The General Administration issued a document that there have been major changes in drug standards! Affects all pharmaceutical companies

Recently, the Drug Administration Law, soliciting opinions, and drug standards will be adjusted soon!

It is worth noting that on November 22 last year, the General Administration also issued a draft of the "Administrative Measures for Drug Standards" for comments. There is a big discrepancy between the latest draft for comments and the old draft, and it seems that there is still a lot of uncertainty about the true face of the official draft.

On December 18, the State Food and Drug Administration issued the "Measures for the Administration of Drug Standards" (draft for comments) for public comments. Before January 18, 2018, all sectors of the community can submit comments.

The "Draft" makes it clear that drugs that do not meet the national drug standards shall not be produced, sold or used. After the promulgation of the national drug standards, a 6-month transition period for the implementation of the standards will be granted except in special circumstances. According to the "Draft for Comments", the varieties included in the "Chinese Pharmacopoeia" should be drugs that are commonly used in clinical use, have exact curative effects, are safe to use, have mature technology and controllable quality.

The "Draft for Comments" clarifies that drug standards include national drug standards, local drug standards and drug registration standards. The Chinese Pharmacopoeia is part of the national drug standards.

The "Chinese Pharmacopoeia" is published every 5 years, and the implementation of its supplements should be approved by the State Food and Drug Administration. Once the new version of "Chinese Pharmacopoeia" is promulgated and implemented, the original national drug standards of the same species will be abolished on their own.

▍New changes in drug marketing authorization

The "Draft" pointed out that the drug registration standard refers to the drug standard proposed by the drug marketing license applicant (drug manufacturer) in the process of drug registration and approved by the national drug regulatory department. A standard that someone (drug manufacturer) must implement.

The drug registration standards shall be implemented in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations. Drug marketing license holders (drug manufacturers) are encouraged to continuously improve drug standards.

After the promulgation of the Chinese Pharmacopoeia, drug marketing authorization holders (drug manufacturers) should promptly review the applicability of their drug registration standards. For drug registration standards that are inconsistent with the relevant requirements of the "Chinese Pharmacopoeia", the inspection items are less than or the quality indicators are lower than the "Chinese Pharmacopoeia", the drug marketing authorization holder (drug manufacturer) should follow the "Drug Registration Management Measures" Amend the regulations or implement the Chinese Pharmacopoeia.

During the transition period of standard implementation, drug marketing authorization holders (drug manufacturers) can implement the new standards in advance according to quality control risks. During the transition period for the implementation of the standard, the holder of the drug marketing authorization (drug manufacturer) shall carry out the inspection according to the original standard if the original standard is implemented; if the new standard is implemented, the inspection shall be carried out in accordance with the new standard.

For the test items included in the drug registration standard that are more than (including different) or the quality indicators are stricter than those stipulated in the Chinese Pharmacopoeia, the drug marketing authorization holder (drug manufacturer) shall implement the provisions of the Chinese Pharmacopoeia on the basis of , while implementing the corresponding items and indicators of the drug registration standards.

▍The local standard prohibits the collection of varieties

The "Draft" clarifies that the food and drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government formulate and revise local drug standards, and submit the local drug standard approval documents, local drug standard texts and preparation instructions to the State Food and Drug Administration within 30 days after the release of the standards. The General Administration will record and release relevant information on local drug standards in a timely manner.

The "Draft" pointed out that local drug standards prohibit the inclusion of the following varieties:

(1) medicinal materials and decoction pieces of traditional Chinese medicine with no history of clinical use in the region;

(2) Medicinal materials, Chinese herbal decoction pieces and Chinese patent medicines that have national drug standards;

(3) Newly discovered medicinal materials in China;

(4) New medicinal parts of medicinal materials;

(5) Non-traditional animals, plants, minerals and other products imported, introduced or cultivated from abroad that are not traditionally used in my country;

(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.

The latest text of the management measures for drug standards (draft for comments)

Chapter 1 General Provisions

Article 1 In order to standardize the formulation, revision, release and implementation of drug standards, and to strengthen the management of drug standards, these Measures are formulated in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and its implementation regulations.

Article 2 Drug standards include national drug standards, local drug standards and drug registration standards.

National drug standards include the Pharmacopoeia of the People's Republic of China and other drug standards promulgated by the State Drug Administration.

The local drug standards include the local medicinal material standards promulgated by the food and drug administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, the processing specifications of Chinese herbal decoction pieces, and the preparation standards of medical institutions.

Drug registration standards refer to the drug standards proposed by the drug marketing license applicant (drug manufacturer) during the drug registration process and approved by the State Drug Administration. ) standards that must be implemented. The drug registration standards shall be implemented in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations.

Other drug standards and drug registration standards promulgated by the State Drug Administration shall comply with the relevant general technical requirements of the Chinese Pharmacopoeia.

Article 3 The planning, planning, formulation, revision, examination and approval, promulgation, implementation, review, abolition, supervision and inspection of national drug standards shall be applicable to these Measures. The formulation and revision of local drug standards shall be implemented with reference to these Measures.

Article 4 The general rules and general rules of the "Chinese Pharmacopoeia" are the general technical requirements of drug standards, and drugs marketed within the territory of the People's Republic of China shall meet the general technical requirements of the "Chinese Pharmacopoeia".

Article 5 The national drug standards and the drug standards of the varieties included in the "Chinese Drug Catalog" shall be disclosed to the public in a timely manner.

Article 6 The State Food and Drug Administration shall be responsible for the administration of national drug standards.

The State Pharmacopoeia Committee is responsible for the formulation and revision of national drug standards.

The drug inspection agency established by the State Food and Drug Administration shall be responsible for the calibration of national drug reference materials.

The drug review agency established by the State Food and Drug Administration is responsible for the technical review of drug registration standards.

The provincial food and drug administration departments are responsible for the work of drug standards within their respective administrative regions, and organize the formulation and revision of local medicinal materials standards, processing specifications for Chinese herbal decoction pieces, and preparation standards for medical institutions within their respective administrative regions.

Article 7 The State Pharmacopoeia Committee shall undertake the selection and management of pharmacopoeia members.

Pharmacopoeia members shall abide by the relevant laws and regulations of the state, actively perform their duties and obligations in accordance with the principles of scientific rigor, objectivity and impartiality, and shall not participate in the review of drug standards for related varieties or issues of interest to them.

The composition of the Pharmacopoeia Committee shall be reported to the State Food and Drug Administration for approval and publication.

Article 8 The State Pharmacopoeia Commission shall uniformly stipulate the general technical requirements in the national drug standards, including:

(1) The generic name and professional technical term of the drug;

(2) Technical requirements for the formulation and content of drug standards;

(3) Relevant technical requirements for drug reference materials;

(4) Other technical requirements stipulated by laws and regulations.

Article 9 The work of drug standards shall implement the laws, regulations, guidelines and policies of the state drug supervision and administration, adhere to the principles of scientific and advanced, practical and standardized; ensure openness, fairness, and fairness, promote the continuous improvement of drug quality, and meet the needs of drug supervision.

Article 10 The state encourages the application of scientifically advanced and economically applicable technical methods to drug standards; encourages drug marketing license holders (pharmaceutical manufacturers) to continuously improve drug standards; encourages enterprises and social organizations or individuals to participate in the work of drug standards and propose reasonable comments and suggestions.

Article 11 The state encourages international exchanges and cooperation on drug standards, and actively participates in the international coordination of drug standards.

Article 12 Food and drug supervision and administration departments at all levels, relevant units and personnel involved in the work of drug standards shall be obliged to keep confidential the technical secrets and data submitted by the applicant.

Chapter 2 Planning and Planning

Article 13 The State Food and Drug Administration shall organize the State Pharmacopoeia Commission to formulate the national drug standard work plan.

The national drug standard work plan shall include the stage development goals, implementation plans and safeguard measures of the national drug standard work, and shall be announced by the State Food and Drug Administration.

Article 14 The State Pharmacopoeia Committee formulates the outline of the "Chinese Pharmacopoeia" according to the national drug standard work plan, and publishes it after deliberation at the general meeting of the Pharmacopoeia Committee.

Article 15 The State Pharmacopoeia Committee is responsible for the formulation and revision of national drug standards. Relevant departments and units may submit proposals or applications to the National Pharmacopoeia Committee every year for the establishment of standards that need to be formulated and revised, including the important issues to be solved, the background and reasons for the establishment of the project, and the basis for monitoring and evaluation of existing drug quality control safety risks. .

Individuals, enterprises and social organizations can put forward suggestions or applications for the establishment of national drug standards.

Article 16 The State Pharmacopoeia Committee organizes professional committees to review project proposals or applications, and select the drug standards that need to be formulated and revised to be incorporated into the national drug standard formulation and revision work plan.

Article 17 During the process of formulation and revision of national drug standards, the content of planned items may be adjusted according to the needs of drug standards work. For items that need to be adjusted, the standard drafting, review unit or other organizations and individuals may apply for it, and the implementation will be carried out after the review and approval of the State Pharmacopoeia Committee.

Article 18 The national drug standard work plan and plan shall be made public to the public.

Chapter III Formulation and Revision

Article 19 The State Pharmacopoeia Committee, in accordance with the national drug standard work plan, organizes the evaluation of approved or approved drug standards, and formulates and revises the national drug standards.

Article 20 The formulation and revision of national drug standards shall be carried out in accordance with the links of drafting, review, and publicity. In the event of major emergencies such as drug safety, the formulation or revision of national drug standards may be initiated as needed, and the work will be accelerated in accordance with relevant regulations.

Article 21 The drafting unit of the national drug standard shall study, formulate and revise the national drug standard in accordance with the requirements of the national drug standard technical specification, draft the standard draft, write the drafting instructions, and attach relevant research materials.

The drafting unit of the national drug standard shall widely solicit opinions and be fully responsible for the quality and technical content of the draft standard.

The draft standard submitted by the national drug standard drafting unit shall be subject to technical review by the drug inspection agency established or determined by the food and drug administration.

Article 22 After the drafting of national drug standards is completed, the standard drafting unit shall be responsible for sorting out relevant technical materials, forming a draft drug standard, and submitting relevant research materials to the State Pharmacopoeia Committee for review.

Article 23 For drugs that are not included in the national drug standard work plan, if the manufacturer voluntarily proposes to formulate or revise the national drug standard, the national drug standard may be developed in accordance with the provisions of Articles 21 and 22 of these Measures. Standard drafting work, and submit relevant materials as required.

Article 24 The State Pharmacopoeia Committee organizes professional committees to conduct technical review of the draft national drug standards and related materials.

Article 25 The State Pharmacopoeia Committee shall formulate a draft of the national drug standard for consultation based on the technical review opinions and conclusions of the national drug standard. Information such as the drafting unit (or individual) of the national drug standard, the reviewing unit, and the source of the sample should be marked in the draft for comments on the national drug standard.

Article 26 The national drug standard consultation draft shall be publicized to the outside world and widely solicited opinions. Under normal circumstances, the publicity period of the national drug standard consultation draft is 3 months.

Article 27 If the feedback comments involve technical content, the comments should be sent to the standard drafting unit in a timely manner, and the drafting unit will conduct research, put forward handling opinions and report it to the State Pharmacopoeia Commission, which will decide whether to publish it again after reviewing.

Article 28 For national drug standards that need to use new reference materials, the corresponding national drug reference materials shall be prepared before the promulgation of the national drug standards.

The establishment of national drug reference materials includes the steps of variety determination, reference material candidate research, reference material preparation, reference material quality standard establishment, reference material analysis and calibration, and reference material review and approval.

Article 29 The drafting unit of the drug standard shall complete the project on time and keep the original data during the standard research process.

The State Pharmacopoeia Commission implements the system of publicizing the responsible personnel of the species and avoiding conflicts of interest of the Pharmacopoeia committee members for the standard technical review work, and accepts social supervision.

Article 30 The State Pharmacopoeia Commission shall, in accordance with the requirements of the compilation outline of the Chinese Pharmacopoeia, include the standards of drugs that conform to the principle of variety selection into the Chinese Pharmacopoeia and its supplements.

Article 31 The varieties recorded in the "Chinese Pharmacopoeia" shall be drugs that are commonly used in clinical use, have definite curative effect, are safe to use, have mature technology and controllable quality. The selection principles for varieties included in the Chinese Pharmacopoeia shall be formulated separately.

Article 32 After the inclusion standards of the Chinese Pharmacopoeia are revised, the relevant contents shall be included in the new edition of the Chinese Pharmacopoeia or its supplements.

Chapter IV Approval and Promulgation

Article 33 The State Pharmacopoeia Committee formulates a draft of the national drug standard according to the publicity results of the national drug standard consultation draft, and promptly reports the draft, drafting instructions and comprehensive review comments to the State Food and Drug Administration.

Article 34 The State Food and Drug Administration conducts the review according to the comprehensive review opinions of the State Pharmacopoeia Committee, and makes an approval decision.

Article 35 The Chinese Pharmacopoeia is published every 5 years. The Chinese Pharmacopoeia and its supplements are promulgated and implemented after being approved by the State Food and Drug Administration. The supplementary version of the Chinese Pharmacopoeia has the same legal status as the current version of the Chinese Pharmacopoeia.

Chapter 5 Standard Implementation

Article 36 From the date of implementation of the national drug standards, the production, distribution, use, supervision and inspection of drugs shall be strictly implemented. Drugs that do not meet the national drug standards shall not be produced, sold or used.

Article 37 After the promulgation of the national drug standards, a 6-month transition period for the implementation of the standards shall be granted except in special circumstances.

During the transition period of standard implementation, drug marketing authorization holders (drug manufacturers) can implement the new standards in advance according to quality control risks. During the transition period for the implementation of the standard, the holder of the drug marketing authorization (drug manufacturer) shall carry out the inspection according to the original standard if the original standard is implemented; if the new standard is implemented, the inspection shall be carried out in accordance with the new standard.

Article 38 Once the new version of "Chinese Pharmacopoeia" is promulgated and implemented, the original national drug standards for the same variety shall be abolished on their own.

The varieties of the previous editions of the Chinese Pharmacopoeia that are not included in the new edition of the Chinese Pharmacopoeia, except for the varieties whose drug standards have been abolished due to safety, efficacy and other issues, are still in accordance with the original Chinese Pharmacopoeia before the implementation of the new standard. The drug standards shall be implemented, but shall comply with the general technical requirements of the new edition of the Chinese Pharmacopoeia.

Article 39 After the promulgation of the Chinese Pharmacopoeia, the drug marketing license holder (drug manufacturer) shall promptly review the applicability of its drug registration standards. For drug registration standards that are inconsistent with the relevant requirements of the "Chinese Pharmacopoeia", the inspection items are less than or the quality indicators are lower than the "Chinese Pharmacopoeia", the drug marketing authorization holder (drug manufacturer) should follow the "Drug Registration Management Measures" Amend the regulations or implement the Chinese Pharmacopoeia.

For the test items included in the drug registration standard that are more than (including different) or the quality indicators are stricter than those stipulated in the Chinese Pharmacopoeia, the drug marketing authorization holder (drug manufacturer) shall implement the provisions of the Chinese Pharmacopoeia on the basis of , while implementing the corresponding items and indicators of the drug registration standards.

Article 40 The holder of the drug marketing authorization (drug manufacturer) shall actively participate in the drafting of national drug standards, and provide relevant samples and materials as required. For drug marketing authorization holders (drug manufacturers) who take the initiative to participate in and undertake the drafting of national drug standards, the State Pharmacopoeia Committee shall publicize them in the draft for comments on drug standards.

Article 41 In order to further improve the level of drug quality control, the holder of the drug marketing authorization (drug manufacturer) may submit an application for revision of the implemented drug standards, and the manufacturer shall implement the application after being approved by the State Food and Drug Administration. registration standards.

Article 42 The drug marketing license holder (drug manufacturer) shall, in accordance with the relevant regulations, mark the implemented drug standards on the drug insert sheet and label.

Chapter VI Review and Repeal

Article 43 After the national drug standards are promulgated and implemented, a review shall be organized by the State Pharmacopoeia Committee in accordance with the development of national science, technology and social economy and the needs of drug quality supervision and management. The review period generally does not exceed 5 years.

Article 44 After the State Pharmacopoeia Committee organizes an expert committee to evaluate the applicability of the national drug standards, it will put forward a review opinion, and deal with it according to the following situations:

(1) For the standards that do not need to be revised, put forward opinions that continue to be effective.

(2) For drug standards with outdated quality control methods, defective technologies, or inability to meet the needs of drug supervision, put forward opinions that need to be revised, and revise them in a timely manner.

(3) For drugs whose approval documents have been revoked by the State Food and Drug Administration due to safety and other issues, their drug standards shall be abolished at the same time.

Article 45 The State Pharmacopoeia Committee shall publicize the opinions on the review of national drug standards to the public for a period of 3 months. Based on the public feedback, a review report is drawn up, submitted to the State Food and Drug Administration for approval, and the review results are released.

Chapter VII Local Drug Standards

Article 46 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate and revise local drug standards, and submit the local drug standard approval certificate, local drug standard text and preparation instructions to the State Food and Drug Administration within 30 days after the standard is issued Record and release relevant information on local drug standards in a timely manner.

Article 47 Local drug standards prohibit the inclusion of the following varieties:

(1) medicinal materials and decoction pieces of traditional Chinese medicine with no history of clinical use in the region;

(2) Medicinal materials, Chinese herbal decoction pieces and Chinese patent medicines that have national drug standards;

(3) Newly discovered medicinal materials in China;

(4) New medicinal parts of medicinal materials;

(5) Non-traditional animals, plants, minerals and other products imported, introduced or cultivated from abroad that are not traditionally used in my country;

(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 48 The local drug standards shall comply with the general technical requirements of the Chinese Pharmacopoeia.

Article 49 After the local drug standards are incorporated into the national drug standards and promulgated and implemented, the local drug standards shall be abolished on their own.

Chapter VIII Supervision and Inspection

Article 50 The food and drug supervision and administration departments at all levels shall supervise and inspect the implementation of drug standards in the production and distribution of drugs as required.

Article 51 When supervising and inspecting the implementation of drug standards, the inspected unit shall cooperate, and shall not refuse or conceal the situation.

Article 52 Any unit or individual may report or report violations of drug standards to the Food and Drug Administration. The department that receives the report or report shall deal with it in a timely manner in accordance with the regulations.

Article 53 The provisions of the drug standards shall apply to the products produced in accordance with the relevant laws and regulations on drug administration. Any drug produced in violation of relevant laws and regulations on drug administration cannot be considered to be in compliance even if it passes the inspection according to the items set by the drug standards.

Chapter IX Supplementary Provisions

Article 54 The relevant data formed in the process of formulating drug standards shall be archived by relevant units in a timely manner in accordance with the requirements of archives management regulations.

Article 55 The numbering rules for national drug standards shall be formulated separately by the State Food and Drug Administration.

Article 56 The units and individuals who have made outstanding achievements in the research, formulation and revision of national drug standards may be rewarded.

Article 57 The meanings of the following terms in these Measures are:

Drug standard: It is a technical regulation formulated according to the physical, chemical and biological characteristics of the drug itself, according to the source, prescription, preparation method, transportation, storage and other conditions, to test whether the quality of the drug meets the drug requirements and to measure whether its quality is stable and uniform. .

Drug standard drafting unit: refers to the unit undertaking the research work on drug standards, including drug research, production, and inspection institutions.

Re-examination: refers to the process of re-examination of the technical content and index level of the pharmaceutical standard by the department that organizes the formulation of the pharmaceutical standard to confirm the validity, advancement and applicability of the standard.

Article 58 The formulation and revision of national standards for pharmaceutical excipients, packaging materials and containers that come into direct contact with drugs shall be implemented with reference to these Measures.

Article 59 The State Food and Drug Administration is responsible for the interpretation of these measures.

Article 60 These Measures shall come into force on XX, XX, 201X.