Measures for the Administration of the Expert Advisory Committee on Drug Registration Review were promulgated!

On March 9, the State Administration of Food and Drug Administration announced the Measures for the Management of the Expert Advisory Committee on Drug Registration Review (Trial) (hereinafter referred to as the "Management Measures"), established a consulting system for drug registration review experts, and established an expert advisory committee for drug registration review (hereinafter referred to as the Expert Advisory Committee) to provide technical support and decision-making recommendations for drug registration review. Members of the Expert Advisory Committee are appointed by combining personal referrals with invitations from the Drug Review Centre.1. Dynamic adjustment of members
The Measures refer to the four-year term of office of the members of the Expert Advisory Committee, who may be reappointed after the end of their term of office, in principle, not more than twice in a row; The age of appointment is generally not more than 65 years of age. Except for members of the Advisory Committee of Experts on Major Reform and Development Decisions in Drug Review and experts in special areas and professions. It consists of 12 general expert advisory committees, 10 expert advisory committees in the field of Chinese medicine treatment and 16 expert advisory committees in the field of chemical and biological treatment.
the role of the Expert Advisory Committee, in addition to providing daily advice, technical guidance, decision-making advice, but also to make public arguments on topics of major controversy, to provide professional and technical advice or technical decision-making advice.2 and 3 ways of working
the working methods of the Expert Advisory Committee are divided into daily consultations, expert consultations and expert public demonstration meetings.
, daily consultation. After discussion by the review team of the Drug Review Centre and the review department, the reviewers may raise the technical issues of the review to the members of the Expert Advisory Committee by e-mail, in writing and so on.
Expert consultation requires that if the review department or review team of the Drug Review Centre needs to convene an expert consultation, it shall submit the topics, documents and relevant content background information for the study and discussion of the meeting;
Where the Drug Review Center needs to convene a public demonstration meeting, the Office of the Expert Advisory Committee shall be responsible for preparing and organizing the opinions of the members of the Expert Advisory Committee in the relevant fields on the issue of public argumentation, and the list of members of the expert advisory committee to participate in the public demonstration meeting shall be determined according to other professional and legal, economic and social fields involved in the argumentation, and the number of members of the expert advisory committee shall be singative;Three interests need to avoid
members have the right to supervise the expert consultation work of the Drug Audit Center, directly to the General Administration of Food and Drug Administration to reflect the situation, put forward comments and suggestions, in the participation of the Drug Review Center organization of daily consultation and various types of expert consultation, public demonstration meetings to independently state personal opinions, independent voting, without interference from any units and individuals, at the same time, each year must also accept the annual work assessment and assessment of the Office of the Expert Advisory Committee.
In terms of obligations, special attention should be paid to the fact that the members of the Expert Advisory Committee shall, as participants in the development of the varieties under review, guides or employees of the applicant's unit or participate in the research and development of the competitive varieties under review, take the initiative to state to the Office of the Expert Advisory Committee and avoid them in the review. Members of the Advisory Committee of Experts who have any other interest in the reporting units and individuals of the species under review, as well as other circumstances that may affect the scientific and impartial review, should also recuse them from the review. (Medical Economics)