NMPA solicits opinions on the Measures for the Administration of Drug Standards, and Chinese Pharmacopoeia and drug standards are national standards!

In order to further standardize and strengthen the management of drug standards and ensure the safety, effectiveness and quality controllability of drugs, the State Food and Drug Administration organized the drafting of the Measures for the Administration of Drug Standards (Draft for Comments), which is now open to the public for comments
.

The public comment period is from December 15, 2022 to January 14
, 2023.
Interested and individuals can feedback to yhzcszhc@nmpa.
gov.
cn
。 Please indicate "Feedback on Drug Standard Management Measures"
in the subject of the email.

Annex:

1.
Measures for the Administration of Drug Standards (Draft for Solicitation of Comments)

2.
Drafting instructions for the Measures for the Administration of Drug Standards

3.
Feedback form of the Measures for the Administration of Drug Standards (Draft for Comments).

General Department of the State Food and Drug Administration

December 14, 2022

Measures for the Administration of Drug Standards (Draft for Solicitation of Comments)

Chapter I General Provisions

Article 1 (Purpose and Basis) These Measures
are formulated in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on the Administration of Epidemic Seedlings, and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, in order to strengthen the management of drug standards, ensure the safety, efficacy and quality controllability of drugs, and promote the high-quality development of drugs.

Article 2: (Standard Classification of Drugs) Drugs shall comply with national drug standards
.

The Pharmacopoeia of the People's Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") and drug standards promulgated by the drug administration department under the State Council are national drug standards
.

Drug registration standards refer to the quality standards
for specific drugs of specific applicants that have been reviewed by the drug evaluation agency set up by the drug regulatory department under the State Council and approved by the drug regulatory department under the State Council.
The applicant shall implement the registration criteria
.

Article 3 (Scope of Application of the Measures) The planning, project establishment, formulation, revision, approval, promulgation, implementation, repeal, supervision and management of national drug standards shall apply to these Measures
.

The management of drug registration standards shall be carried out
in accordance with the relevant laws and regulations on drug registration.

Local drug standard management shall be implemented
with reference to these Measures.

Article 4 (Positioning of Drug Standards) The variety standards, drug registration standards and local drug standards in the national drug standards shall generally meet the relevant general technical requirements
of the Chinese Pharmacopoeia.

The general technical requirements included in the Chinese Pharmacopoeia include general principles of preparations, other general principles and general testing methods
.

The guiding principles contained in the Chinese Pharmacopoeia are recommended technical requirements
for guiding the formulation and revision of drug standards and improving the level of drug quality control.

Article 5 (General Principles of Drug Standards Work 1) The management of drug standards shall implement the relevant laws, regulations, guidelines and policies of the State Drug Supervision and Administration, and adhere to the principles of
scientific advancement and practical norms.
In the process of formulating and revising pharmaceutical standards, relevant departments shall conduct in-depth investigation and demonstration, widely solicit opinions, ensure the scientificity, standardization, timeliness and applicability of standards, and take into account the social, economic and ecological benefits of standards
.
Encourage the application of scientifically advanced, affordable technical methods to pharmaceutical standards
.

Article 6 (General Principles of Drug Standards Work 2) The national drug standard management work implements a working mechanism
led by the government, with enterprise entities and social participation.

The National Pharmacopoeia Commission strengthens the top-level design of the drug standard system, grasps the overall standard research direction, and gives full play to the role of
national drug standards in protecting and promoting public health.

Drug marketing authorization holders and pharmaceutical manufacturers shall implement the main responsibility of enterprises, promptly assess and improve drug standards, and improve drug quality
.

The drug regulatory department under the State Council encourages enterprises, social organizations, inspection institutions, scientific research institutions or individuals to participate in drug standards work and put forward reasonable opinions and suggestions
.

Article 7 (General Principles of Drug Standards Work 3) Encourage international exchanges and cooperation on drug standards, and strengthen international coordination
of drug standards.

Article 8: (General Principles of Drug Standards Work 4) Relevant persons involved in drug standards work shall have confidentiality obligations for technical secrets, trade secrets, undisclosed information, or confidential business information and data in drug standards work
.

Article 9: (Specific Measures for Drug Standards Work) The National Pharmacopoeia Commission shall strengthen the capacity building of drug standard research, continuously improve the standard management system and measures, actively promote the action plan for improving drug standards, continue to strengthen the construction of the drug standard system, strengthen the construction of standard informatization, improve the level of public standard services, and promote the high-quality development of
drugs.

Chapter II: Management Duties

Article 10: (Duties of the State Bureau) The drug regulatory department under the State Council shall perform the following duties:

(1) Organizing the implementation of laws and regulations related to the management of drug standards, and organizing the formulation of work systems for the management of drug standards;

(2) Organizing a pharmacopoeia committee in conjunction with the competent health department under the State Council to be responsible for the formulation and revision of national drug standards;

(3) promulgating and abolishing national drug standards;

(4) Guide and supervise drug standard management efforts
in accordance with law.

Article 11: (Duties of Permanent Institutions for the Administration of National Drug Standards) The National Pharmacopoeia Commission performs the following duties:

(1) Organizing the preparation, revision and compilation of the Chinese Pharmacopoeia and its supporting standards, and formulating and revising the drug standards
of other countries.

(2) Participate in the formulation of relevant systems and working mechanisms
for the management of drug standards.

(3) Responsible for the organization, coordination and service guarantee of the professional committees of the Pharmacopoeia Committee
.

Article 12 (Duties of the Executive Committee and Special Committee of the Pharmacopoeia Commission) The Charter of the Pharmacopoeia Committee is the basic guideline of the Pharmacopoeia Commission, which is deliberated and adopted
by the General Assembly of the Whole Committee of the Pharmacopoeia Commission.
The Pharmacopoeia Commission shall establish an executive committee and professional committees
in accordance with the Charter of the Pharmacopoeia Commission.
The Executive Committee and all professional committees shall strictly abide by the provisions
of the Charter of the Pharmacopoeia Committee.
The Executive Committee is responsible for deliberating and approving drug standard development strategies and major decision-making matters
.

The professional committee is responsible for the review of the drug standards of the specialty and its standard scientific research projects, and solves other problems
in the drug standards of the specialty.

Article 13 (Responsibilities for Calibration of Reference Materials) The China Academy of Food and Drug Control is responsible for the calibration of national drug reference materials
.

Article 14: (Responsibilities for the Administration of Registration Standards) The drug evaluation bodies established by the drug regulatory department under the State Council shall be responsible for the technical review of drug registration standards
.
According to the needs of drug supervision and standard management, the National Pharmacopoeia Commission organizes and carries out the transformation
of drug registration standards into national drug standards in a timely manner.

The China Institute for Food and Drug Control and provincial drug inspection agencies are responsible for drug registration inspection and standard review
.

Article 15: (Administrative Duties of Provincial Drug Administration Departments) Each provincial drug regulatory department shall be responsible for the following work within its administrative area:

(1) Organizing the implementation of laws and regulations on the management of drug standards;

(2) Organizing and participating in the formulation and revision of drug standards;

(3) supervise the implementation of drug standards;

(4) Organizing the formulation and revision of local drug standards
within that administrative region.

Chapter III: Planning and Project Establishment

Article 16 (Work Plan for National Drug Standards) The drug regulatory department under the State Council shall organize the National Pharmacopoeia Commission to formulate the outline for the preparation of the Chinese Pharmacopoeia, which shall be implemented
after deliberation and approval by the plenary meeting of the Pharmacopoeia Committee.

Article 17 (Selection of Pharmacopoeia Varieties) The National Pharmacopoeia Commission, in accordance with the requirements of the outline of the Chinese Pharmacopoeia, shall include the drug standards that meet the principles of variety selection into the Chinese Pharmacopoeia and its supplements
.

The Chinese Pharmacopoeia shall include drugs
commonly used in clinical practice, with precise efficacy, safe use, mature technology and controllable quality.

Article 18: (Suggestions for Project Establishment) Drug regulatory departments at all levels, the National Pharmacopoeia Commission, the professional committees of the Pharmacopoeia Commission, drug marketing authorization holders (pharmaceutical manufacturers), operating enterprises, use and inspection institutions, scientific research institutions, social groups and individual citizens may put forward proposals
for the formulation and revision of national drug standards.

Article 19 (Project Establishment and Deliberation) The National Pharmacopoeia Commission organizes professional committees to deliberate on project proposals, publish the proposed project course records, and collect topics to undertake
.

According to the collection situation, the National Pharmacopoeia Commission organizes professional committees to deliberate, determine the project list and undertaking, and publicize
it.
After the end of the publicity period, objections are handled, and the contents of the course and undertaking of the project are published
.

Chapter IV: Formulation and Revision

Article 20: (Steps for Formulating and Revision of Standards) The formulation and revision of national drug standards shall be carried out
in accordance with the procedures for drafting, review, publicity, approval, and promulgation.

Where major emergencies such as drug safety or public health are involved, consistent evaluation of varieties may initiate procedures for accelerating the formulation or revision of national drug standards as needed, and accelerate the process on the premise of ensuring the quality of the
formulation or revision of national drug standards.

Article 21: (Requirements for Formulating and Revision of Standards) The drafting of national drug standards shall comply with requirements such as national drug standards and technical specifications
.
Standard drafting (lead) is responsible for sorting out relevant technical data, forming a draft national drug standard, and submitting relevant research materials to the National Pharmacopoeia Commission for review
.

Article 22 (Standard Review) The National Pharmacopoeia Commission organizes professional committees to conduct technical reviews
of the draft national drug standards and related materials.

Based on the review opinions and conclusions, the National Pharmacopoeia Commission shall formulate a draft
of national drug standards for comments.
The draft of national drug standards for solicitation of comments shall be accompanied by instructions for the formulation or revision of standards, and information such as drafting, review, and active participation shall be marked
.

Article 23: (Publicity of Standards) The draft of national drug standards for solicitation of comments shall be publicly announced and widely solicited for comments, and the period of publicity is generally 1 month to 3 months
.

Article 24 (Handling of Feedback) Where the feedback involves technical content, the National Pharmacopoeia Commission shall promptly send the comments to the standard drafting (lead), and the drafting (lead) shall conduct research, and submit the handling opinions to the National Pharmacopoeia Commission, which shall organize a technical review and decide whether to publicize
it again.

Article 25: (Establishment of Reference Materials) For national drug standards that require new national drug reference materials, the China Institute for Food and Drug Control shall promptly carry out corresponding preparatory work
before the promulgation of relevant national drug standards.

Article 26: (Archives Management) The drafting (lead) of drug standards shall preserve the original data, original records and relevant materials in the process of standard research, and promptly archive
them in accordance with the requirements of the archives management provisions.

In drafting (leading) drug standards, specimens of Chinese medicinal materials used in drafting or revising standards shall be sent to drug inspection institutions set up or designated by the drug regulatory department under the State Council for collection
.

Chapter V: Ratification and Promulgation

Article 27 (Promulgation of Pharmacopoeia) The Chinese Pharmacopoeia is promulgated every 5 years
.
The Chinese Pharmacopoeia and its supplements are promulgated and implemented
after approval by the drug administration department under the State Council.

The supplement to the Chinese Pharmacopoeia has the same legal status
as its corresponding current version of the Chinese Pharmacopoeia.

Article 28 (Submission of Draft Standards) The National Pharmacopoeia Commission shall report the draft of the Chinese Pharmacopoeia, the draft national drug standards and relevant technical materials to be promulgated to the drug regulatory department
under the State Council.

Article 29: (Standard Approval) The drug regulatory department under the State Council shall make a decision
on whether to approve the materials reported by the National Pharmacopoeia Commission.
If approved, the Chinese Pharmacopoeia shall be promulgated; For the drug standards of other countries, they shall be promulgated in the form of the "National Drug Standards Promulgation
".

Chapter VI: Implementation and Repeal

Article 30 (Implementation of Standards) Varieties of previous editions of the Chinese Pharmacopoeia that are not included in the new edition of the Chinese Pharmacopoeia shall still be implemented in accordance with the drug standards included in the original Chinese Pharmacopoeia, except for varieties whose drug standards have been abolished due to safety, effectiveness, etc.
, but shall meet the general technical requirements
of the new edition of the Chinese Pharmacopoeia.

Article 31: (Licensor's Responsibility) After the promulgation of national drug standards, drug marketing authorization holders and pharmaceutical manufacturers shall promptly assess
the applicability of the national drug standards to the drugs they produce and their registration standards.

Where the drug registration standards do not conform to the relevant requirements of the national drug standards or the inspection items are not applicable, the drug marketing authorization holder and pharmaceutical manufacturer shall revise them in accordance with the provisions of the Measures for the Administration of Drug Registration; In accordance with the relevant provisions on the management of post-market changes of drugs, submit supplementary applications or filings to the drug evaluation agency set up by the drug regulatory department under the State Council or the corresponding provincial drug regulatory department, and implement them
after approval.

Article 32: (Repeal Circumstances) In the following circumstances, its drug standards shall be abolished:

(1) After the promulgation and implementation of the national drug standards, the original national drug standards of the same variety;

(2) Standards for drugs whose marketing authorization has been terminated;

(3) The safety, effectiveness, and quality controllability of drugs do not meet the required drug standards
.

Chapter VII: Local Drug Standards

Article 33: (Landmark Classification) The drug standards promulgated by the provincial-level drug regulatory departments are local drug standards
.

Local drug standards include local standards for medicinal materials promulgated by provincial drug regulatory departments that are not stipulated in national drug standards, specifications for the preparation of Chinese medicine pieces and preparation standards
for medical institutions.

For varieties that cannot be met by national drug reference materials added to local drug standards, the drug inspection agency of the province, autonomous region or municipality directly under the Central Government is responsible for making overall arrangements for the preparation, calibration, storage, distribution and use
.

Article 34: (Promulgation of Landmarks) The provincial-level drug regulatory departments shall, prior to promulgation, organize compliance reviews
of the local drug standards formulated in accordance with national laws, regulations, relevant administrative provisions, guiding principles, etc.

Article 35: (Landmark System Revision) The provincial-level drug regulatory departments shall formulate and revise local drug standards, and within 30 days of the promulgation of the standards, report the local drug standard approval documents, local drug standard texts and preparation instructions to the drug regulatory department under the State Council for the record, and promptly release relevant information
on local drug standards.

Article 36: (Prohibited Circumstances) Local drug standards prohibit the inclusion of the following varieties:

(1) Medicinal materials and Chinese herbal tablets that do not have a history of clinical practice in the region;

(2) Medicinal materials, Chinese medicine pieces and proprietary Chinese medicines that have national drug standards;

(3) Newly discovered medicinal materials in China;

(4) new medicinal parts of medicinal materials;

(5) importing, introducing or introducing from abroad animals, plants, minerals and other products that are not traditionally used in China;

(6) animal and plant products processed by biotechnology such as genetic modification;

(7) Other varieties
that are not suitable for inclusion in local drug standards.

Article 37: (Repeal of Landmarks) After local drug standards are included in the national drug standards and promulgated and implemented, the local drug standards shall be abolished
on their own.

Chapter VIII: Supervision and Management

Article 38: (Obligation to Collaborate) When supervising and managing the implementation of drug standards, the supervised management shall cooperate, and must not refuse or conceal the situation
.

Article 39: (Handling of Reports) Any person or individual may report or reflect violations of drug standards to the drug regulatory departments
.
Departments that receive reports or reflections shall promptly handle
them in accordance with provisions.

Article 40 (Principles of Judgment) The provisions set forth in pharmaceutical standards shall apply to drugs
produced in accordance with the requirements of the Good Manufacturing Practice for Pharmaceuticals.
Any drug produced in violation of Good Manufacturing Practice or with unapproved additives cannot be considered to be in compliance with the requirements
even if they meet the drug standards or the added substances or related impurities are not detected in accordance with the pharmaceutical standards.

Chapter IX Supplementary Provisions

Article 41: (Definitions) "Drug standards" as used in these Measures refers to technical requirements
formulated on the basis of the physical, chemical and biological characteristics of the drug itself in accordance with conditions such as source, prescription, preparation method, transportation, and storage, to test whether the quality of a drug meets the requirements for medicinal use, and to measure whether its quality is stable and uniform.

National drug reference materials refer to substances used for physical, chemical and biological testing of drugs in national statutory drug standards, with certain characteristics or quantitative values, used for calibration equipment, evaluation of measurement methods, assignment or identification of test drugs
.

National drug reference materials are divided into five categories, including: standards, reference substances, control extracts, control medicinal materials, and reference substances
.

Article 42: (Management of Chinese Medicine Standards) Where there are special requirements for the management of Chinese medicine standards, they shall be implemented
in accordance with the relevant provisions on the management of Chinese medicine standards.
The special provisions on the administration of traditional Chinese medicine standards shall be separately studied and formulated
by the drug regulatory department under the State Council.

Article 43 (Management of Varieties of Medicinal Excipients) The standards for medicinal excipients included in the Chinese Pharmacopoeia are the basic standards for their quality control, and the corresponding standards
of the Chinese Pharmacopoeia must be implemented for pharmaceutical excipients that claim to comply with the Chinese Pharmacopoeia.

Article 44: (Standard Numbering) The numbering rules for national drug standards shall be separately studied and formulated
by the drug regulatory department under the State Council.

Article 45:(Interpretation Department) The drug regulatory department under the State Council is responsible for the interpretation
of these Measures.

Article 46:(Implementation Date) These Measures shall take effect
on XX, 202X.