According to the second chapter of the Drug Administration Law of People's Republic of China (PRC), drug development and registration
Twenty-fourth drugs listed in China shall be approved by the drug supervision and administration department of the State Council and obtain the Drug Registration Certificate; Except for Chinese herbal medicines and Chinese herbal pieces that are not subject to examination and approval management. 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.
To apply for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of drugs.
Article 25 The drug supervision and administration department of the State Council shall organize technicians such as pharmacy and medicine to evaluate the drugs applied for registration, and evaluate the safety, effectiveness, quality controllability of the drugs and the applicant's abilities in quality management, risk prevention and control, liability compensation, etc. If it meets the requirements, a drug registration certificate will be issued.
The State Council pharmaceutical supervisory and administrative department shall, when examining and approving drugs, examine and approve the chemical raw materials together, the relevant auxiliary materials, packaging materials and containers in direct contact with drugs together, and the quality standards, production technology, labels and instructions of drugs together.
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 there is no effective treatment method, and drugs that are urgently needed by 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.
Twenty-seventh drug supervision and management departments in the State Council should improve the drug review and approval system, strengthen capacity building, establish and improve communication and expert consultation mechanisms, optimize the review and approval process, 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. Business secrets known during the examination and approval shall be kept confidential.
Article 28 Drugs must 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 People's Republic of China (PRC) and the drug standards promulgated by the drug supervision and administration department of the State Council are the national drug standards.
The drug supervision and administration department of the State Council shall, jointly with the health authorities of the State Council, organize the Pharmacopoeia Committee to be responsible for the formulation and revision of national drug standards.
The drug inspection institutions set up or designated by the drug supervision and administration department of the State Council are 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.