Chapter 1 General Provisions Article 1 is to regulate the State Food and Drug Administration’s administrative licensing, administrative penalties, administrative legislation, administrative decision-making and other administrative actions, and to protect the legitimate rights and interests of citizens, legal persons and other organizations, according to "Administrative Licensing Law of the People's Republic of China", "Administrative Punishment Law of the People's Republic of China", "Legislation of the People's Republic of China", "Regulations on the Procedure for Formulation of Administrative Regulations", "Procedure for the Formulation of Rules" These rules are formulated in accordance with the provisions of the Regulations. Article 2 Hearings as mentioned in these rules include hearings organized by the State Food and Drug Administration upon application by parties and interested parties and hearings organized ex officio.

These rules shall apply when the State Food and Drug Administration organizes hearings in the process of administrative licensing, administrative penalties, administrative legislation, administrative decision-making, etc. Article 3 Hearings shall follow the principles of openness, fairness, convenience and efficiency.

Except when state secrets, commercial secrets or personal privacy are involved, hearings are held in public. Article 4 Hearings based on application shall be organized and implemented by the legal affairs department, hearings based on ex officio shall be organized and implemented by the undertaking department, and other relevant departments shall be responsible for the related work of hearings in accordance with the provisions of these rules. Article 5 The hearing shall be presided over by the hearing host. When necessary, a hearing officer may be appointed to assist the hearing host. Hearings are recorded by a recorder.

The hearing moderator shall be a person at or above the director level of the hearing organization department. In administrative licensing and administrative penalty hearings, the hearing moderator, hearing officer, and recorder shall be persons who have not participated in the review of this administrative license or the investigation of this administrative penalty case.

The hearing moderator and hearing officer shall be proposed by the legal department or the undertaking department and submitted to the director in charge or the director for decision. The recorder shall be designated by the hearing moderator. Article 6 Hearing moderators, hearing examiners, and recorders shall perform their duties fairly, ensure that hearing participants exercise their rights to make statements, pleas, and cross-examinations, and have the obligation to keep state secrets, commercial secrets, and personal privacy involved in the hearing confidential. Article 7 Hearing participants include personnel of the department responsible for the hearing matter, parties, interested parties, hearing representatives, appraisers, witnesses, translators, etc.

Parties and interested parties may entrust one or two agents to attend the hearing. If an agent is entrusted to participate in the hearing, a power of attorney signed or sealed by the parties and interested parties shall be submitted to the hearing host one day before the hearing. Article 8 The parties and interested parties shall enjoy the following rights during the hearing:

(1) Know the facts, evidence and legal basis for the proposed administrative action;

(2) Apply for a hearing Recusal of personnel;

(3) State claims and reasons, and present evidence;

(4) Conduct defense and cross-examination;

(5) Enjoy rights in accordance with the law Other Rights.

Hearing representatives have the following rights during the hearing:

(1) Express opinions on the content of the hearing;

(2) Conduct inquiries. Article 9 Hearing participants shall attend the hearing on time, obey the instructions of the hearing host, and abide by the hearing discipline. Chapter 2 Pursuant to Article 10 of Application for Hearing, if one of the following circumstances occurs, the handling department shall inform the parties of their right to request a hearing before making a decision: (1) Making an administrative penalty decision ordering the suspension of production and business operations ;

(2) Making an administrative penalty decision to revoke a license or revoking an approval document;

(3) Making an administrative penalty decision to impose a relatively large fine;

< p> (4) Making other administrative licensing decisions that require a hearing upon application as stipulated in laws, regulations, and rules.

If it falls under the circumstances of item (4) of the preceding paragraph, the interested parties shall be notified of their right to request a hearing at the same time. The specific content of the hearing notice in Article 11 is as follows:

(1) Facts, evidence and legal basis for the proposed administrative action;

(2) The right to request a hearing ;

(3) Legal deadlines and channels for requesting a hearing.

The hearing notice shall be made in the form of a hearing notice. Article 12 If an administrative license applicant or interested party requests a hearing, he or she shall apply for a hearing (Attachment 3) to the undertaking department within 5 days from the date of delivery of the hearing notice (Attachment 1). If the administrative penalty party requires If a hearing is to be held, an application for a hearing (Attachment 3) should be made to the undertaking department within 3 days from the date of delivery of the Hearing Notice (Attachment 2).

If the parties or interested parties submit a hearing application within the above time limit, the hearing procedure shall be initiated. The handling department shall notify the legal department within 2 days of receiving the hearing application and hand over all case files. Article 13 The legal affairs department shall organize a hearing within 20 days from the date of receipt of the hearing application from the parties and interested parties, and serve the hearing notice (Attachment 4 and Attachment 5) 7 days before the hearing. The hearing notice shall be It should include the following contents:

(1) Reason for hearing;

(2) Time and place of hearing;

(3) Parties and interested parties Name;

(4) Names and positions of the hearing host, hearing officer, and recorder;

(5) Time limit and channels for filing a recusal application;

(6) Rights and obligations during the hearing;

(7) Other matters requiring notification.

Article 14 If the hearing moderator, hearing officer, or recorder has any of the following circumstances, he or she shall withdraw, and the parties or interested parties may also apply for withdrawal:

(1) Participate in the review or review of this administrative license Investigation of this administrative penalty case;

(2) Being a party, interested party, or a close relative of a party, interested party, or agent;

(3) Being with the party , interested parties or entrusted agents have other relationships that may affect the fairness of the hearing.