Order of China Food and Drug Administration No.1

The Administrative Rules of China Food and Drug Administration on Legislative Procedure has been adopted at the China Food and Drug Administration executive meeting on September 27, 2013 and is hereby promulgated and shall take effect as of December 1, 2013.


Director General: Zhang Yong
October 24, 2013

Administrative Rules of China Food and Drug Administration on Legislative Procedure

Chapter I General Provisions

Article 1 In order to standardize the legislative procedure of China Food and Drug Administration (CFDA), guarantee the quality of legislation, and improve legislation efficiency, these administrative rules are specially formulated in accordance with the laws and administrative regulations such as the Legislative Law of the People’s Republic of China, the Regulations on the Procedures for the Formulation of Administrative regulations, the Regulations on the Procedures for the Formulation of Administrative Rules, the Regulations on the Filing of Administrative Regulations and Rules, and the relevant requirements of the State Council.

Article 2 These regulations are applicable to the following legislative activities:
(I)　Compiling the middle and long-term legislative plan and annual legislative plan for the supervision and management of foods and drugs;
(II)　Putting forward the suggestions on the formulation, modification or abolishment of the laws and administrative regulations on the supervision and management of foods and drugs;
(III)　Drafting and submitting the draft laws and administrative regulations on the supervision and management of foods and drugs;
(IV)　Formulating, modifying, abolishing, and interpreting the administrative rules in accordance with the responsibilities of China Food and Drug Administration; and
(V)　Other relevant legislative work.

Article 3 The legislation work of CFDA shall be uniformly managed by the Department of Legal Affairs under the leadership of the director general. All departments and bureaus divide labor with individual responsibility according to their responsibilities:
(I)　Department of Legal Affairs shall be responsible for organizing and coordinating the legislative work, including the compilation, organization and implementation of medium and long-term legislative plan and annual legislative plan, review of the draft for review of legislation draft, and submission to CFDA executive meeting for deliberation and filing; be responsible for organizing the drafting of comprehensive laws and administrative regulations; and be responsible for the examination of the legality of normative documents, etc;
(II)　All departments and bureaus shall be responsible for the legislative work within their respective scope of business, including applications for legislative projects, participation in the compilation of legislative plan, putting forward legislation draft, and soliciting the opinions of relevant departments and units, drafting up the document for examination and instructions, preparing relevant materials for submission, etc.

Article 4 The legislative work of food and drug administration shall abide by the principles of legislation according to law, scientific legislation, and democratic legislation, follow objective laws, insist on reform and innovation, improve administrative efficiency, guarantee the integrity of legal system, and safeguard fairness and justice.

Article 5 Legislative contents shall be detailed but not verbose, logically sound and operable with their articles clear and concrete, and their wording accurate and concise.

Chapter II Approval of Project Proposal

Article 6 Department of Legal Affairs shall organize the feasibility study of projects on formulation of administrative regulations and rules on food and drug supervision and the submission of the proposals for such projects to CFDA in accordance with the legislative plan of the Standing Committee of the National People’s Congress and the State Council.
All departments and bureaus shall, taking into consideration of the demand for food and drug supervision, conduct the feasibility study of projects on formulation of laws, administrative regulations and rules and put forward the proposals for such projects. In case that the comprehensive laws and administrative regulations with the legislative contents involving the responsibilities of a number of departments and bureaus and difficult to determine the major responsible departments and bureaus, the Department of Legal Affairs shall prepare the proposals for such projects.
The proposals for such projects of formulation of laws and administrative regulations shall be reported to the Standing Committee of the National People’s Congress and the State Council in the form of CFDA document according to provisions after being approved by the leader of CFDA.

Article 7 Department of Legal Affairs shall solicit the project proposals for the formulation and modification of the administrative rules for next year from all departments and bureaus in the fourth quarter of each year.
The project proposals for the formulation and modification of the administrative rules from various departments and bureaus shall clearly list out the name of project, legislative necessity and feasibility, main problems to be solved, main system to be established or perfected, relevant work already conducted, project leader, scheduling, and other contents.

Article 8 The matters for formulating administrative rules shall be the matters related to the implementation of laws or the administrative regulations, decisions, and orders of the State Council. In case of the matter involving the functions and powers of more than two departments of the State Council, the formulation of related administrative regulation shall be submitted to the State Council and the formulation of related administrative rules shall be submitted to relevant departments of the State Council.

Article 9 The food and drug administrative departments of provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as the provincial food and drug administrative department) may put forward project proposals for formulation of laws, administrative regulations and rules to CFDA.
Citizens and organizations may put forward project proposals for formulation of laws, administrative regulations and rules on food and drug supervision to CFDA by way of correspondence, messages through the Internet, etc.
After receiving project proposals, Department of Legal Affairs shall submit the project proposals to relevant departments and bureaus that shall study and manage the proposals according to division of responsibilities.

Article 10 The annual legislative plan of laws, administrative regulations and administrative rules drawn up by Department of Legal Affairs for CFDA shall be in consistent with the legislative plans of the Standing Committee of the National People’s Congress and the State Council, and take into account in a systematic way the proposals for the legislative projects raised by all departments and bureaus inside CFDA.

Article 11 Formulating legislative plan shall stress the key points, make overall plans and take all factors into consideration, give full demonstration, and provide prudent options. The project with high social awareness and urgently requiring supervision and management shall be given priority.

Article 12 Annual legislative plan should include such contents as the name of project, drafting department, project leader, schedule, etc. of laws, administrative regulations and rules.
Projects for formulation of administrative rules are divided into two grades. The projects with mature legislative conditions and high possibility of getting promulgated within the year are listed as the first-grade projects; those with immature conditions, requiring prompt research, and promoted to be promulgated at an appropriate time may be listed into the grade-two projects.

Article 13 Legislative plan should be submitted to CFDA executive meeting for deliberation and adoption in the first quarter of each year and distributed in the form of CFDA document to each department or bureau or subordinate unit for execution. A copy shall be made to provincial food and drug administrative department.

Article 14 Legislative plan shall be executed strictly. Department of Legal Affairs shall be responsible for organizing and supervising the execution of the legislative plan, timely grasping the progress of legislative project, and reporting the execution of the annual legislative plan to CFDA executive meeting. The department or bureau undertaking drafting work shall submit the legislation draft for examination according to legislative plan in a timely manner.

Article 15 If it is indeed necessary to adjust legislative project according to the actual work of CFDA, a written application shall be submitted by relevant department and bureau. After being examined by Department of Legal Affairs, it shall be submitted to the CFDA executive meeting for decision.

Chapter III Drafting

Article 16 The laws, administrative regulations and rules included in the annual legislative plan shall be drafted by the department or bureau applies for the project approval; if the application of project approval involves the responsibilities of several departments or bureaus, one department or bureau shall be responsible for the drafting mainly while other relevant departments or bureaus shall provide assistance, and jointly put forward legislation draft. Department of Legal Affairs shall organize the drafting of comprehensive laws and administrative regulations.
Drafting department shall determine a departmental or bureau leader as the responsible person and designate dedicated persons in charge of specific work. Department of Legal Affairs shall designate dedicated persons to provide support actively and participate along the whole course.

Article 17 Drafting department shall conduct in-depth investigation and study, understand administrative history, current status, and existing problems, study domestic and foreign administrative experience, and put forward practical and feasible legislation draft.
In the course of drafting, drafting department shall extensively hear the opinions of relevant departments, relevant units, trade associations, grassroots law-enforcement personnel, and citizens. Seeking opinions may take the form of symposium, seminar, hearing, field investigation and research, online open solicitation for opinions, etc.
Drafting department shall attach instructions for drafting when soliciting opinions from the public for legislation draft.

Article 18 If legislation draft involves significant adjustment of the system and mechanism of food and drug administration and administrative measures or has significant impact on the immediate interests of citizen and the food and drug industry, drafting department shall organize risk assessment on social, economic and other aspects and generate evaluation report as the basis for legislation decision-making.

Article 19 If legislation draft involves the responsibility of other departments or closely relates to other departments, drafting department shall solicit opinions initiatively and reach consensus with relevant department through negotiation.
After adequate negotiation, if relevant units within the system still have differing opinions on the legislation draft, it shall be reported to the competent leader of CFDA for decision; if the relevant department outside the system has differing opinions on the legislation draft and a consensus still cannot be reached after adequate negotiation with the drafting department, the relevant situations and reasons shall be specified when the legislation draft is submitted for examination.

Article 20 Drafting department shall carefully study and adopt the opinions from different aspects, generate draft for examination for the legislation draft, and send instructions for drafting and relevant materials to Department of Legal Affairs for examination after being studied at CFDA executive meeting, and obtaining signed opinions from the director general and consent from the competent leader of CFDA.
Instructions for drafting shall specify the necessity, feasibility, main basis, main system and administrative measures established or improved, opinions from relevant parties and the adoption, and whether the relevant administrative rules and normative documents should be sorted out, etc.
The relevant materials shall include survey reports, domestic and foreign materials relating to legislation, summarized opinions from relevant aspects, records of symposium and discussion meeting, records of hearing, evaluation report, etc.

Chapter IV Review

Article 21 Department of Legal Affairs shall conduct formal examination within 5 working days after receiving the materials submitted by drafting department; for those not complying with the requirements in Article 20 of these regulations, drafting department shall make up relevant materials within 15 days; in case the materials are not made up in time, they will be returned to the drafting department.

Article 22 Department of Legal Affairs shall complete substantive examination within 30 days in principle for those complying with the requirements of formal examination. Substantive examination shall include the following contents:
(I)　Compliance with statutory authority and procedure;
(II)　Compliance with the spirit and principle of the constitution;
(III)　Compliance with the provisions of laws, administrative regulations and other higher-level laws; existence of illegally stipulating administrative license, administrative sanction, and administrative compulsory execution;
(IV)　Whether the opinions of relevant departments, units and citizens are properly handled;
(V)　Rationality and operability;
(VI)　Consistency with the technical requirements of legislation; and
(VII)　Other contents to be examined.

Article 23 Department of Legal Affairs may re-solicit opinions for the main problems involved in the draft for examination. Soliciting opinions may be in the following forms:
(I) Solicit the opinions of provincial food and drug administrative department in writing;
(II) Solicit the opinions of relevant departments, unit and experts in writing;
(III) Conduct field investigation and hear the opinions of relevant grassroots units and individuals;
(IV) Organize and convene symposium, discussion meeting, hearing, etc.

Article 24 Draft for examination shall be submitted to the competent leader of CFDA for examination and approval after being examined and modified by Department of Legal Affairs and becoming mature on the whole. With the approval from the competent leader of CFDA, the draft for examination shall be published on Chinese government legal information website for soliciting opinions and reproducing on the government website of CFDA. The time for soliciting opinions generally shall be no less than 30 days.

Article 25 In the course of examination and modification, Department of Legal Affairs shall adequately communicate with drafting department, comprehensively understand the intent, background, administrative process of drafting and main problems to be solved. Drafting department shall cooperate actively, introduce relevant situations, and provide relevant materials.

Article 26 The draft for examination that meets the requirements of the regulations and reaches consensus with relevant department or bureau after examination and modification shall be submitted to CFDA executive meeting for deliberation after being studied at the executive meeting of Department of Legal Affairs, and obtaining signed opinions from the general director and consent from the competent leader of CFDA.

Article 27 In any of the following circumstances, the draft for examination may be announced again after being studied at the executive meeting of Department of Legal Affairs, returned to drafting department with signed opinions from the director general, and modified and improved by the drafting department:
(I)　The basic conditions for legislation are immature;
(II)　Drafting department has not conducted adequate survey and reasoning on the main system specified;
(III)　There is big dispute among relevant departments about the main system specified and the drafting department has not reached consensus with relevant departments through negotiation; and
(IV)　Other circumstances not complying with requirements.

Chapter V Deliberation and Publication

Article 28 If legislation draft is planned to be submitted to the executive meeting of CFDA for deliberation, the written application shall be put forward by Department of Legal Affairs. The draft of a law or an administrative regulation, the script version for approval and the instructions for drafting of an administrative rule shall be attached. After reporting to the leader of CFDA for consent according to provisions, the legislation draft shall be submitted to the General Office for arranging meeting.

Article 29 When the executive meeting of CFDA reviews the draft of a law or an administrative regulation, the script version for approval of an administrative rule, Department of Legal Affairs shall provide instructions. The main contents of the instructions include legislative background, drafting process, main contents, and important issues to be deliberated, etc. If necessary, drafting department may give supplementary instructions on relevant issues such as legislative evaluation, implementation procedures, etc.

Article 30 After the draft of a law or an administrative regulation, the script version for approval of an administrative rule is discussed and adopted at the executive meeting of CFDA, Department of Legal Affairs shall make modifications according to the deliberation opinions of the executive meeting of CFDA in conjunction with the drafting department.
The draft of a law or an administrative regulation shall be submitted to the State Council after being signed and issued by the director general. The script version for approval of an administrative rule shall be made public after signed order by the director general.
The draft of a law or an administrative regulation, or the script version for approval of an administrative rule that has been deliberated but not adopted at the executive meeting of CFDA may be resubmitted to the executive meeting of CFDA for deliberation after Department of Legal Affairs organizes the drafting department for modification according to requirements.

Article 31 The administrative rules sponsored by CFDA and co-promulgated with other departments of the State Council shall be signed and issued by sending to the department for joint release after being deliberated at the executive meeting of CFDA and signed and issued by the director general.
The administrative rules sponsored by other departments of the State Council and jointly released by CFDA shall be submitted to the director general for signing and issuance after Department of Legal Affairs puts forward examination opinions in conjunction with relevant departments and consent is obtained from the competent department of CFDA.

Article 32 The order of CFDA for promulgating administrative rules shall clearly specify the formulating body of the administrative rules, serial number, name of administrative rules, adopting date of the executive meeting of CFDA, implementation date, signature of the director general, date of promulgation, etc.
The administrative rules jointly promulgated by CFDA in conjunction with other departments of the State Council shall be promulgated after cosigned by the director general and the leader of the joint department and use the serial number of the order of the competent authority.

Article 33 The administrative rules shall take effect 30 days after the date of promulgation; however, if the implementation of the regulations is hindered without immediate implementation after promulgation, the regulations may take effect from the date of promulgation.

Article 34 After administrative rules are signed, Department of Legal Affairs shall distribute the printed text of the administrative rules to each provincial food and drug administrative department and all departments and bureaus and directly affiliated units of CFDA and timely publish the text of the administrative rules and instructions for interpretation on CFDA government website and relevant media.

Chapter VI Filing and Interpretation

Article 35 The administrative rules of CFDA shall be submitted to the State Council for filing by Department of Legal Affairs in accordance with the relevant provisions of the Regulations on the Filing of Laws, Regulations and Administrative Rules within 30 days after the date of promulgation.

Article 36 If the text of the laws and administrative regulations on food and drug administration needs to further define the meaning and boundary, the relevant department and bureau shall put forward request for interpretation. After examination by Department of Legal Affairs and submitting to the leader of CFDA for approval, the text shall be submitted to the Standing Committee of the National People’s Congress and the State Council for interpretation in the form of CFDA document.

Article 37 In any of the following circumstance, CFDA shall be responsible for the interpretation of the clauses of the administrative rules:
(I)　The specific meaning or application scope of clauses of the administrative rules should be further defined;
(II)　The basis for application or scope of application should be made clear when new situation appears after the formulation of the administrative rules.
If the clauses of administrative rules should be interpreted, relevant department or bureau shall put forward the draft of interpretation opinions, which shall be promulgated in the form of CFDA document and made public after being examined by Department of Legal Affairs and submitted to the leader of CFDA for approval.
The interpretation of the clauses of the administrative rules shall have the same legal effect as the administrative rules.

Article 38 The specific application issues involving laws, administrative regulations and rules in the process of law enforcement for food and drug administration, the relevant department or bureau shall put forward draft opinions, which shall be promulgated in the form of CFDA document and made public after being examined by Department of Legal Affairs and submitted to the leader of CFDA for approval.

Chapter VII Evaluation, Sorting and Compilation

Article 39 After administrative rules take effect, Department of Legal Affairs may, in conjunction with relevant departments and bureaus, organize post-legislation evaluation on the social effects of implementation of the administrative rules as necessary.
Evaluation results shall be used as the important reference basis for modifying or abolishing the administrative rules.

Article 40 Post-legislation evaluation may be in the form of questionnaire, field investigation, symposium, reasoning, etc. to extensively hear the opinions from all circles of the society, or be organized and undertaken by socially-committed third party institutions of higher learning, research and consultation institutions, trade associations, etc. under authorization.

Article 41 In addition to the necessary sorting of administrative rules after promulgation of laws and administrative regulations, Department of Legal Affairs shall periodically organize comprehensive sorting of administrative rules of each department or bureau. The results of such sorting shall be made public through CFDA government website.

Article 42 In any of the following circumstances, administrative rules shall be abolished:
(I)　The basis for legislation is lost due to the abolishment or modification of relevant laws and administrative regulations;
(II)　The issues specified have been completely executed or their continued implementation is unnecessary due to the change in actual situations;
(III)　The main contents of the regulations have been substituted by relevant higher-level laws or other administrative rules; and
(IV)　Other circumstances that call for abolishment.
The document for abolishing administrative rules shall, in principle, be made public in the form of CFDA decree.

Article 43 Department of Legal Affairs shall be responsible for periodically compiling the updated food and drug administrative laws, administrative regulations and rules into volumes and distributing them to each provincial food and drug administrative department and all departments and bureaus and all directly affiliated units of CFDA.

Chapter VIII Examination and Sorting of Normative Documents

Article 44 CFDA shall formulate the normative documents with universal binding force upon the rights and obligations of administrative counterparts and applicable repeatedly for the implementation of laws, administrative regulations and rules. The drafting work shall refer to Article 17 through Article 19 of the Regulations.

Article 45 The normative documents drafted by each department or bureau shall be submitted to Department of Legal Affairs for legal review, promulgated in the form of CFDA document according to specified procedures, and made public after being countersigned by Department of Legal Affairs.

Article 46 Department of Legal Affairs shall periodically organize all departments and bureaus to sort normative documents. The results of sorting shall be made public through CFDA government website and compiled into volumes by Department of Legal Affairs and distributed to each provincial food and drug administrative department, and all departments and bureaus and all directly affiliated units of CFDA.

Chapter IX Supplementary Provisions

Article 47 If the application scope of the formulated administrative rules and normative documents covers foreign affairs, a request for instructions shall be submitted to the State of Council before official release in accordance with the requirements of the Notice of the State Council on Further Standardizing the Formulation of Departmental Rules and Normative Documents Involving Foreign Affairs (Document No. 92 [2006]).

Article 48 If the application scope of the administrative rules and normative documents is subject to the relevant rules of the World Trade Organization (WTO) and shall be disclosed to WTO, the drafting department shall obtain consent from the competent leader of CFDA before submitting legislation draft to the Law Department for review and notify according to provisions.

Article 49 Food and drug administration referred in these regulations shall include the supervision and management of food (including health foods), drugs, medical devices, cosmetics, etc.

Article 50 These administrative rules shall take effect as of December 1, 2013; the Administrative Rules of State Food and Drug Administration on Administrative Legislative Procedure promulgated on April 30, 2002 (Order No.33 of the State Food and Drug Administration) will be annulled as of the same date.