After 14 years, the Regulations on the Administration of Drug Specifications and Labels will be revised.

Source/NMPA
On May 15, the Drug Review Center of the State Drug Administration issued a Notice on Public Consultation on the Regulations on the Administration of Drug Specifications and Labels (Revised Version).notice that the drug specification is a statutory document containing important information about the drug, and the current Regulations on the Administration of Drug Specifications and Labels came into effect on 1 June 2006. With the promulgation and implementation of the newly revised Drug Administration Law and the Measures for the Administration of Drug Registration, there is an urgent need to revise the Regulations on the Administration of Drug Specifications and Labels.
in order to better implement the new requirements of relevant laws and regulations, the Drug Review Center to the "drug specifications and labels management regulations" and its rules to improve, the formation of a draft for comments, is now open to the community for comments. For comments from all sectors of the community, please provide feedback via email by 17:00 on 15 June 2020. (E-mail: wangshq@cde.org.cn; lijj@cde.org.cn)
it is understood that 14 new provisions have been added to the drug specification and label regulations (revised version) and two have been amended.
the main revision is to strengthen the holder to be the responsible subject of drug specifications and labels, responsible for the formulation, revision and maintenance of drug specifications and labels, and to add the "by counterfeit drug" penalty section.
Article 37 The listing license holder/declaration agent neglects, does not pay attention to the safety information of the drug, fails to revise the specification in time, results in the information of the listed drug specification is inaccurate, untrue, misleading, or does not provide sufficient safety information, warning information, etc., the drug will be sentenced to be a counterfeit drug, according to the provisions of the Drug Administration Law on counterfeit drugs.
Article 38 The holder of the listing license for generic drugs shall not pay attention to the revision of the specification of the generic drug (reference formulation), do not actively collect the safety information of the generic drug, and do not revise the generic drug specification in a timely manner, resulting in the inaccurate, untrue and misleading information of the specification, will be sentenced to counterfeit drugs and shall be punished according to the provisions of the Drug Administration Law on counterfeit drugs.
Article 39 "New Contents" If the drug specification information is inaccurate, misleading, and does not provide sufficient warning information, resulting in improper use of drugs by doctors and patients, causing all kinds of damage to patients, the holder of the drug listing license shall bear economic and legal liability in accordance with the law.
Article 40 The penalties for the instructions include, but are not limited to warnings, fines, suspension of sales or revocation of registration/approval numbers, etc., and disclose to the public the illegal acts and penalties of the holder of the drug listing license.
(State Drug Administration)
Article 1 To strengthen the dynamic management of the entire life cycle of drug specifications and labels, to construct a unified management system for drug specifications and labels, and to formulate these Provisions in accordance with the Drug Administration Law of the People's Republic of China and the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China.
Article 2 The specifications and labels of pharmaceutical products listed and sold within the territory of the People's Republic of China shall comply with the requirements of these Provisions.
Article 3 "New Contents" The applicant/drug listing license holder shall be the responsible subject of the drug specification and label, and shall be responsible for the formulation, revision and maintenance of the drug specification and label.
Article 4 The State Drug Administration shall be responsible for the approval and supervision of drug specifications and labels, and shall establish a full-time department to conduct the technical review and management of the specifications and labels. the labels of
drugs shall be based on the specification, shall not exceed the scope of the specification, and shall not be printed with texts and logos that imply efficacy, misleading use and inappropriate promotion of the product.
Article 5 Pharmaceutical packaging must be printed or labeled in accordance with the provisions, and shall not contain any other introduction or promotion of products, enterprises, text, audio-visual and other materials.
the minimum packaging produced by a pharmaceutical manufacturer for sale must be accompanied by a drug specification.
Article 6 The written expression of the drug description and label shall be scientific, standardized and accurate, the text clear and easy to distinguish, the logo clearly and strikingly, and there shall be no phenomenon such as the loss of the print, the alteration and so on.
Article 7 The drug specification shall use the standardized Chinese characters published by the State Language and Text Work Committee, and if other text comparisons are added, the expression of Chinese characters shall prevail. Article 8 of the
applies to chemicals and therapeutic biological products. Preventive biological products, cell therapeutic sises and diagnostic reagents can also be used for reference.
Article 9 Drug Specification is a statutory technical document based on scientific research data summary that contains important information such as drug safety and efficacy, and is an important basis for guiding pharmaceutical professionals and patients to use safely and rationally. The specific format, content and writing requirements for the specification of the drug shall be formulated and published by the State Drug Administration.
drug specifications shall contain the scientific information necessary for the safe and effective use of the drug, the contents must be detailed, informative, authentic and accurate, and shall not use propaganda language in any project, nor shall it contain false or misleading information. Cannot exaggerate validity, nor can you avoid adverse information.
Article 10 The description of the drug specification shall adopt the special vocabulary promulgated or standardized by the State, and the measurement unit shall comply with the provisions of the national standards for the expression of the name of the disease, the pharmaceutical professional noun, the name of the drug, the name and the result of the clinical examination.
Article 11 "New Content" The applicant is responsible for the preparation of the drug specification. When submitting the application for listing of new drugs, the applicant shall write the specification according to the data of the previous supportive research, and the drug review agency of the State Drug Administration shall be responsible for the technical examination of the specification, and shall submit the final draft of the specification formed by the discussion between the two parties to the report and review to the State Drug Administration for release.
Article 12 "New Contents" The holder of a new drug listing license is responsible for the revision and maintenance of the drug specification. During the life cycle of the drug market, the new drug market license holder shall actively collect information on the safety and effectiveness of the drug, including the report of the adverse reaction of the drug, the periodic safety revision report of the drug, the literature on the adverse drug reaction, and the data of the post-marketing research, etc., to carry out a summary analysis of the safety and effectiveness information of the new drug, and to carry out the benefit/risk assessment in a timely/regular manner. When it is clear that there are new safety risks to new drugs, or that existing data indicate that the current version of the specification is inaccurate, false or misleading, promptly revise the safety and efficacy information of the specification and report it to the drug review agency of the State Drug Administration for examination and confirmation.
New Content: For the discovery of new serious drug use risks, related to contraindications in the specification, special warnings and use precautions, dosage and medication methods, and other information that may significantly affect the patient's drug use benefit/risk ratio, the listing license holder shall submit an application for revision of the drug specification as soon as possible (the maximum time limit shall not exceed 3 months). For newly discovered non-serious adverse reactions or risks, an application for revision of the specification should be submitted within 3 to 6 months. For imported drugs, the listing licensee shall revise the specification in a timely manner based on its core database and safety issue assessment. For content affecting the safety and effectiveness of drugs, within 3 months of other international regulatory agencies revising the specification, the listing license holder must inform China's pharmaceutical regulatory authorities and propose domestic specification modifications."
Article 13 (Text Adjustment) Based on the results of the collected reports and analysis of adverse drug reactions, the drug regulatory department may require the drug market licensee to revise the drug specification. Drug licensing holders should respond within a month to regulatory requests for changes.
Article 14 For the purpose of protecting public health and guiding the correct and rational use of drugs, the holder of a drug market license may take the initiative to put a warning on the drug specification or label, and the State Drug Administration may also require the drug listing license holder to put a warning on the specification.
Article 15 After the drug specification has been approved for revision, the holder of the drug market license shall immediately notify the relevant pharmaceutical enterprises, user units and other departments of the revised contents, and use the revised specification simply as required.
Article 16 (Text Adjustment) When applying for re-registration, the holder of a drug listing license shall provide the clinical application of the drug during the time of listing, including the drug's effectiveness, safety summary report, and periodic safety revision report. If new safety problems are found, it is necessary to provide its analytical assessment report and, if necessary, supplement and revise the safety content in the drug specification.
Article 17 "New Content" For new drugs of improved type, on the basis of the specification of the original research drug (modified new drug), according to the characteristics of the modified new drug, such as structure, dosage form, optimization of the prescription process, change the route of administration, modify indications, etc., draft and formulate the drug specification, allow the specification to exist in some differences.
Article 18 "New Contents" The State Drug Administration shall make public the examination and revision of the new drug specification and the approved new drug specification on the official website for public inquiry.article 19 of the
, the specification of generic drugs shall be formulated with reference to the specification of the new drug /or reference formulation . In addition to indications subject to the approval of the State Drug Administration, as well as some information related to generic pharmaceutical companies, the main contents of the specification shall be consistent with the reference formulation specification specified by the State Drug Administration. The main contents of the drug specification of the same drug copied by different companies/manufacturers should be exactly the same. General name is the same and different specifications of varieties, the specified reference preparation may be different, but the specification should be as uniform as possible.
Article 20 " New Contents " The holder of the generic drug market license shall actively / regularly consult the drug specification as a new drug of the reference formulation , and shall promptly revise the generic drug specification when the information on the validity and safety of the reference formulation is revised . Article 21 of the
"New Contents" For those who withdraw from the market for non-therapeutic/safety reasons of the original research or reference preparation, the State Drug Administration will re-designate the reference formulation. If the reference preparation is listed in China, the listing license holder shall be responsible for the revision and maintenance of the drug specification. If the reference preparation is not listed in China, a generic drug license holder (such as the first) will be designated to undertake the revision and maintenance of the drug specification.
for clinical research data with systematic integrity, as if the non-analogformulationypreparation through consistency evaluation, depending on the specific circumstances, the content of the drug specification may be different from the reference formulation specification.
Article 22 The specification of a drug for a biosimilar drug shall be formulated on the basis of the original specification of the new drug and the research data of the similar drug, and shall be formulated in the light of the relevant requirements of the Guidelines for the Research and Evaluation of Biosimilar Drugs.the label of a drug in article 23
refers to the contents printed or affixed to the packaging of a drug, which is divided into internal and external labels. The drug's in-drug label refers to the label of the packaging that comes into direct contact with the drug, and the outer label refers to the label of the package other than the inner label. Article 24
The internal label of a drug shall contain the generic name of the drug, indications or functional treatment, specifications, usage, date of production, product lot number, validity period, production enterprise and other contents. if the
packaging size is too small to all indicate the above contents, at least the generic name, specifications, product batch number, expiration date and so on should be marked. Article 25
The label outside the drug shall indicate the generic name, composition, characteristics, indications or functional treatment, specifications, usage, adverse reactions, taboos, precautions, storage, production date, product batch number, expiration date, approval number, production enterprise seq. If the indications or function of the main treatment, usage, adverse reactions, taboos, precautions can not be all noted, the main content simply marked and noted the words "see the instructions".
Article 26 The label spent on packaging used for transportation and storage shall at least indicate the generic name, specifications, storage, production date, product lot number, validity period, approval number, production enterprise, and may also indicate the quantity of packaging, transportation precautions or other necessary contents such as marking as necessary.
Article 27 The label of apitic materials shall indicate the name of the drug, storage, date of production, product lot number, validity period, implementation standard, approval number, production enterprise, and must also indicate the quantity of packaging and transportation precautions and other necessary contents. article 28
The same drug specifications and packaging specifications are the same for the same drug production and packaging specifications produced by the same pharmaceutical manufacturer, and the contents, format and color of the labels must be the same;
the same drug produced by the same pharmaceutical manufacturer, respectively, according to prescription drugs and non-prescription drugs, the packaging color of the two should be significantly different. Article 29 of the
shall indicate the prominent place of the label for the storage of medicines with special requirements. The validity period in article 30 of the
drug label shall be marked in the order of year, month and day, the year shall be expressed in four digits and the month and day shall be expressed in double digits. Its specific label format is "valid to XXXX xx month" or "valid to XXXX XX month", can also be expressed in numbers and other symbols as "valid to XXXX.XX." Or "valid to XXXX/XX/XX" and so on.
the validity of biological products for preventive use shall be implemented in accordance with the registration standards approved by the State Food and Drug Administration, the validity period of biological products for therapeutic use shall be calculated from the date of distribution, and the validity period of other drugs shall be calculated from the date of production. If the validity period of the
is marked to the day, it shall be the day before the date of the date of the year, and if it is marked to the month, it shall be the previous month of the month of the year and month of the year.Article 31 of the
the names of pharmaceuticals labeled in the drug specifications and labels must comply with the principles of naming generic names and commodity names of medicines published by the State Food and Drug Administration and in accordance with the corresponding contents of the drug approval documents.
Article 32 the generic name of the drug shall be prominent and prominent, with the same font, font size and color, and in accordance with the following requirement
s:
(i) for the cross-section label must be marked prominently within one third of the upper range; No cursive, cursive and other hard-to-recognize fonts shall be selected, and no fonts shall be modified using italics, hollows, shadows, etc.;
(3) font colors shall be used in black or white, with a strong contrast to the corresponding light or dark background; and
(4) shall not be written in the same way except because of the limitations of packaging size. article 33
The name of a pharmaceutical commodity shall not be written in the same way as the generic name, its font and color shall not be more prominent and significant than the generic name, and its font shall not be greater than one-half of the font used in the generic name in terms of a single word area.
Article 34 The use of unregistered trademarks and other unregistered food products is prohibited in the drug specifications and labels.