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深圳市藥品檢驗研究院簡介Shenzhen Institute for Drug Control

發布時間:2021-05-11 文章來源: 深圳市藥品檢驗研究院
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  深圳市藥品檢驗研究院(以下簡稱“深圳藥檢院”)原為深圳市藥品檢驗所,成立于1982年7月。2003年增設“深圳市醫療器械檢測中心”。2015年更名為“深圳市藥品檢驗研究院”。2017年獲批“中華人民共和國深圳口岸藥品檢驗所”。2018年成為全球第46家、中國第2家、地方第1家世界衛生組織藥品質量控制認證(WHO-PQ認證)實驗室。2020年成為國內首家聯合國藥品檢測全球長期合作實驗室。
  Shenzhen Institute for Drug Control (“SZIDC”) was established in July 1982. In 2003, Shenzhen Testing Center of Medical Devices (STCMD) was additionally opened. In 2015, the Chinese name of the Institute was changed. In 2017, the SZIDC was approved as the “Shenzhen Port Drug Inspection Institute of the People’s Republic of China”. In 2018, it officially became the WHO Prequalified (WHO-PQ) Quality Control Laboratory, which is the 46th in the world, the second in China and the first local WHO-PQ Quality Control Laboratory. In 2020, it became China’s first global drug testing laboratory of the United Nations Development Program (UNDP) for long-term cooperation.
  深圳藥檢院是法定的集藥品、醫療器械、化妝品檢驗和科研于一體的專業檢測機構,業務領域涵蓋國家、省、市監督、評價、應急檢驗,進口檢驗,國際組織委托的檢驗與科研,產品質量標準制修訂與檢驗研究,培訓教育及技術檢查,生物醫藥產業發展技術平臺建設等。實驗室建筑面積6.2萬平方米,各類大型精密檢驗儀器5000余臺/套,固定資產14.4億元。擁有WHO-PQ認證專家、歐洲藥典委員會委員、國務院政府特殊津貼、國家藥典委員會委員、國家級省級評審檢查員、博士生及碩士生導師等各類專家群體。
  The SZIDC is a legal professional organization for testing and scientific research of medicines, medical devices and cosmetics. Its main business domains include: national, provincial and municipal supervision/evaluation/emergency testing; import testing; testing and scientific research tasks entrusted by international organizations; revision and inspection of product quality standards; training, education, and technical inspection; construction of technology platforms for the development of the biomedicine industry. It has a total building area of 62,000 m2 for laboratories, with 5,000 sets of various large precision testing instruments, and fixed assets of RMB 1.44 billion. At present, a group of various experts are employed, including WHO-PQ certified experts, members from the European Pharmacopoeia Commission (EPC), experts enjoying special allowances from the State Council, members from the Chinese Pharmacopoeia Commission (CPC), national and provincial assessors and inspectors, supervisors of doctoral students and postgraduate students.
  通過實施“質量化、標準化、品牌化、國際化”發展戰略,搭建起國際、國內平臺基地30余個,建立LIMS系統為核心的實驗室信息化管理系統,實現從樣品受理、分發、數據記錄、審核、簽發涉及人、機、料、法、環、測等全過程的信息化動態管理。全國率先開發中藥檢驗自動化、信息化、智能化前處理系統,填補了國內中藥檢驗與智能化相結合的空白。實驗室先后通過CMA、CNAS、WHO等國內外權威部門和國際組織的認證認可檢查,檢驗檢測軟硬件條件、綜合實力位居全國藥檢系統第一方陣,檢驗技術能力、科研工作、實驗室體系管理、信息化建設等四大領域工作走在行業前列。
  By adhering to the “quality-oriented, standardized, branded and international” development strategies, the SZIDC has set up more than 30 international and domestic platforms and bases, and created the laboratory information management system with the LIMS system as the core, enabling the information-based dynamic management of the entire process from sample acceptance, distribution, data record and audit to issuance concerning 5M1E (man, machine, material, method, measurement and environment). It is the first in China to develop an automated, intelligent and information-based pretreatment system for testing of traditional Chinese medicines, filling the gap in China in the combination of TCM testing and intelligence. The laboratory has successively been certified and accredited by CMA, CNAS, WHO, other Chinese and foreign authoritative organizations, and international organizations. The SZIDC is at the forefront the industry in four major aspects - testing technical competence, scientific research, laboratory system management and information construction, with its inspection and testing software and hardware and comprehensive strength ranking top in China’s drug testing system.
  遵循“檢驗依托科研,科研提升檢驗”的方針,通過多年的發展,取得多項開創性科研成果。是地方藥檢機構首家國家博士后科研工作站設站單位,立足培養藥檢領域高層次人才;獲批“中藥質量研究與評價重點實驗室”、“化妝品監測評價重點實驗室”、“仿制藥評價生物等效性重點實驗室”3個國家藥品監督管理局重點實驗室,建成9個省級重點實驗室。完成13項《國際藥典》、全球基金藥品質量標準研究,制修訂產品質量標準700余項;獲授權國家發明專利、美國專利、PCT專利20項;獲省級一、二、三等科技進步獎及專利獎7項;其他獎勵100余項。與聯合國、世界衛生組織以及美國、德國、日本、香港、澳門等國際組織、知名院校開展了多領域、深層次的合作交流。
  Committed to the guideline of “basing testing work on scientific research and improving testing work through scientific research”, the SZIDC has made many groundbreaking achievements in in scientific research after years of development, and is the first among local drug control institutions to set up the national post-doctoral workstation, focusing on the training of high-level talents in drug testing domain. It has been approved by the National Medical Products Administration as the “Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine”, “Key Laboratory for Bioequivalence Research of Generic Drugs” and “Key Laboratory for Monitoring and Evaluation of Cosmetics”, and has established 9 provincial key laboratories. Moreover, the SZIDC has completed the research on quality standards for 13 species included in the International Pharmacopoeia and Global Fund, developed and revised more than 700 product quality standards; obtained 20 national invention patents, US patents and PCT patents, 7 provincial awards for progress in science and technology and patent awards (first, second and second place), and more than 100 other awards. It has conducted deep exchanges and cooperation in many fields with the United Nations, the World Health Organization, other international organizations and prestigious universities in the United States, Germany, Japan, Hong Kong and Macau.
  “十四五”期間,深圳藥檢院將以習近平新時代中國特色社會主義思想為指導,堅持高質量發展理念,抓住“雙區”建設重大歷史發展機遇,以“大開放、大平臺、大合作”的方式,持續提升藥品全生命周期監管檢驗能力和生物醫藥產業發展技術平臺能力,在支撐政府監管、促進產業發展、保障公眾健康等方面譜寫新的篇章。
  During the “14th Five-Year Plan” period, the SZIDC, under the guidance of President Xi Jinping’s “Thought on Socialism with Chinese Characteristics for a New Era” and in line with the “high-quality development” philosophy, will strive to seize the major historical opportunity created by the construction of Guangdong-Hong Kong-Macao Greater Bay Area and the Pilot Demonstration Area of Socialism with Chinese Characteristics, and continue to seek constant improvement in its “drug lifecycle supervisory testing capability” and “technical platform capability in biomedicine industry development”, to write a new chapter in supporting government supervision, promoting industry development, and protecting public health.
                                                                                                                                                                   2021年3月
                                                                                                                                                                  March 2021

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