The National Medical Products Administration (NMPA) and the National Administration of Traditional Chinese Medicine recently co-issued a document to support the development of substitutes for rare and endangered traditional Chinese medicine (TCM) herbs.

According to the NMPA, rare and endangered TCM herbs play a unique role in the prevention and treatment of major diseases. In recent years, with climate change and changes in the natural environment, rare and endangered TCM herb resources are becoming increasingly depleted.

The document focuses on key varieties of TCM herbs, and proposes a range of substitutes to develop based on clinical medication needs and the availability of TCM resources and specific species.

Measures have been proposed to boost the R&D and utilization of substitutes for rare and endangered TCM herbs, such as strengthening industry-university-research cooperation, enhancing technical guidance, and accelerating review and approval.

The document encourages R&D innovation, supporting the inclusion of substitutes for urgently needed rare and endangered TCM herbs in relevant research projects. The research outcomes can be registered as TCM sci-tech achievements and priority will be given to recommend them for national awards if eligible.

The document proposes deepening collaborative innovation among industry, academia, and medical institutions to address key technological challenges, and accelerating the transformation and promotion of research results based on clinical medication and industrial needs.

Over the years, China has taken proactive steps to advance the research and regulatory framework for substitutes. For example, in 2023, the NMPA established an experts' panel for drafting supervision policies and technical requirements for substitutes for rare and endangered TCM herbs.

In the new document, provincial-level drug regulatory departments are required to strictly supervise the production quality of substitutes for rare and endangered TCM herbs, and enhance monitoring and evaluation of adverse drug reactions related to these species.

The agencies authorized to market drugs are expected to conduct in-depth post-marketing research and evaluation to improve the application and management of substitutes.