Sumitomo Pharma (Suzhou) Co., Ltd. conducts clinical trials in compliance with the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guideline, and the laws, regulations, and guidelines of relevant countries. The company obtains permission from the drug administration authority, ethical approval from the research center, and appropriate consent from the subjects before the clinical trial.
Sumitomo Pharma (Suzhou) Co., Ltd. conducts clinical trials following the Declaration of Helsinki, the Good Clinical Practice (GCP) guideline, the Personal Information Protection Law, and other relevant laws and regulations. The company gives due consideration to the protection of human rights and personal information and privacy of clinical trial subjects and ensures the protection of their personal information and privacy through proper management of clinical trial data.
Sumitomo Pharma (Suzhou) Co., Ltd. adopts a global quality assurance system and adheres to the standard operating procedures and standard working instructions (SOPs and SWIs) in clinical trials. The company conducts regular monitoring, quality control, and auditing of clinical trials, and provides appropriate staff education and training.
Sumitomo Pharma (Suzhou) Co., Ltd. complies with the relevant laws and regulations on human genetic resources management of the countries in which it functions to effectively protect and rationally utilize the human genetic resources and to safeguard public health, national security, and the public interest of the society.
Sumitomo Pharma (Suzhou) Co., Ltd.'s quality assurance goal is to continuously improve the quality of its products and services, constantly enhance its quality management system, systematically implement all the requirements for drug registration regarding safety, efficacy, and quality control throughout the entire process of drug production, controlling drugs, product release, storage, and shipment to ensure that the manufactured drugs meet the intended use and registration requirements, supplying high-quality and efficient drugs to human health.
As a wholly owned subsidiary of Sumitomo Pharma (Suzhou) Co., Ltd. in China and a domestic agency for overseeing drug marketing authorization holders, the company significantly contributes to the global pharmacovigilance system.
In order to scientifically implement the management and monitoring of the whole life cycle of drugs, fulfill the requirements of Chinese national laws and regulations as well as local regulations and guidelines, and assume responsibility and obligation of the company as the responsible party for drug safety, we have established various pharmacovigilance management systems through nearly a decade of development, and formed a complete, systematic, and effective pharmacovigilance system together with the pharmacovigilance of the overseas holders from the head offices and related departments to provide technical support and scientific assurance for the rational and safe use of drugs by Chinese patients.
We always put patient safety first, practice our "patient-centered" management philosophy, and fulfill our responsibilities and obligations.
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