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【分享】國家藥品監(jiān)督管理局機(jī)關(guān)各司局主要職責(zé)

2018-11-20 3409

來源: CCFDIE平臺(tái)

國家藥品監(jiān)督管理局機(jī)關(guān)各司局主要職責(zé)

    Principal responsibilities of the departments and bureaus of National Medical Products Administration

 

綜合和規(guī)劃財(cái)務(wù)司

 

負(fù)責(zé)機(jī)關(guān)日常運(yùn)轉(zhuǎn),承擔(dān)信息、安全、檔案、保密、信訪、政務(wù)公開、統(tǒng)計(jì)、信息化、新聞宣傳等工作。對重要政務(wù)事項(xiàng)開展督查督辦。組織開展應(yīng)急管理和輿情監(jiān)測工作。擬訂并組織實(shí)施發(fā)展規(guī)劃和專項(xiàng)建設(shè)規(guī)劃,推動(dòng)監(jiān)督管理體系和信息化建設(shè)。承擔(dān)機(jī)關(guān)和直屬單位預(yù)決算、財(cái)務(wù)、國有資產(chǎn)管理及內(nèi)部審計(jì)工作。組織起草綜合性文稿和重要會(huì)議文件。

Department of General Affairs, Planning and Finance

Responsibilities: 1.The daily operations of NMPA departments, undertaking the work related to information, security, confidentiality, public complaints and proposals, open government affairs, information technology, news publicity, etc. 2. Inspect, supervise and handle important government affairs. 3. Organize the implementation of emergency management and public opinion monitoring. 4. Mastermind, organize and implement development plans and special plans to drive the construction of administrative system and information system. 5. Undertake the budget and final accounts, finance, management of state-owned assets and internal audit for department organs and directly affiliated units. 6. Organize the drafting of documents of general affairs and important conference papers.

政策法規(guī)司

 

研究藥品、醫(yī)療器械和化妝品監(jiān)督管理重大政策。組織起草法律法規(guī)及部門規(guī)章草案。承擔(dān)規(guī)范性文件的合法性審查工作。承擔(dān)執(zhí)法監(jiān)督、行政復(fù)議、行政應(yīng)訴、重大案件法制審核工作。承擔(dān)行政執(zhí)法與刑事司法銜接管理工作。承擔(dān)普法宣傳和涉及世界貿(mào)易組織的相關(guān)工作。承擔(dān)全面深化改革的有關(guān)協(xié)調(diào)工作。承擔(dān)疫苗質(zhì)量管理體系QMS辦公室日常工作。

 

Department of Policies and Legal Affairs

Responsibilities: 1. Research of significant policies for supervision and administration of drugs, medical devices and cosmetics. 2. Organize the drafting of laws, regulations and departmental rules. 3. Legality review of normative documents. 4. Law enforcement supervision, administrative reconsideration, responding to administrative lawsuits, and legal audit of major cases. 5. Seamless integration of administrative law enforcement and criminal justice. 6. Work related to elevating legal literacy and legal publicity, and to the World Trade Organization. 7. Coordination of work relative to comprehensively deepening reforms. 8. Routine administration of the Vaccine QMS Office.

藥品注冊管理司(中藥民族藥監(jiān)督管理司)

 

組織擬訂并監(jiān)督實(shí)施國家藥典等藥品標(biāo)準(zhǔn)、技術(shù)指導(dǎo)原則,擬訂并實(shí)施藥品注冊管理制度。監(jiān)督實(shí)施藥物非臨床研究和臨床試驗(yàn)質(zhì)量管理規(guī)范、中藥飲片炮制規(guī)范,實(shí)施中藥品種保護(hù)制度。承擔(dān)組織實(shí)施分類管理制度、檢查研制現(xiàn)場、查處相關(guān)違法行為工作。參與制定國家基本藥物目錄,配合實(shí)施國家基本藥物制度。

 

Department of Drug Registration (Department of TCMs and Ethno-Medicines Supervision) 

Responsibilities: 1. Organize the formulation and supervise the implementation of drug standards and technical guidelines (such as Chinese Pharmacopoeia), formulate and implement drug registration management schemes. 2. Supervise the implementation of pharmaceutical non-clinical researches and Good Clinical Practice, the specifications for processing TCM slices; and implement the protection system for the categorization of TCM varieties. 3. Organize the implementation of the classified control system, inspect the R&D venues, and investigate and punish relevant illegal acts. 4. Participate in the development of the National Essential Drug List and cooperate in the implementation of the National Essential Drug System.

藥品監(jiān)督管理司

 

組織擬訂并依職責(zé)監(jiān)督實(shí)施藥品生產(chǎn)質(zhì)量管理規(guī)范,組織擬訂并指導(dǎo)實(shí)施經(jīng)營、使用質(zhì)量管理規(guī)范。承擔(dān)組織指導(dǎo)生產(chǎn)現(xiàn)場檢查、組織查處重大違法行為。組織質(zhì)量抽查檢驗(yàn),定期發(fā)布質(zhì)量公告。組織開展藥品不良反應(yīng)監(jiān)測并依法處置。承擔(dān)放射性藥品、麻醉藥品、毒性藥品及精神藥品、藥品類易制毒化學(xué)品監(jiān)督管理工作。指導(dǎo)督促生物制品批簽發(fā)管理工作。

 

Department of Drug Supervision

 

Responsibilities: 1. Organize the formulation and supervise, as per its powers and duties, the implementation of drug GMPs; organize the formulation and guide the implementation of the Good Supply Practice and Good Use Practice. 2. Organize and guide the on-site inspections over production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 4. Organize the monitoring of adverse reactions and law-based intervention thereof. 5. The supervision and administration of radioactive, narcotic, toxic, psychotropic drugs and pharmaceutical precursor chemicals.6. Guide and supervise the Registration Approval, Certificate Issuance and Product Release for biological products.

醫(yī)療器械注冊管理司

 

組織擬訂并監(jiān)督實(shí)施醫(yī)療器械標(biāo)準(zhǔn)、分類規(guī)則、命名規(guī)則和編碼規(guī)則。擬訂并實(shí)施醫(yī)療器械注冊管理制度。承擔(dān)相關(guān)醫(yī)療器械注冊、臨床試驗(yàn)審批工作。擬訂并監(jiān)督實(shí)施醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范、技術(shù)指導(dǎo)原則。承擔(dān)組織檢查研制現(xiàn)場、查處違法行為工作。

 

Department of Medical Device Registration

 

Responsibilities: 1. Organize the formulation and supervise the implementation of standards, classification rules, nomenclature conventions and coding rules for medical devices. 2. Draw up and implement the registration management system for medical devices. 3. Undertake the relevant medical device registration and clinical trial examination and approval. 4. Draw up and supervise the implementation of the Good Clinical Practice for Medical Devices and technical guidelines for medical device clinical trials. 5. Organize the inspection of R&D venues, investigate and punish the illegal acts.

醫(yī)療器械監(jiān)督管理司

 

組織擬訂并依職責(zé)監(jiān)督實(shí)施醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范,組織擬訂并指導(dǎo)實(shí)施醫(yī)療器械經(jīng)營、使用質(zhì)量管理規(guī)范。承擔(dān)組織指導(dǎo)生產(chǎn)現(xiàn)場檢查、組織查處重大違法行為工作。組織質(zhì)量抽查檢驗(yàn),定期發(fā)布質(zhì)量公告。組織開展不良事件監(jiān)測并依法處置。

Department of Medical Device Supervision

 

Responsibilities: 1. Organize the formulation and supervise, as per its powers and duties, the implementation of the GMPs for medical devices; organize the formulation and guide the implementation of the Good Supply Practice and Good Use Practice. 2. Organize and guide the on-site inspections over production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 4. Organize the monitoring of adverse reactions and law-based intervention thereof.

化妝品監(jiān)督管理司

 

組織實(shí)施化妝品注冊備案工作。擬訂并組織實(shí)施化妝品注冊備案和新原料分類管理制度。組織擬訂并監(jiān)督實(shí)施化妝品標(biāo)準(zhǔn)、分類規(guī)則、技術(shù)指導(dǎo)原則。承擔(dān)擬訂化妝品檢查制度、檢查研制現(xiàn)場、依職責(zé)組織指導(dǎo)生產(chǎn)現(xiàn)場檢查、查處重大違法行為工作。組織質(zhì)量抽查檢驗(yàn),定期發(fā)布質(zhì)量公告。組織開展不良反應(yīng)監(jiān)測并依法處置。

Department of Cosmetics Supervision

 

Responsibilities: 1. Organize and implement the record filling of cosmetic registration. 2. Draw up and organize the implementation of cosmetics registration record filing and classified control system for new materials. 3. Organize the formulation and supervise the implementation of standards, classification rules and technical guidelines for cosmetics. 4. Work out the cosmetic inspection system, inspect the R&D venues, perform duty-based organization and guidance over the on-site inspections of production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 6.  Organize the monitoring of adverse reactions and law-based intervention thereof.

科技和國際合作司(港澳臺(tái)辦公室)

 

組織研究實(shí)施藥品、醫(yī)療器械和化妝品審評、檢查、檢驗(yàn)的科學(xué)工具和方法。研究擬訂鼓勵(lì)新技術(shù)新產(chǎn)品的管理與服務(wù)政策。擬訂并監(jiān)督實(shí)施實(shí)驗(yàn)室建設(shè)標(biāo)準(zhǔn)和管理規(guī)范、檢驗(yàn)檢測機(jī)構(gòu)資質(zhì)認(rèn)定條件和檢驗(yàn)規(guī)范。組織實(shí)施重大科技項(xiàng)目。組織開展國際交流與合作,以及與港澳臺(tái)地區(qū)的交流與合作。協(xié)調(diào)參與國際監(jiān)管規(guī)則和標(biāo)準(zhǔn)的制定。

Department of Science & Technology and International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs)

 

Responsibilities: 1. Organize the study of scientific tools and methods for implementing the review, inspection and testing of drugs, medical devices and cosmetics. 2. Study and draw up the management and service policies encouraging new technologies and new products. 3. Work out and supervise the implementation of laboratory construction standards and GLPs, the qualification accreditation conditions and inspection specifications for the inspection and testing institutions. 4. Organize the implementation of significant science & technology projects. 5. Organize and carry out exchange and cooperation with the world and Hong Kong, Macao and Taiwan regions. 6.  Coordinate and participate in the development of international regulatory protocols and standards.

人事司

 

承擔(dān)機(jī)關(guān)和直屬單位的干部人事、機(jī)構(gòu)編制、勞動(dòng)工資和教育工作,擬訂人事管理及干部監(jiān)督制度并組織實(shí)施。統(tǒng)籌管理機(jī)關(guān)和直屬單位機(jī)構(gòu)編制,統(tǒng)籌管理工資、津貼補(bǔ)貼及直屬單位績效工資等。指導(dǎo)相關(guān)人才隊(duì)伍建設(shè)工作,統(tǒng)籌管理干部培訓(xùn),加強(qiáng)人才隊(duì)伍建設(shè)。承擔(dān)執(zhí)業(yè)藥師資格管理工作,負(fù)責(zé)執(zhí)業(yè)藥師資格準(zhǔn)入管理,制定執(zhí)業(yè)藥師資格準(zhǔn)入制度,指導(dǎo)監(jiān)督執(zhí)業(yè)藥師注冊工作。

Department of Human Resources

Responsibilities: 1. Undertake the personnel affairs of the cadres in department organs and directly affiliated units, institutional staffing, labor wages and education; formulate and organize the implementation of personnel management system and cadre supervision system. 2. Coordinate the management of institutional staffing for department organs and directly affiliated units; the wages, allowances and subsidies of NMPA; as well as the pay-for-performance in directly affiliated units. 3. Guide the construction of relevant qualified personnel teams, coordinate management of cadre training, and strengthen the construction of talent teams. 4. Undertake the qualification management of licensed pharmacists, take charge of the qualification management of licensed pharmacists, lay down the qualification admittance system for licensed pharmacists, guide and supervise the registration in this respect.

 

機(jī)關(guān)黨委

 

負(fù)責(zé)推進(jìn)機(jī)關(guān)和在京直屬單位黨的政治建設(shè)、思想建設(shè)、組織建設(shè)、作風(fēng)建設(shè)、紀(jì)律建設(shè),把制度建設(shè)貫穿其中。對黨員進(jìn)行教育、管理、監(jiān)督和服務(wù)。承擔(dān)黨風(fēng)廉政建設(shè)和反腐敗工作。指導(dǎo)直屬機(jī)關(guān)群團(tuán)組織開展工作,推進(jìn)精神文明建設(shè)。承擔(dān)局黨組巡視工作,負(fù)責(zé)內(nèi)部巡視的組織實(shí)施和中央巡視的協(xié)調(diào)配合。

Party committee

 

Responsibilities: 1. Promote the CPC political, ideological, organizational, work style-related, and disciplinary construction for NMPA organs and its directly affiliated units in Beijing, taking system construction as the mainline. 2. Conduct the management and supervision of CPC party members and provide education and service to them. 3. Undertake the Construction of Honest Party Conduct and Clean Government, as well as anti-corruption operations. 4. Guide the group league organizations (mass organizations) of NMPA directly affiliated organs to carry out work and promote the building up of spiritual civilization. 5. Undertake the inspection work of NMPA CPC Party Group, coordinate the organization and implementation of the internal inspection and the Central Party Committee inspection.

離退休干部局

 

負(fù)責(zé)機(jī)關(guān)離退休干部服務(wù)管理工作。負(fù)責(zé)機(jī)關(guān)離退休干部黨的建設(shè),承擔(dān)機(jī)關(guān)離退休黨員干部教育管理監(jiān)督工作。負(fù)責(zé)落實(shí)機(jī)關(guān)離退休干部政治、生活待遇,組織開展文化活動(dòng)。承擔(dān)機(jī)關(guān)離退休經(jīng)費(fèi)管理工作。指導(dǎo)直屬單位離退休干部工作。

Bureau of Retired Officials

 

Responsibilities: 1. Service management for retired (veteran) cadres. 2. Party committee construction for retired (veteran) cadres, as well as education and administration for retired (veteran) party members and cadres. 3. Put into effect the political status and material amenities of retired (veteran) cadres and organize cultural activities. 4. Funds management for retired (veteran) cadres of NMPA organs. 5. Direct the work relative to retired (veteran) cadres of NMPA directly-affiliated units.

2018年10月16日

(October16, 2018)