Novel coronavirus pneumonia is needed to accelerate the review and approval. What are the following laws and regulations?

It is understood that the special approval procedure for drugs promulgated by Decree No 21 of the Bureau in 2005 is the most comprehensive regulatory document that can still be relied on so far for the registration and approval of prevention and control drugs for public health emergencies In the 2001 Version of drug administration law, there is no special provision for drug registration procedures urgently needed for major infectious diseases and other public health events The regulations for the implementation of the drug administration law issued and implemented in the following year also failed to make corresponding provisions Only in the measures for the administration of drug registration (for Trial Implementation) issued and implemented in 2002, "new Chinese herbal medicines and their preparations, effective ingredients and their preparations extracted from Chinese herbal medicines or natural medicines", "chemical APIs and their preparations, biological products not approved for listing at home and abroad", "AIDS resistance" The rapid approval of four kinds of new drug applications, such as HIV and new drugs for diagnosis and prevention of AIDS, new drugs for treatment of malignant tumors and rare diseases, and new drugs for treatment of diseases without effective treatment means, has made principles, but the specific procedures are not clear In the spring of 2003, the "SARS" epidemic swept across China, and also put forward a test to the emergency system of drug registration management At that time, the State Food and Drug Administration quickly issued the emergency notice on strengthening the supervision and management of drugs and medical devices for the prevention, diagnosis and treatment of SARS, proposing to establish a fast channel for drug approval In this notice, "in accordance with the principle of" no reduction in order, no acceleration, no reduction in standards, and no improvement in assistance ", when the procedures of review, quality review, and review of this kind of drugs are strictly enforced, the measures of" follow-up to review "and" Leniency in and strictness out "shall be implemented The approval of drugs that have been listed abroad or recommended by the World Health Organization (who) may be exempted from clinical trials; the import of drugs for the treatment of SARS shall also be issued with the import drug registration certificate as soon as possible in accordance with the above principles; the urgent import of drugs for the treatment of SARS that have not been registered in China shall be accelerated in accordance with the procedures " The basic technical requirements for the study of drugs for the prevention and treatment of SARS was issued later to further guide and standardize the research and development of such drugs According to the notice, the applicant shall first apply to the scientific and technological research team of the national command for SARS prevention and control, and submit the main research materials, which shall be immediately examined and approved by experts organized by the drug research team The project determined by the drug research working group shall conform to the basic technical requirements for drug research on the prevention and treatment of SARS issued by the drug registration department of the State Food and drug administration Only those varieties that meet the above conditions can enter the fast track for approval For the varieties entering the fast track, the formal review, original data review and on-site assessment of the provincial drug administration shall also be handled as soon as possible So far, the emergency drug approval system for public health emergencies has been initially established Establish special approval procedures for drugs needed for emergency treatment of public health emergencies In 2005, when the measures for the administration of drug registration was revised, based on the practical operation experience of the rapid drug approval channel during the period of "SARS", the "drugs necessary for emergency response" was added on the basis of the four rapid drug applications mentioned above, and the previous normative documents were upgraded to departmental rules and regulations However, there is still no operational procedure in the measures The procedure followed In November 2005, the State Food and Drug Administration issued the special approval procedure for drugs (Order No 21) Decree 21 of the State Food and Drug Administration determined that in case of the threat of public health emergencies and after the occurrence of public health emergencies, in order to obtain the approval of the prevention and control drugs needed for public health emergencies as soon as possible, the State Food and drug administration shall, in accordance with the principles of unified command, early intervention, fast, efficient and scientific approval, carry out the treatment of the drugs needed for public health emergencies Special approval procedures and requirements It is understood that the special approval procedure for drugs promulgated by Decree No 21 of the Bureau in 2005 is the most comprehensive regulatory document that can still be relied on so far for the registration and approval of prevention and control drugs for public health emergencies Time flies to 2019 In the revision of the drug administration law, two provisions have been added to regulate the rapid review and approval of urgently needed drugs in public health They are respectively: "Article 26 for the treatment of serious life-threatening diseases and urgently needed drugs in public health, if the data of drug clinical trials have shown the efficacy and can predict its clinical value, conditional approval may be attached, and relevant matters shall be stated in the drug registration certificate." "Article 96 the State encourages the research, development and production of drugs in short supply, and gives priority to the examination and approval of new drugs that are urgently needed in clinical practice for the prevention and control of major infectious diseases, rare diseases and other diseases." Accordingly, in the latest draft of the measures for the administration of drug registration issued in September 2019, a chapter "accelerating the registration of drugs on the market" is specially added Let's read the special approval procedures in Section 4: Article 1 in case of the threat of public health emergencies and after the occurrence of public health emergencies, the State Administration may, in accordance with the law, decide to implement special examination and approval for the prevention and control drugs needed for public health emergencies Article 2 (special examination and approval Policy) for drug registration applications subject to special examination and approval, the State Administration shall, in accordance with the principles of unified command, early intervention, rapid and efficient, scientific examination and approval, speed up and simultaneously carry out the acceptance, review, inspection and inspection of drug registration The situation, procedures, time limit and requirements of special examination and approval shall be implemented in accordance with the provisions of special examination and approval procedures for drugs Article 3 (requirements of special procedures) drugs included in the special examination and approval procedures may be required to be used within a certain period and scope according to the specific needs of disease prevention and control Article 4 if it is found that a drug included in the special examination and approval procedure no longer meets the conditions for inclusion, the special examination and approval procedure for the drug shall be terminated and the applicant shall be informed The latest draft of the measures for the administration of drug registration is still in the process of soliciting opinions and has not been formally implemented.