The pharmaceutical sector is one of the highly regulated sectors globally. The industry directly deals with human lives, making it even more crucial and sensitive. Therefore, every country has its own rules and regulations to protect the health of its citizens. National governing bodies establish national Health Authorities (HA) indigenous to that country for quality assurance and regulation of drugs.
At present, China’s Regulatory authority is National Medical Products Administration (NMPA). But NMPA has a significant history.
China’s first Health Authority formed in 1998 was SFDA (State Food and Drug Administration), founded based on State Drug Administration. SFDA majorly regulated food items, cosmetics, and drugs. It was under the legislation of the State Council.
Later in 2013, restructuring and rebranding of SFDA were done, leading to the formation of the China Food and Drug Administration (CFDA). CFDA was a ministerial-level agency that supervised food, drugs, medical devices, cosmetics, and health food.
In 2018, CFDA was reorganized and renamed National Medical Products Administration (NMPA). NMPA comes under the legislation of the State Administration. National Medical Products Administration or NMPA focuses on drafting laws and regulations for drugs, medical devices, and cosmetics.
National Medical Products Administration (NMPA) has stringent requirements for a drug to register in China. Along with this, the procedure is lengthy and slow.
However, we can help you overcome the drug registration challenges in China. If you are experiencing a tough time juggling the terminology and challenges, visit