Drug registration in China is a complex process that involves several steps and requires compliance with various regulations and guidelines set by the Chinese government. Here are some key points to keep in mind:

Chinese Pharmacopoeia: All drugs registered in China must comply with the requirements of the Chinese Pharmacopoeia.

Applicant: Only a company registered in China can apply for drug registration in the country. However, foreign companies can collaborate with Chinese companies to register their drugs in China.

Drug Classification: Drugs are classified into different categories based on their safety and efficacy. The categories include chemical drugs, traditional Chinese medicines, biologics, and medical devices.

Application Types: There are three types of drug registration applications in China: new drug application (NDA), supplementary new drug application (SNDA), and generic drug application (GDA).

Clinical Trials: Clinical trials conducted in China must follow the Chinese Good Clinical Practice (GCP) guidelines. The data from these trials must be submitted as part of the registration application.

Review Process: The China National Medical Products Administration (NMPA) is responsible for reviewing drug registration applications. The review process can take up to 12 months for an NDA and 8 months for an SNDA.

Post-Market Surveillance: After a drug is registered in China, the NMPA conducts post-market surveillance to monitor the safety and efficacy of the drug.

TOSUN Pharmaceutical has successfully registered more than 200 APIs, excipients, and packaging materials, covering many fields such as cardiovascular and cerebrovascular, oncology, neurology, gastroenterology, and respiratory medicine. The experienced registration team, proficient in the regulatory requirements of registration, can quickly help you obtain drug registration qualifications efficiently and cost-effectively around the world. At the same tim