Mainland China presents potential business prospects for local Hong Kong companies specializing in traditional Chinese medicine, according to the Hong Kong Trade Development Council (HKTDC).
In a significant development for the pharmaceutical industry, Hong Kong firms selling oral traditional Chinese medicines (PCM) across the border to mainland China now face a more streamlined approval process. This change, according to recent reports, is due to the adoption of simplified approval criteria by mainland China for Hong Kong-registered PCMs.
The core technical standards and regulatory requirements that Hong Kong firms must comply with are as follows:
- Good Manufacturing Practice (GMP) Compliance: Oral PCM products must adhere to GMP standards in their production processes. This is a fundamental prerequisite for eligibility under the simplified mainland approval process.
- Historical Usage Requirement: PCM products must have been sold in Hong Kong for more than 15 years. This condition is part of the simplified approval criteria recently adopted by mainland China for Hong Kong-registered PCMs.
- Formal Registration: With Hong Kong's completion of a transitional registration process for PCMs in 2025, all PCMs sold in Hong Kong are now formally registered. This unified registration aids in mainland approval and provides strengthened quality control assurance.
- Compliance with Mainland’s Registration and Quality Control: The streamlined approval procedures by China's National Medical Products Administration impose technical standards aligned with ensuring product quality and safety comparable to mainland requirements.
These criteria allow a more convenient route for Hong Kong firms to gain approval for mainland China sales under the newly simplified process. However, it is important to note that while these steps have been taken to streamline the process, pharmaceutical approvals remain complex and involve regulatory hurdles beyond technical standards alone. As stated, approvals "do not happen overnight."
Interestingly, ninety-three percent of PCM exports were locally produced, and over seventy percent of these exports were sent to mainland China. Last year, PCM products generated HK$2.88 billion (US$367 million) in exports.
Before the recent simplified rules, the process for Hong Kong firms to enter the mainland market was complex due to different technical standards. Now, with the new regulations in place, the path to the mainland market has become smoother, opening up new opportunities for Hong Kong firms in the traditional Chinese medicine industry.
References:
- [Source 1]
- [Source 2]
- [Source 3]
- [Source 4]
- The traditional Chinese medicine (TCM) industry in Hong Kong has witnessed a shift, as the simplified approval process for TCM products in mainland China now includes criteria such as Good Manufacturing Practice (GMP) compliance and historical usage requirement.
- The Health-and-Wellness industry, comprising TCM exporters, may find the recent simplification of the mainland approval process beneficial, as it provides a smoother path to the mainland market and potentially increases business opportunities.
- In the pharmaceutical industry, the TCM products, thanks to their compliance with Mainland’s registration and quality control, can leverage simplified approval procedures established by China's National Medical Products Administration.
- As more Hong Kong TCM firms turn to trade with mainland China, the TCM industry may partially rely on supplements from finance and nutrition sectors to meet the growing demand for TCM products, ultimately impacting the overall health-and-wellness industry.
.){kind=link}