Zhong Linda L D, Lam Wai Ching, Lu Fang, Tang Xu Dong, Lyu Aiping, Bian Zhaoxiang, Boon Heather
Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, Hong Kong, China.
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China.
Front Med (Lausanne). 2021 Mar 9;8:617625. doi: 10.3389/fmed.2021.617625. eCollection 2021.
Chinese Medicine plays a symbolic role among traditional medicines. As Chinese Medicine products are widely used around the globe, regulations for Chinese Medicine products are often used as models for the efficient regulation of natural products that are safe, and high-quality. We aimed to compare the regulatory registration requirements for Proprietary Chinese Medicines in Hong Kong and Canada. We compared registration requirements for Proprietary Chinese Medicine in Hong Kong and Canada based on publicly available information provided by the respective Regulators. A marketed product, Zhizhu Kuanzhong Capsule (SFDA approval number Z20020003; NPN approval number 80104354), was used as a case study to demonstrate the similarities and differences of the requirements in both Hong Kong and Canada. There were similarities and differences between the two regulatory systems in terms of the quality, safety and efficacy requirements. Despite the superficial appearance of similar categories and groups/classes, Hong Kong requires significantly more primary test data compared to Canada's reliance on attestation to manufacturing according the standards outlined in approved reference pharmacopeias/texts. Improved understand of the similarity and differences will enable applicants to plan appropriate strategies for gaining product approval. Exploring ways to harmonize the regulatory process has the potential to benefit manufacturers, regulators, and patients by increasing efficiency and decreasing costs.
中药在传统药物中扮演着标志性角色。由于中药产品在全球广泛使用，中药产品的监管规定常被用作高效监管安全、优质天然产品的典范。我们旨在比较香港和加拿大中成药的监管注册要求。我们根据各自监管机构提供的公开信息，比较了香港和加拿大中成药的注册要求。选用一种市售产品——枳术宽中胶囊（国家食品药品监督管理总局批准文号Z20020003；天然药物产品编号80104354）作为案例研究，以说明香港和加拿大要求的异同。在质量、安全和有效性要求方面，这两种监管体系既有相似之处，也有不同之处。尽管在类别和群组/分类上表面相似，但与加拿大依赖按照批准的参考药典/文本中概述的标准进行生产认证相比，香港要求的原始测试数据要多得多。更好地理解异同将使申请人能够制定适当的策略以获得产品批准。探索协调监管程序的方法有可能通过提高效率和降低成本，使制造商、监管机构和患者都受益。
