The drugs listed in China shall be approved by the drug supervision and administration department of the State Council and obtain the drug registration certificate; However, Chinese herbal medicines and Chinese herbal pieces that are not subject to examination and approval management are excluded.

According to Chapter II Drug Development and Registration of the Drug Administration Law of the People's Republic of China

The drugs listed in China shall be approved by the drug supervision and administration department of the State Council and obtain the drug registration certificate; However, Chinese herbal medicines and Chinese herbal pieces that are not subject to examination and approval management are excluded. The catalogue of varieties of Chinese herbal medicines and Chinese herbal pieces subject to examination and approval management shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent department of traditional Chinese medicine of the State Council.

when applying for drug registration, you should provide true, sufficient and reliable data, materials and samples to prove the safety, effectiveness and quality control of drugs.

Article 25 The pharmaceutical supervisory and administrative department of the State Council shall organize pharmaceutical, medical and other technical personnel to review the drugs applied for registration, and review the safety, effectiveness and quality controllability of the drugs, as well as the applicant's abilities in quality management, risk prevention and control and liability compensation; If it meets the requirements, a drug registration certificate will be issued.

when examining and approving drugs, the drug supervision and administration department of the State Council will review and approve the chemical raw materials, the related auxiliary materials, the packaging materials and containers that directly contact with drugs, and the quality standards, production technology, labels and instructions of drugs.

excipients mentioned in this law refer to excipients and additives used in the production of drugs and the preparation of prescriptions.

article 26 for the treatment of diseases that are seriously life-threatening and for which there is no effective treatment, as well as drugs that are urgently needed in public health, if the clinical trial data of drugs show the curative effect and can predict their clinical value, conditional approval may be granted, and relevant matters shall be stated in the drug registration certificate.

article 27 the drug supervision and administration department of the State Council should improve the system of drug review and approval, strengthen capacity building, establish and improve mechanisms such as communication and expert consultation, optimize the process of review and approval, and improve the efficiency of review and approval.

the evaluation conclusions and basis of drugs approved for marketing shall be made public according to law and subject to social supervision. The business secrets known in the examination and approval shall be kept confidential.

article 28 drugs shall meet the national drug standards. If the drug quality standard approved by the drug supervision and administration department of the State Council is higher than the national drug standard, it shall be implemented in accordance with the approved drug quality standard; If there is no national drug standard, it shall conform to the approved drug quality standard.

The Pharmacopoeia of the People's Republic of China and the drug standards promulgated by the State Council Drug Administration are national drug standards.

The drug supervision and administration department of the State Council, together with the health authorities of the State Council, organized a Pharmacopoeia Committee to be responsible for the formulation and revision of national drug standards.

The drug inspection agency set up or designated by the drug supervision and administration department of the State Council is responsible for calibrating the national drug standards and reference substances.

article 29 the names of drugs listed in the national drug standards are generic names of drugs. If it has been used as a generic name of a drug, the name shall not be used as a drug trademark.