According to China's relevant laws and regulations, there are indeed some specific drugs that need to submit special qualifications for the record. Specifically, the following three types of drugs need special qualifications for the record:
1. Narcotic drugs: including morphine, cocaine and other narcotic drugs. According to the "Regulations on the Administration of Narcotic Drugs in People's Republic of China (PRC)", the production, circulation and use of narcotic drugs need special qualification filing.
2. Psychotropic drugs: such as antipsychotics, anxiolytics and antidepressants. According to the Regulations on the Administration of Psychotropic Drugs in People's Republic of China (PRC), the production, circulation and use of psychotropic drugs also need special qualifications for the record.
3. Radioactive drugs: including radionuclides and radioactive agents. According to "Regulations on the Administration of Radioactive Drugs in People's Republic of China (PRC)", the production, circulation and use of radioactive drugs also need special qualifications for the record.
For these drugs, relevant enterprises or individuals need to submit special qualification filing applications to National Medical Products Administration, and meet a series of statutory requirements and standards, including equipment and facilities, personnel qualifications, quality management and other requirements. The production, circulation and use of related drugs can only be legally engaged after obtaining the approval of special qualification for filing.
It should be noted that the above is only a general answer, and the specific requirements may be different due to changes in regions, drug types and regulations. Therefore, in the specific operation, it is recommended to consult professional lawyers or relevant departments to obtain the most accurate information and guidance.
Drug filing refers to the procedure of filing special qualifications of drugs according to the provisions of relevant laws and regulations. According to China's relevant laws and regulations, three drugs need to submit special qualifications for the record. The filing requirements of special qualifications include providing relevant certification materials, production technology and quality control system of drugs. Procedurally, it is necessary to prepare relevant materials first, and then submit an application for filing to the relevant drug regulatory authorities. The regulatory authorities will review the application materials, and if they meet the requirements, they will issue a record certificate. The purpose of filing is to ensure the quality and safety of drugs and protect the public's rights and interests in drug use. Drug filing is an important legal requirement, and drug production enterprises should actively cooperate and go through the filing procedures according to regulations.
Legal basis:
People's Republic of China (PRC) Drug Administration Law (revised on 20 19);
Chapter I General Provisions Article 5 The State encourages the research and creation of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.