in writing, and requested 1 national bureau.
8. Strengthening the building of party style and clean government and consciously preventing corruption.
Since the beginning of this year, our department has conscientiously implemented the spirit of the party-wide work style and clean government work conference, and has continued to strengthen and improve the party's work style and clean government construction in an in-depth manner. It has clarified that two meetings must be discussed, that is, the construction of the party's work style and clean government must be emphasized and the work style construction must be emphasized. All staff members are required to establish a correct view of power, interests and honor and disgrace, and to be law-abiding, honest and honest. Consciously carry out disciplinary education and learning activities, and establish the concept of "establishing the party for the public and law enforcement for the people", so as to prevent micro-duration.
Nine, other work
1. A meeting of the provincial system policies and regulations was held. From May 6th to 8th, the XX year provincial system policy and regulation work conference was held in Zhenjiang. The meeting summarized the achievements of the whole system policies and regulations in XX, analyzed the current situation, and how to make good policies this year. The regulatory work has been specifically deployed.
2. To undertake the answering work of the No. 0009 proposal of the 11th Provincial People's Congress.
3. Seriously do a good job in reviewing and handling the law enforcement documents of new system personnel and post adjustment personnel.
4. Do a good job in the administration of government information. In XX, a total of 11 pieces of government information were submitted.
5. Assist the National Bureau in completing the collection and reporting of the revised opinions collection and research topics of the Drug Administration Law.
In the second half of the year, we will continue to focus on the work of the Global Center and the work targets set at the beginning of the year, continue to promote the implementation of the Regulations, and supervise and inspect the implementation of the Regulations, actively strengthen the construction of the legal system, and further strengthen law enforcement supervision. Standardize administrative licensing and comprehensively promote the system-wide administrative work of the whole system.
First, continue to promote the propaganda and implementation of the "Regulations" in light of the actual supervision, and carry out further follow-up training of the "Regulations" from time to time to better serve the system-wide supervision and enforcement work. At the same time, all municipal and county bureaus are required to continue to carry out in-depth and extensively the work of propaganda and implementation of the "Regulations" and the work of social law.
Second, continue to promote the system-wide legal work institutions and team building. First, in accordance with the goals and requirements set by the "xxx" plan of the bureau, focus on comprehensively promoting the establishment of full-time legal staff at the county level, improve the legal work network, and protect the system according to law. The overall advancement of administrative work.
Second, according to the adjustment of the system personnel and the knowledge structure, continue to improve the training and exchange of staff of policies and regulations, and continuously improve the overall quality and work level of the staff of policies and regulations.
Third, strengthen law enforcement supervision, and further standardize administrative law enforcement behaviors First, further improve the administrative law enforcement responsibility system, combined with the system objectives management assessment work, implement the administrative law enforcement evaluation system. On the basis of full-scale self-examination before the completion of the inspection of the law enforcement responsibility system of the National Bureau, we will do our best to prepare for the inspection.
Second, strengthen law enforcement supervision, conduct self-inspection, cross-checking, superior supervision and other forms of supervision, carry out law enforcement inspections focusing on case file quality, administrative punishment, and administrative examination and approval, strengthen internal level supervision, and further standardize system-wide law enforcement behavior. Improve the level of law enforcement.
The third is to further standardize the exercise of the discretionary power of administrative punishment, and to follow up the implementation of the "Guiding Opinions on the Application of Administrative Punishment Discretion" issued by the provincial bureau to ensure the legality and rationality of administrative punishment.
Fourth, further standardize the system-wide administrative licensing work First, further improve the centralized acceptance work. For projects that have not been implemented in a centralized manner, it is clear that the provincial bureau accepts the center or entrusts the municipal bureau to accept the window for centralized acceptance. The “Regulations on the Centralized Acceptance of Work by the Jiangsu Food and Drug Administration” was issued to further improve the working procedures and systems of the acceptance center.
The third is to standardize the operation of the specific work of the municipal bureau in the administrative examination and approval of the bureau, establish a system for the provincial bureau to organize the municipal bureau to complete the specific work of the administrative license, and regulate the municipal bureau to undertake some specific work in the administrative examination and approval of the bureau. Operation.
The fourth is to promote the online acceptance and approval of administrative licenses. Actively cooperate with the business offices and bureau information centers, and on the basis of the preliminary work, do a good job in online acceptance and approval.
V. Promote the openness of the operation of the rights, ensure the transparency of the operation of the administrative rights, continue to improve the government affairs disclosure column, and the public service column of the service guide. The relevant administrative information such as the administrative authority list and the power operation flow chart are actually, practical, effective and innovative. It is required to adopt various forms of disclosure in accordance with local conditions and appropriate measures, and to increase the depth of government affairs disclosure.

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