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.
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.
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.
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.
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.