Approval Process Simplified for Chinese Medicine in Hong Kong & Macao - Draft for Comment

China’s National Medical Products Administration (NMPA) has issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines already marketed in Hong Kong and Macao.The policy is part of broader efforts to integrate the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) and support the growth of the traditional Chinese medicine (TCM) industry, while ensuring product safety, quality, and regulatory compliance.

New Policy for Chinese Medicine in Hong Kong and Macao

The draft policy, titled “Announcement on Simplifying the Mainland Registration and Approval of Traditional Oral Chinese Patent Medicines Already Marketed in Hong Kong and Macao”, targets products that fulfill specific requirements, including:

1. Registration and ownership by locally based manufacturers in Hong Kong or Macao;
2. Approval for sale and usage in their respective markets for over 15 years; and
3. Production in compliance with Good Manufacturing Practice (GMP) standards.

Key Highlights of the Draft Policy

1. Streamlined Application Process Holders of eligible TCM products must appoint a mainland-based legal entity to manage the registration process. The draft policy allows applicants to leverage existing registration data submitted to regulators in Hong Kong and Macao. This includes clinical and non-clinical safety data and a 15-year human usage experience summary, significantly reducing data submission burdens.
2. Accelerated Review Timelines To facilitate faster market entry, the NMPA has shortened the technical review period to 80 working days, down from the standard 200-day timeframe. Products that demonstrate a favorable benefit-risk profile will receive conditional approval. However, marketing authorization holders must complete post-marketing studies to validate safety and efficacy before the next re-registration cycle.
3. Post-Marketing Obligations Once approved, manufacturers are required to implement comprehensive pharmacovigilance practices to monitor product safety and ensure compliance with post-marketing obligations. Local regulatory authorities will oversee adherence to quality standards through inspections and ongoing monitoring.
4. Collaborative Regulatory Oversight The draft policy capitalizes on the strengths of the Greater Bay Area regulatory network. The NMPA’s Drug Evaluation Center, with support from its Greater Bay Area Sub-center, will manage the technical reviews, while the Guangdong Provincial Medical Products Administration will oversee product testing and GMP compliance checks.

Implications for the Traditional Chinese Medicine Industry

This initiative marks a significant advancement in harmonizing regulatory processes across the GBA and fostering cross-regional collaboration.By simplifying registration and reducing review times, the policy enables manufacturers of trusted Hong Kong and Macao TCM products to access the mainland market more efficiently. For manufacturers and regulatory compliance teams, the policy highlights key priorities:

• Maintaining robust GMP standards,
• Ensuring the availability of long-term human usage data, and
• Preparing for enhanced post-marketing surveillance requirements.

Next Steps for Stakeholders

The NMPA is actively seeking feedback on the draft policy to ensure its alignment with industry needs and regulatory goals. The comment period remains open until December 24, 2024, and stakeholders are encouraged to submit their feedback to zhongyaominzuyaochu@nmpa.gov.cn with the subject line “Feedback on Simplified TCM Registration.”This policy represents a promising step toward greater integration and accessibility for traditional Chinese medicines in the mainland market, reinforcing China’s commitment to supporting TCM development while upholding rigorous safety and quality standards.

Further information

To read the Draft Announcement on Simplifying the Registration and Approval of Traditional Chinese Patent Medicines and Simple Preparations for Listing in the Mainland of Hong Kong and Macao, please click here.

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