China is closely aligning its new drug registration and review systems with international standards, opening new global markets for Chinese pharmaceuticals, according to the country’s medical products’ regulator.
In 2025, China's National Medical Products Administration (NMPA) joined the Medical Dictionary for Regulatory Activities’ (MedDRA) Steering Committee at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
By the end of 2025, China had fully implemented 73 of the agency’s technical guidelines, as it worked to align its technical standards for new drug registration and review with international norms.
Known as the "common language" for regulating the global pharmaceutical industry, the ICH ensures that regulatory bodies worldwide use the same technical standards and recognize each other's clinical trial data.
"In 2025, we issued 49 technical guidelines for drug research and development, covering areas such as radio-pharmaceuticals, cell and gene therapy products, traditional Chinese medicine, drugs for rare diseases, and pediatric drugs. Until now, we have released more than 600 guidelines," said Bai Yu, director of the Quality Management Division of the Center for Drug Evaluation at NMPA.
New technical guidelines issued by China in 2025 focused primarily on cutting-edge products and technologies for the international market, including innovative gene therapy drugs, peptide drugs, and antibody drugs.
"In 2025, we formulated and issued technical guidelines for clinical trials of gene therapy products treating thalassemia, as well as clinical pharmacology guidelines for peptide drugs and antibody-drug conjugates," said Geng Ying, deputy director of the chemical clinical division at the Center for Drug Evaluation.
Yang Zhimin, deputy director of the Center for Drug Evaluation, said the alignment of China’s pharmaceutical industry with international standards will drive the development of the nation’s medical and pharmaceutical industries.
"Under the principles of being innovation-driven, internationally aligned, and patient-centered, China's drug evaluation system has been continuously driving industrial development. With continued innovation in pharmaceutical regulatory science, China's new drugs will increasingly benefit patients around the world,” she said.
China aligns drug registration, review with global standards to open global markets to local producers
