Sino-Europe Symposium on Traditional Chinese Medicine & Herbal Medicine

The symposium held from 25thto 26th, March 2019 in Yale Center Beijing provided an open dialogue between representatives of the national competent authorities and industries with respect to regulatory requirements for the authorization of traditional Chinese medicine (TCM) and traditional herbal medicinal products in China as well as in Europe, aiming at optimizing mutual understanding of the different herbal systems and ideally harmonizing views on similar quality control, clinical research and safety, herbal marketing and regulatory policies.

The TCM regulatory environment in China and the regulatory environment for herbals are special and have different requirements for approval compared to the NCE. There is some overlap in the TCM and herbal products. Nevertheless the approval requirements for herbals in China are very challenging. This resulted in no herbal products approved for more than 10 years. TCM approvals in Europe have been taken place.

The symposium provided the opportunity to give the participants a better overview of the current situation and defining a path forward to mutual recognition. The program contained following 4 topics of discussion: 1. Market overview and regulation policy; 2. Quality control; 3. Clinical study and safety consideration; 4. Anti-counterfeit and international cooperation.

The two-day conference further included experts from Chinese National Medical Products Administration (NMPA), Federal Institute for Drugs and Medical Devices, European Directorate for the Quality of Medicines and Healthcare (EDQM), pharmaceutical industry, academia's, pharmacopeia and health authority speakers on how to improve the actual status of global access to TCM's and herbals and its strategy and next steps.

The Journal (World Journal of Integrated traditional and western Medicine) (English Version) will report the main contents of the symposium.