Exporting Chinese medicines to Japan: Precautions and risk assessment

I. Regulations and registration requirements
Japanese pharmaceutical regulatory system
PMDA (Pharmaceuticals and Medical Devices Agency): Japan’s comprehensive pharmaceutical and medical device management agency
MHLW (Ministry of Health, Labour and Welfare): Ministry of Health, Labour and Welfare, responsible for final approval
Registration requirements
Application for marketing authorization (NDA): must be submitted through a local Japanese agent
GMP certification: Chinese manufacturers must pass Japan’s GMP inspection
Clinical trial data: usually needs to be conducted in Japan or supplemented with Asian population data
Document requirements: All documents must be provided in Japanese
II. Main precautions

1. Classification management
   Prescription drugs: strictly controlled, requiring full registration
   OTC drugs: relatively simplified but still requiring registration
   Traditional Chinese medicine: managed as “Kampo medicine” and requiring special approval
2. Labels and instructions
   Must be in Japanese
   Content format must comply with the requirements of Japan’s Pharmaceutical Affairs Law
   Specific warnings and instructions for use must be included
3. Quality control
   Comply with Japanese Pharmacopoeia standards (JP)

Stability testing must comply with Japanese climatic conditions

Standards such as microbial limits may be different from those in China

4. Intellectual property
   Pay attention to the patent linkage system

Patent search is required to avoid infringement

III. Risk assessment

1. Regulatory risk
   Long approval cycle: usually takes 4-7 years

Strict requirements: high rejection rate, especially for Chinese medicine products

Policy changes: Japanese pharmaceutical regulations are frequently updated

2. Market risk
   Fierce competition: local pharmaceutical companies dominate

Price pressure: Japan’s medical insurance pricing system is complex

Cultural differences: limited acceptance of Chinese medicine

3. Operational risk
   Supply chain risk: strict cold chain requirements and high transportation costs

Recall risk: Japan has strict supervision of adverse drug reactions

Language barrier: all communications require professional Japanese support

4. Compliance risks
   Advertising restrictions: Promotional activities are strictly regulated

Adverse reaction reporting: A rapid reporting mechanism needs to be established

Traceability requirements: A complete product traceability system is required

IV. Response strategies
Cooperate with local partners: Find experienced Japanese distributors or registered agents

Plan ahead: Reserve sufficient time and budget for registration and approval

Differentiation strategy: Highlight the unique advantages of products and avoid direct competition

Quality first: Invest in production facilities that meet JP standards

Professional team: Establish a regulatory and business team familiar with the Japanese market

V. Special tips
Pay special attention to ingredient restrictions (such as endangered species ingredients) when exporting Chinese medicine

Biological products and special preparations have stricter requirements

Consider a small-scale trial through cross-border e-commerce before applying for formal registration

Although the threshold for exporting drugs to the Japanese market is high and the cycle is long, once successfully entered, the returns are relatively considerable. It is recommended that companies conduct a comprehensive feasibility analysis and risk assessment before making decisions.