Integrating traditional Chinese (herbal) medicines into risk-based regulation - With focus on non-clinical requirements to demonstrate safety

Author: Vivian Liu. nqan Fung

Doi: 10.63059/ctmj.2024.v7.i01.pp45-53

Abstract:

All parties involved in Hong Kong's (China) public health system agree that TCM plays a significant role. The government, academic institutions, and industry of Hong Kong (China) must work together if the city is to play a pivotal role in exporting Chinese pharmaceuticals to international markets. The opportunity for well-established and traditional herbal medicines to demonstrate a 'acceptable safe' status for registration in the European Union has been opened up with the release of the final version of the European Medicines Agencies guidance document. This document details the acceptance of minimum requirements to nonclinical packages in bibliographical applications. Regardless of whether they are eligible to be registered under the streamlined approach inside the European Union, many traditional Chinese medicines may be shown to be safe to use with this basic nonclinical package. For qualifying proprietary Chinese medicines (pCm) with a long history of usage, this article envisions integrating a streamlined assessment method into the current drug regulatory system in Hong Kong (China). Less demand for scientific resources is required for such integration that uses the minimal nonclinical package based on bibliographical data or expert reports to prove safety for pCm with a lengthy history of usage. 'First hand' evaluation in Hong Kong (China) for qualifying pCm gives local

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