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Why is Real-world Study Indispensable for Drug Regulatory Decision-making?

By YUTING CHEN|May 11,2023

Chongqing "Real-world evidence could become an indispensable part of the evidence of drug regulatory decision-making, to form a comprehensive, complete, and rigorous evidence chain, thereby improving the scientificity and efficiency of drug development and supervision," said Professor Tan Chongqing, Deputy Director of the Institute of Clinical Pharmacology of Central South University.

Real-world data evaluate the safety of medical products

The real-world study refers to collecting patient-related data in real-world settings to obtain evidence of the value of a medical product and its potential benefits or risks. Real-world evidence generated by Real-World Studies can be used to support drug research and development and regulatory decisions.

So far, the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and many other regulatory agencies around the world have carried out extensive practices on how to scientifically and rationally use real-world data to evaluate the safety of medical products.

For example, it can provide evidence of effectiveness or safety for new product approvals; also as evidence for modified instructions for approved products, including adding or modifying indications, changing doses, dosing regimens or routes of administration, adding new applicable populations, increasing effectiveness comparison information, adding safety information, etc.; as evidence to support regulatory decisions as part of post-marketing requirements, etc.

An excellent opportunity for real-world study development  

Western (Chongqing) Science City, the future of scientific and technological innovation and high-quality development of Chongqing, has been committed to developing the biomedical industry.

Since 2020, the Western (Chongqing) Science City has signed 70 biomedical industry projects. Among them are four 10-billion-level projects and 15 billion-level projects, with 37 of the world's and China's top 500 enterprises and 32 listed enterprises.

On May 8, Chongqing Aiyong Xingchen Standard Medical Service Co., Ltd., which settled in Western (Chongqing) Science City, signed a strategic agreement with Hunan Yunluo Information Technology Co., Ltd. 

In this signing, both parties will reach complementary advantages through cooperation and provide Marketing Authorization Holder (MAH) with comprehensive services for launched medical devices. They will achieve comprehensive and in-depth cooperation in Real-World Study services, such as post-marketing evaluation, data management and analysis, and pharmacoeconomics of drugs and devices.

For medical companies that pay attention to real-world study, the current policy environment and technological environment have ushered in a good opportunity for development.

On July 13, 2022, according to the official website of the National Medical Products Administration (NMPA), the innovative drug for bone marrow protection, triracillide hydrochloride for injection (CDK4/6 inhibitor), jointly developed by Simcere Pharmaceutical Group Limited and G1 Therapeutics was approved for conditional marketing in China.

The product was included in the pilot scope of clinical real-world data application in Boao Lecheng International Medical Tourism Pilot Zone, Hainan, in August 2021 and accepted the marketing registration application by the NMPA in November 2021. It had only taken eight months to be approved, which significantly shows that high-quality, real-world studies can accelerate the approval of drugs.


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