Question 1

What is the Meaning of Chinese Drug Administration Law?

Accepted Answer

The principal legislative act enacted by the People's Republic of China that provides the legal framework for regulating the entire lifecycle of pharmaceutical products, from research and development to manufacturing, distribution, and clinical use. This comprehensive law is primarily enforced by the National Medical Products Administration (NMPA) and is designed to rigorously safeguard the quality, safety, and therapeutic efficacy of all medicines accessible to the Chinese public. Recent revisions have aimed to modernize and align regulatory standards with international best practices for drug approval.

Question 2

What is the Origin of Chinese Drug Administration Law?

Accepted Answer

The law's origin lies in the sovereign authority of the Chinese government to establish a robust system for public health protection and the meticulous regulation of its expansive domestic pharmaceutical sector. Its historical evolution reflects China's increasing engagement with the global drug market and the necessary development of a transparent, scientifically sound regulatory system. The foundational principles are a synthesis of global pharmaceutical regulation adapted to the unique legal and administrative structure of China.

Question 3

What is the Mechanism of Chinese Drug Administration Law?

Accepted Answer

The law operates by establishing mandatory, non-negotiable procedures for drug registration, demanding adherence to rigorous Good Manufacturing Practice (GMP) for production, and mandating detailed clinical trial protocols. It dictates the approval process for new drug applications, establishes comprehensive post-market surveillance requirements, and outlines severe penalties for non-compliance. This regulatory mechanism creates a strict, verifiable system of accountability for all entities involved in the pharmaceutical supply chain.

Chinese Drug Administration Law

Meaning

Origin

Mechanism

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