A Review of China's Life Science and Healthcare Sector 2021: Embracing a Dynamic Regulatory Landscape

Summary

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• The Chinese government has been taking a series of reform initiatives to enhance the affordability of pharmaceutical products, medical devices and healthcare services.
• NMPA released the first Good Pharmacovigilance Practice(GVP) which means that sponsors or market authorization holders (MAH) are required to conduct pharmacovigilance activities throughout the entire lifecycle of a pharmaceutical product.
• Under the Good Pharmacovigilance Practice, pharma companies must proactively monitor and detect all indicators related to drug safety and robustly address and mitigate any identified risks.

China has been rapidly growing into the world's second-largest healthcare market. Over the past decade, the Chinese government has been taking a series of reform initiatives to enhance the affordability of pharmaceutical products, medical devices and healthcare services to patients by restructuring the legal framework in the life science and healthcare sectors, starting with the Law on the Administration of Pharmaceuticals (药品管理法)of 2019 followed by the Regulations for the Regulation of Medical Devices (医疗器械监督管理条例) and the Cosmetics Oversight Regulations (化妆品监督管理条例) of 2021. By the end of 2021, the fundamental laws and regulations in the life science sector have taken shape and been enforced.

The regulatory reforms in the life science sector are undergoing refinement and expansion, and the objectives are how the restructured legal framework will be enriched, developed and implemented. Instead of observing, life sciences companies must take steps to adjust and adapt their business operations to meet the ever-evolving regulatory requirements.