Drugdu.com expert's response:

When Chinese traditional and Western medicines venture overseas, there are multiple aspects requiring attention, encompassing regulatory compliance, market access, intellectual property protection, and cultural difference management. Below is a detailed analysis:

I. Regulatory and Compliance Aspects

Target Market Regulations: It is essential to gain an in-depth understanding of the drug regulatory regulations in the target country or region, including requirements for registration, approval, clinical trials, and Good Manufacturing Practice (GMP) for production quality management. For example, the U.S. FDA mandates rigorous clinical trials before a drug can be marketed, while the EU EMA emphasizes compliance with GMP standards in the production process. Different countries have specific requirements for drug ingredients, labels, and instructions, necessitating compliance with local regulations.

International Certifications and Standards: Obtaining international certifications (such as WHO prequalification, PIC/S GMP) can enhance product credibility and facilitate market access. Adhering to international quality standards (such as ISO, ICH guidelines) ensures product quality and safety.

II. Market Access and Marketing

Market Research and Positioning: Analyzing target market demand, competitive landscape, payment capabilities, and cultural preferences allows for the development of differentiated strategies. For instance, the European and American markets prioritize efficacy and safety, whereas emerging markets focus more on price accessibility. Assessing local healthcare policies, drug pricing mechanisms, and reimbursement directories enables the formulation of reasonable pricing strategies.

Market Access Pathways: Entering the market through localization registration, licensing agreements, or mergers and acquisitions. For example, BeiGene's PD-1 inhibitor achieved market entry in the United States after FDA approval, demonstrating innovative drug exportation. Establishing a localized team or partnering with local entities to assist in registration, clinical trials, and sales.

III. Intellectual Property and Patent Protection

Patent Layout: Filing patents in target markets in advance protects core technologies and avoids infringement disputes. For example, the ADC drug licensing case between Kelun Pharmaceutical and Merck & Co. highlights the importance of patent layout.

Technology Licensing and Collaboration: Ensuring technology compliance and reducing legal risks through technology licensing and collaborative research and development.

IV. Cultural and Market Differences

Cultural Adaptability: Respecting the target market's culture and adjusting product positioning and marketing strategies accordingly. For example, the exportation of traditional Chinese medicine necessitates consideration of local acceptance of traditional medicine.

Language and Communication: Providing multilingual labels, instructions, and customer support to ensure accurate information dissemination. For instance, entering the U.S. market with traditional Chinese medicine requires providing English prescriptions and drug instructions.

V. Supply Chain and Risk Management

Supply Chain Management: Establishing a stable supply chain to ensure compliance with regulations in raw material procurement, production, and transportation, particularly in cold-chain logistics and quality management.

Risk Response: Assessing political, economic, and legal risks and developing contingency plans. For example, Fosun Pharma achieved full-process traceability in the global supply of COVID-19 vaccines by collaborating with international logistics companies.

VI. Other Key Considerations

Clinical Validation: Some countries require drugs to undergo local clinical trials, necessitating early planning and resource allocation.

Payment and Reimbursement: Understanding the local payment system and healthcare reimbursement policies to design affordable pricing strategies.

Talent Development: Cultivating an international team familiar with the target market to enhance cross-cultural management capabilities.