1, new drug certificate, 2, drug registration approval (valid for 5 years, after the validity period, re-registration acceptance notice or re-registration approval must be attached), 3, drug registration approval attachments (quality standards, instructions, drug packaging). The certification documents actually include the manufacturer's certification documents: 1, business license, 2, drug production license, and 3, GMP certificate of the dosage form to which the drug belongs.

People's Republic of China (PRC) Drug Administration Law

Article 7 Anyone engaged in the research and development, production, marketing and use of drugs shall abide by laws, regulations, rules, standards and norms, and ensure the truthfulness, accuracy, completeness and traceability of information in the whole process.

Article 8 The drug supervision and administration department of the State Council is in charge of drug supervision and administration throughout the country. The relevant departments of the State Council are responsible for drug supervision and administration within their respective functions and duties. The drug supervision and administration department of the State Council cooperates with the relevant departments of the State Council to implement the national drug industry development plan and industrial policy.

The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the pharmaceutical supervisory and administrative work within their respective administrative areas. The departments responsible for drug supervision and administration of the people's governments at the city or county level divided into districts (hereinafter referred to as drug supervision and administration departments) shall be responsible for drug supervision and administration within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for drug supervision and administration within the scope of their respective duties.

Article 9 The local people's governments at or above the county level shall be responsible for the drug supervision and administration within their respective administrative areas, uniformly lead, organize and coordinate the drug supervision and administration and the response to drug safety emergencies within their respective administrative areas, and establish and improve the working mechanism of drug supervision and administration and the information sharing mechanism.

Article 10 The people's governments at or above the county level shall incorporate the drug safety work into the national economic and social development plan at the corresponding level, incorporate the drug safety work funds into the fiscal budget of the government at the corresponding level, strengthen the capacity building of drug supervision and management, and provide guarantee for the drug safety work.

Eleventh pharmaceutical professional and technical institutions established or designated by the pharmaceutical supervisory and administrative departments shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of pharmaceutical supervision and administration according to law.

Article 12 The State shall establish and improve the drug traceability system. The drug supervision and administration department of the State Council shall formulate unified standards and norms for drug traceability, promote the mutual sharing of drug traceability information, and realize drug traceability.