Core Reminder: The newly revised Regulations focus on 4 core dimensions for foreign pharmaceutical enterprises: compliance, market access, innovation and liability, with concise and key requirements below.
I. Basic Implementation Information
• Effective Date: May 15, 2026; foreign enterprises must complete full-process compliance adaptation before then.
• Core Principle: Align with international drug regulatory rules, strengthen compliance supervision while supporting the market access of foreign innovative drugs in China.
II. Overseas Production and Import Supervision (Core Concern)
• Overseas Production Requirements: For overseas-produced drugs marketed in China, their production activities must fully comply with China's laws, regulations, GMP and relevant standards, and be subject to supervision and inspection by Chinese regulatory authorities.
• Import Registration Norms: ① Drugs applying for import must have marketing authorization in their country/region of production; those without authorization but confirmed safe, effective and clinically needed by China's NMPA may be approved for import. ② Overseas applicants must designate a Chinese domestic enterprise legal person to handle drug registration matters. ③ Overseas holders shall submit re-registration applications to China's NMPA.
•Recognition of Overseas Research Data: Overseas R&D activities for drug registration purposes must comply with China's relevant regulations; eligible overseas research data can be used for domestic drug registration applications, reducing the registration costs of foreign enterprises in China.
III. Review, Approval and Innovation Incentives (Key Benefits)
•Accelerated Marketing Channels: Four accelerated procedures (Breakthrough Therapy Drug, Conditional Approval, Priority Review and Approval, Special Approval) also apply to foreign innovative drugs, significantly shortening their marketing cycle in China.
•Market Exclusivity Period: ① Up to 2 years for pediatric drugs (new varieties, new dosage forms/specifications, new pediatric indications); ② Up to 7 years for rare disease drugs (with supply guarantee commitment); foreign innovative drugs are entitled to this policy in accordance with the law.
•Data Protection: Up to 6 years of clinical trial data protection for drugs containing new chemical components to prevent improper commercial use, protecting the innovative achievements and intellectual property rights of foreign enterprises.
IV. Marketing Authorization Holder (MAH) Liability (Key Compliance)
• Main Liability: Overseas holders shall fulfill the full-life-cycle main liability in China, establish and improve quality assurance systems and pharmacovigilance systems, appoint full-time quality manager and quality authorized person to independently perform the product release duties.
• Domestic Responsible Person Requirements: The domestic responsible person of an overseas holder shall bear joint liability, have legal qualifications, and perform obligations such as quality management, pharmacovigilance and adverse reaction reporting; violations will result in administrative penalties.
• Change Management: If overseas holders adjust production processes, contracted production enterprises, etc., they must fully assess the impact on drug quality, apply for changes or filing in accordance with China's regulations, and shall not make arbitrary changes.
V. Compliance Operation Boundaries (Prohibitive/Mandatory Requirements)
• Online Sales Compliance: It is prohibited to conduct online drug sales beyond China's regulated scope and issue prescriptions for specially managed drugs through online diagnosis and treatment; foreign enterprises must strictly comply with China's compliance requirements for cross-border sales.
• Human Genetic Resources Management: In international cooperative R&D, it is prohibited to illegally collect, preserve or provide China's human genetic resources to foreign parties; strict approval procedures must be followed.
• Marketing Compliance: Academic promotion and drug advertising must comply with China's Anti-Unfair Competition Law and other regulations; commercial bribery is strictly prohibited and will be severely punished.
VI. Penalties and Liability Investigation (Risk Alert)
• Significantly Increased Illegal Costs: Severe violations such as production/import of counterfeit/substandard drugs, illegal change of production processes and data fraud will be subject to "the strictest penalties" with substantially increased fines.
• Penalties on Individuals: Direct liable persons of overseas enterprises in China (legal representatives, main persons-in-charge, quality directors, etc.) will be held accountable, which may restrict their employment qualifications in China and affect the enterprises' operation in China.
• Cross-border Liability Investigation: Overseas enterprises and relevant persons will be held legally accountable for illegal acts, which may affect drug import authorization and market access qualifications.