"A bustling Chinese pharmacy with shelves overflowing with colorful medications, a pharmacist in a white coat consulting with a patient, and a modern pharmaceutical factory in the background."

China is biggest market in Asia, no one can ignore it, thus, IUSEA also support to enter China market, IUSEA China Consultancy to share below policy for reference.
Opportunities for Market Access in the Chinese Pharmaceutical Market
I. Drug Registration System
For general drug registration, clinical trial and registration requirements must be met. Before a drug can be marketed in China, it must undergo registration and approval by the National Medical Products Administration (NMPA). The registration process includes new drug applications, generic drug applications, etc., and requires the submission of non-clinical research data (such as pharmacology and toxicology) and clinical trial data to prove the safety and efficacy of the drug.
Priority Review Policy: Critically needed drugs in short supply, innovative and improved new drugs for the prevention of major infectious diseases and rare diseases in China, new varieties of children's drugs, new models and specifications, drugs included in breakthrough therapies, and drugs eligible for conditional approval can be included in the priority review catalog. The review time is 130 days, among which the technical review of rare disease drugs that have been marketed overseas but not in China is completed within 70 days.
II. China Pilot Programs
Boao: For products already marketed in advanced countries such as Europe, the United States, and Japan, companies can apply for pilot import in Boao, and patients can go to Boao for diagnosis and treatment with these drugs. Companies can use Real-World Evidence (RWE) data to assist in registration.
Greater Bay Area: For drugs or medical devices already marketed in Hong Kong and Macau, companies can apply for pilot import in the Greater Bay Area (Guangdong), and patients can go to designated hospitals in the Greater Bay Area for diagnosis and treatment.
Rare disease drugs can be applied for pilot registration in Tianzhu, Beijing (through hospitals such as Peking Union Medical College Hospital, Beijing Children's Hospital, Peking University First Hospital, etc.). Patients can receive diagnosis and treatment with the drug in designated hospitals after approval.