(Source: https://pltfrm.com.cn)
China’s healthcare industry is governed by a set of rigorous compliance requirements aimed at ensuring safety, quality, and ethical practices. Key aspects include:
- Regulatory Standards: The National Medical Products Administration (NMPA) oversees the regulation of pharmaceuticals and medical devices. Companies must adhere to the Good Manufacturing Practice (GMP) standards for drugs and the Good Manufacturing Practice for Medical Devices (GMP-MD). Compliance involves regular inspections and obtaining certifications from the NMPA.
- Clinical Trials: The Regulations for the Administration of Clinical Trials require that clinical trials be conducted following strict ethical guidelines and regulatory requirements. Trials must be approved by the Ethics Committee, and data must be reported transparently to the relevant authorities.
- Data Protection: The Personal Information Protection Law (PIPL) and the Data Security Law (DSL) set forth requirements for the protection of patient data. Healthcare providers and companies must ensure that personal and medical information is handled securely and that patient consent is obtained for data usage.
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