The State Food And Drug Administration Of The Legislative Procedure

Original Language Title: 国家食品药品监督管理总局立法程序规定

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201503/20150300398620.shtml

The State food and drug administration of the legislative procedure

    (October 24, 2013 State food and drug administration released 1th come into force December 1, 2013) Chapter I General provisions

    First to standardize the State food and Drug Administration (hereinafter referred to as Office) the legislative process to ensure quality and improve efficiency, according to the People's Republic of China Law on legislation, the formulation of administrative regulations Ordinance, the rulemaking procedures Ordinance, the Archivist filing of regulations and regulations and other laws and administrative regulations, as well as the relevant requirements of the State, this provision is enacted.

Provisions of this article apply to the following legislation:

(A) preparation of the food and Drug Administration long-term legislative planning and the annual legislative programme;

(B) the food and drug administration laws or administrative regulations to enact, amend or repeal proposals;

(C) draft, submitted to the food and Drug Administration draft laws and administrative regulations;

(D) according to the general duty to enact, amend, repeal and interpretation of the regulations;

    (V) other relevant legislation.

Thirdly, General legislative work in the Secretary, under the leadership of centralized management by the Legal Division, the Division in accordance with the Division of responsibilities is responsible for:

(A) the Legal Division is responsible for the legislative work of the Organization, coordination, including medium-and long-term planning and preparation of the annual legislative programme and organizational implementation, draft legislation draft review, reported to the General Council meetings to consider and prepare for the record; responsible for comprehensive legal and administrative regulations of the draft; responsible for the legality of normative documents review and so on.

    (B) the departments responsible for their own business within the scope of legislation, including legislative projects, participation in legislative planning, proposing draft legislation and in consultation with the relevant departments and units, the drafting of draft and notes, prepare the examination materials.

    Article fourth food and drug supervision work in accordance with legislation, the principles of scientific and democratic legislation, following the objective law, persist in reform and innovation, and improve administrative efficiency to ensure uniformity of the legal system, to safeguard fairness and justice.

    Fifth article content should be well prepared and not verbose, logic, explicit, specific, clear and accurate, and norms, concise, with maneuverability.

    Chapter II establishment

Sixth rule of law Division under the legislative work of the NPC Standing Committee and the State Council, organizations demonstrate and notify the food and drug administration law and administrative regulations to establish the project proposals.

Divisions Bureau of food and drug supervision work, research and demonstration project proposals and propose legal and administrative regulations; legislation involves a number of departments responsibilities, and it is difficult to determine the main responsible for the Division's comprehensive legal and administrative regulations, research project proposals put forward by the Legal Division.

    Project proposals of laws and administrative regulations, upon approval by the General leadership, in accordance with the regulations in Bureau forms submitted to the national people's Congress, the State Council.

Seventh rule of law Division should be collected from the last quarter of each year, to the Division an annual rulemaking and modify project proposals.

    Divisions reporting regulations project proposals shall specify the project name, necessity and feasibility of legislation, needed to solve the main problem, intended to establish or improve the main system, has carried out relevant work, project and schedule, and so on. Eighth regulatory matters should belong to enforce the law or administrative regulations, decisions and orders of the State Council.

    Involving more than two departments of the State Council on matters within the competence of, and should be brought to the regulations or by the competent administrative Department of the State Council jointly developed regulations.

Nineth food and drug regulatory agency of provinces, autonomous regions and municipalities (hereinafter referred to as the provincial food and drug regulators) may appeal to the administration of laws, administrative regulations and rules of the project proposal.

Citizens and organizations through the mail, Internet mail in the form submitted to the Office relating to the food and drug administration laws, administrative regulations and rules of the project proposal.

    Legal Secretary receives project proposals, in accordance with the Division of responsibilities referred to the Division Council or, depending on function research.

    Tenth Law Secretary to devise the Administration's annual legal and administrative rules and regulations the legislative scheme, should work with the legislation plan of the NPC and the State Council legislative scheme of the dovetail bureaus reporting regulations project recommendations and consider the situation.

    11th legislative plan should be focused, integrated, full justification, a prudent option, high degree of social concern and supervision urgent projects should be prioritized.

12th annual legislative programme includes laws, administrative regulations and rules of the project name, head of drafting Department, project, schedules, and so on. Regulations legislative project is divided into two tranches.

    On the legislative conditions, issued during the year, as a project conditions were not ripe, needs promptly and timely promote the introduction of, can be classified as the second item.

    13th legislative programme should be reported to the General Council in the first quarter of each year for consideration by, issued a document issued the Department of units directly under the Board, with a copy to the provincial food and drug regulators. 14th legislative programme should be strictly enforced. Rule of law Division is responsible for organizing and supervising the implementation of the legislative programme, to grasp the legislative progress of the project and to report to the General Council implementation of the annual legislative programme.

    Responsibility of drafting Secretary Office shall in accordance with the timely submission of draft legislation draft legislative programme.

    15th according to general practice, it is necessary to adjust legislation, apply in writing by the relevant departments, reviewed by the Legal Division, reports to the General Council meeting.

    Chapter drafting 16th in the laws, administrative regulations and rules of the annual legislative programme, project applications by departments responsible for drafting project involving several departments responsibilities, dominated by a Division authority drafted relevant departments cooperate, co-sponsor the draft legislation.

Comprehensive legal and administrative regulations drafted by the Legal Division. Drafting departments shall determine the person responsible leadership of a Director, and to designate a person responsible for specific tasks.

    Legal Secretary designate support, full participation.

Article 17th draft departments should conduct in-depth studies and understand the regulatory history, present situation and existing problems, research experience, and practical draft legislation. Drafting departments should be widely consulted in the drafting process the relevant departments, authorities, industry associations, grass-roots law enforcement and citizens advice.

Comments can take seminars, feasibility study meeting, hearing, open call for proposals for field research, Internet and other forms.

    Drafted during the draft legislation for comments to the public sector, drafting instructions that should be.

    18th draft legislation related to the food and Drug Administration institutional mechanisms, regulatory measures and significant adjustments, or to civil interests, may have a significant impact on the food and drug industry, and drafting departments shall organize social, economic and other aspects of risk assessment form assessment report as a basis for decision-making.

19th draft legislation related to other Department duties or work closely with other departments, drafting departments should take the initiative to seek advice, consultation and agreement with the relevant departments.

    After full consultations, units of the system are still opposing the draft law have different views, should be reported to the Office in charge of the leadership decision system opposite the relevant departments have different views on the draft law, by the drafting Department with full consensus still cannot be reached after consultations, should be submitted for review in draft legislation indicate the circumstances and reasons.

Article 20th draft departments should seriously study and taken all these views, opposing a draft law modifying the form draft, Director of the study, by the works after the signing, the General in charge of the leadership agreed, accompanied by the preparation of notes and related materials submitted to the Legal Division for review.

Drafting instructions should be on legislation necessity and feasibility, the basis, the establishment or improvement of the main institutional and regulatory measures, interested parties and the adoption of conditions, the need for regulations and normative documents on the clear description of the situation.

    Related materials include research reports, both at home and abroad concerned about legislative information, summary advice, Forum feasibility study meeting records, hearing transcripts, assessments, etc.

    The fourth chapter reviews

    Article 21st law drafting departments submit material before the Secretary shall within 5 working days from the date of the formal examination, does not meet the requirements of the provisions of article 20th, requires the drafting Department filled in the 15th related materials; fails to fill, back drafting departments. 22nd Division to meet the review requirements of the legal system, in principle, should be finished in 30th examination as to substance.

Substantive examination include the following:

(A) compliance with statutory authority and procedures;

(B) compliance with the spirit and principles of the Constitution;

(C) compliance with provisions of laws and administrative rules and regulations, and other higher-level law, the existence of illegal provisions of an administrative license, the administrative punishment and administrative compulsory;

(D) properly handle the views of the relevant departments, units and citizens;

(E) has a reasonable and feasible;

(Vi) compliance with legislative requirements;

    (VII) other contents need to be reviewed. Article 23rd draft legal Secretary can involve major problems again for comments.

Consultation may take the following forms:

(A) seek the advice of the provincial food and drug supervision departments in writing;

(B) consult with relevant departments, units and expert opinions in writing;

(C) field research, listen to the views of grass-roots units and individuals;

    (D) organizing seminars, feasibility study meeting, hearing, and so on. Article 24th draft by the Legal Division review changes, mature, and reported to the Office in charge of the leadership of the validation. After the General in charge of the leadership agreed to, in China the Government legal information online for public comment, and in the administration of Government websites.

    Comment time is normally less than 30th. 25th Division in the review of the legal system in the process of modifying article should communicate fully with the drafting departments fully understand the intentions of the drafting, background, regulatory processes, and solve problems, etc.

    Drafting departments should actively cooperate with and described the situation to provide relevant information.

    Article 26th draft reviewed and revised in accordance with the requirements of, and agreed with the relevant departments, legal Secretary works will study, the Director after the signing, the General in charge of the leadership agreed, required reports to the General Council meeting.

27th draft one of the following circumstances, works by the legal Secretary will study, returned after the signing of the Director in drafting departments, drafting Department modified can again declare:

(A) the basic conditions are not ripe for legislation;
(B) the drafting Department of the main system has been insufficient research and feasibility studies;

(C) the system provided for in the relevant departments of the controversy, drafted without consultation with the authorities of the Department;

    (D) other circumstances that do not meet the requirements.

    The fifth chapter review and publication

    28th legislative consideration of the draft report to the General Council meetings, apply in writing by the Division of law, draft laws and administrative rules and regulations and draft drafting instructions, reported Central Office leadership agreed, pay Office to arrange a meeting. 29th General Council meetings to consider laws, administrative regulations and rules at the draft, described by the Legal Division. Description of the main elements include: legislative background, the drafting process, the main contents and the major issues need to be considered.

    If necessary, the drafting Department of legislative assessment, implementation procedures, and other related issues are added.

Article 30th laws, administrative regulations and draft regulations considered by the administration of Council meetings after the Division shall, in conjunction with the drafting of the legal system according to modify general deliberation Council meetings.

Laws, administrative rules and regulations after the Bill is signed by the Secretary to submit to the State Council, draft regulations submitted to the order signed by the Secretary to the public.

    Laws, administrative regulations and draft regulations considered by the administration of Council meetings was not adopted, drafted by the Legal Division for the Department in accordance with the requirements of the revised, again reported to the General Council meeting.

31st organised by the Directorate as well as with other departments of the State Council jointly issued a regulation, adopted by the General Council meeting and issued by the Director, sent a joint release issued by the Department.

    Hosted by the other departments of the State Council and published jointly with the General regulations, in conjunction with the relevant departments to review comments made by the Legal Division, by the consent of the Office in charge of the leadership newspaper issued by the Secretary.

Command of the 32nd article published by State regulations, and shall set forth the enactment organ, the number of regulations, rule name, General Council meetings by date, execution date, signature and date of publication, the Secretary.

    Administration and other departments of the State Council published regulations, developed jointly by the Secretaries and heads of departments jointly signed release, use the command sequence number of the host authorities.

    33rd regulation should come into force after the 30th from the date of promulgation, but announced immediately after the execution could affect regulatory purposes, can come into force on the date of promulgation.

    After signing the 34th rule, rule of law Division printed complete text of the regulations should be distributed to the provincial food and drug regulators and the divisions of Administration Council, the units directly under them, and timely regulatory texts and interpretation notes published in the administration of Government Web sites and related media.

    Sixth chapter filing and interpretation

    35th general regulations published in the 30th, by the Legal Division in accordance with the Archivist filing of regulations and relevant provisions of the Ordinance, the submission to the State Council for the record.

    Article 36th food and drug administration laws, administrative regulations, provisions need to further clarify the meaning and limits of, made by the relevant departments explained the request, reviewed by the Legal Division, reported to the Office after the leaders agreed to, in the form of Office issued a report to the national people's Congress, the State Department explained.

37th under any of the following circumstances, the Directorate is responsible for the interpretation of regulatory provisions:

(A) the provisions of regulations needs to further clarify the specific meaning or boundaries;

(B) the enactment of regulations there is a new situation, need a clear basis or the scope of its application.

Needs to explain the provisions of the regulations, made by the relevant departments explained draft opinion, reviewed by the Legal Division, reported to the Office after the leaders agreed to, in the form of Office issued a release, and open to the public.

    Regulatory provisions explained the regulations shall have the same effect.

    Article 38th in the food and drug administration law enforcement process involving legal and administrative rules and regulations on specific applications, preliminary comments from relevant departments, reviewed by the Legal Division, Bureau approval, in the form of Office issued a release, and open to the public.

    The seventh chapter assessment, cleaning and Assembly

39th rule went into effect, legal Secretary, in conjunction with relevant departments can be organized as needed after legislative assessment of the social effects of the implementation of regulations.

    Assessment results should be used as important reference to the amendment or repeal regulations.

    40th legislative evaluation questionnaires, field research, forums, feasibility study meeting, listen to the views of the community; or Commission higher education institutions, research institutions, industry associations and other third party commitments to the community. 41st in addition to laws and administrative regulations in accordance with regulations need to be cleaned out, Legal Division regularly organizes the full liquidation of the regulations of the Division.

    Results announced to the public through the administration of Government Web sites.

42nd rule has one of the following shall be repealed:

(A) be repealed or modified due to relevant laws, administrative regulations, losing legislative basis;

(Ii) provisions have been completed or actual change, there is no need to continue;

(C) the main content regulations be replaced by higher-level laws or other regulations concerned;

(D) other circumstances that should be abolished.

    Abolition of regulatory documents, in principle, in the form of General command published.

    Article 43rd Legal Division is responsible for periodically updating the food and drug administration laws, administrative regulations and rules was compiled, the provincial food and drug regulators and the Administration divisions and directly subordinate units.

    Eighth chapter review of regulatory documents and cleaning

    44th Office for the implementation of laws and administrative rules and regulations, development of administrative counterpart's right and obligation of generally binding normative documents, which can repeatedly apply, its work in the light of the provisions of article 17th to 19th implementation.

    Drafting normative documents of the 45th Division, should be reported to the Legal Division legal review, after signing by the legal Secretary, according to prescribed procedures in the form of Office issued a release, and open to the public. 46th Division of legal normative documents the Bureau shall organize regular divisions cleaned up.

    Results announced to the public through the administration of Government Web sites, compiled by the Legal Division, the provincial food and drug regulators and the Administration divisions and directly subordinate units.

    Nineth chapter by-laws

    47th content of the formulation of regulations and regulatory documents concerning Foreign Affairs, shall, in accordance with the State Council on further regulating the sector of foreign regulations and normative documents: notice of (State Office (2006), 92nd), prior to the official release to report to the State Council.

    48th regulations and regulatory documents related to the content in accordance with the relevant rules of the World Trade Organization to communicate draft departments should submit the draft legislation before the Legal Division review and agreed by the Administration in charge of the leadership, informed by Convention.

    Food and drug administration in 49th article of the rules for foodstuffs (health food), pharmaceuticals, medical devices, cosmetics, and supervision and management. 50th article of the regulations come into force on December 1, 2013. April 30, 2002, issued by the State food and drug administration regulations on the procedure of administrative legislation (formerly the State drug authority made 33rd) repealed simultaneously.