环球律师事务所-全球法律指南：生命科学2023之中国篇（英）-30页_941kb

Summary of China Life Sciences 2023 Legal and Regulatory Framework

Introduction

The Global Law Office provides a comprehensive analysis of China's life sciences regulations in the 2023 Chambers Global Practice Guide. This guide covers legislation, clinical trials, marketing authorizations, manufacturing, distribution, import/export rules, pricing, reimbursement, digital healthcare, intellectual property (IP), and COVID-19-related measures. It is authored by experts Alan Zhou, Coco Fan, Stephanie Wang, and Xuchun Huang.

Key Regulatory Framework

• Primary Laws: The Drug Administration Law (DAL) and Regulations for the Supervision and Administration of Medical Devices (RSAMD) form the backbone of pharmaceutical and medical device regulation.
• Regulatory Bodies: National Medical Products Administration (NMPA) handles registration and post-market oversight; State Administration for Market Regulation (SAMR) enforces consumer protection and competition laws; National Healthcare Security Administration (NHSA) manages pricing and reimbursement.
• Challenging Decisions: Administrative review or litigation can challenge regulatory decisions for pharmaceuticals and medical devices.
• Categories: Pharmaceuticals are divided into prescription and over-the-counter (OTC) drugs, while medical devices are classified into Classes I, II, and III based on risk.

Clinical Trials

• Regulation: Governed by Good Clinical Practice (GCP) standards; drugs require NMPA approval before marketing authorizations, while medical devices depend on classification for clinical evaluation or trials.
• Authorization Process: For drugs, clinical trials must be authorized by the NMPA's Center for Drug Evaluation (CDE); medical devices follow risk-based evaluations.
• Data and Privacy: Personal data from trials must comply with the Personal Information Protection Law (PIPL), and human genetic resources are restricted under the Biosecurity Law.

Marketing Authorizations

• Classification: Pharmaceuticals include drugs and biological products; medical devices are Class I, II, or III. MAHs hold responsibility for post-market obligations.
• Procedure: Drugs follow drug registration, re-registration, or supplemental applications; medical devices use registration for higher classes and filing for lower risk.
• Ongoing Obligations: MAHs must maintain pharmacovigilance systems, post-market monitoring, and reporting requirements.

Manufacturing and Distribution

• Authorizations: Pharmaceutical manufacturing requires drug licenses; medical devices need permits based on classification. Third-party access to pending applications is available via NMPA databases.
• Border Measures: Counterfeit goods are addressed through IP protection, including border seizures and customs cooperation under WTO TRIPS Agreement.

Import and Export

• Governing Law: Customs Law and DAL/RSAMD apply. Import requires prior authorizations for most pharmaceuticals and medical devices.
• Non-Tariff Restrictions: Includes quotas and certifications for specific products through trade agreements and local regulations.

Pricing and Reimbursement

• Control: Drug pricing is market-based except for controlled substances; medical device pricing influenced by budget constraints and central procurement.
• Reimbursement: The National Reimbursement Drug List (NRDL) classifies drugs for coverage; medical devices may be reimbursed through healthcare funds with regulatory oversight.

Digital Healthcare

• Apps and Telemedicine: Medical apps with diagnostic functions are regulated as devices; telemedicine is permitted under specific guidelines, promoted during COVID-19.
• Online Sales and Data: Electronic prescriptions and online sales are allowed but regulated; personal data must comply with PIPL and data security laws.

Intellectual Property

• Patents: Life sciences patents face scrutiny on enablement and inventive step; term extensions available for pharmaceuticals. Compulsory licensing applies in public health emergencies or monopolistic practices.
• Other IP: Trade marks are restricted for pharmaceuticals (e.g., generic names cannot be trademarked), and data exclusivity is available for drugs for six years post-approval.

COVID-19 Impact

• Special Regulations: Emergency approvals, conditional approvals, border measures, and liability exemptions were introduced. Digital health innovation, such as telemedicine, was encouraged. Import/export flexibility was granted, with a focus on vaccine and medical device supply.

Conclusion

This guide by Global Law Office offers detailed insights into China's evolving life sciences landscape, emphasizing practical legal services, digital innovation, and pandemic-related flexibilities.