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

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
and international pharmaceutical businesses an alternative to relying on a Certificate of Pharmaceutical