The guidelines for writing pharmacology-related Information on chemical drug instructions and labels was announced on March 21, 2023, by the Center for Drug Evaluation (CDE) for trial implementation and came into effect immediately. The guidelines aim to provide technical guidance to enterprises for writing accurate and standardized pharmaceutical information on drug instructions and labels.
Compared with the circular of “General Formats and Guidelines for Writing Instructions for Chemical Drugs and Biological Products” (No. 28, 2022) issued on May 20, 2022, the new guidelines focuses on the content, format, and terminology of drug instructions and labeling information.
The guidelines are applicable to chemical drugs and combination products of drugs and devices but not to biological products nor traditional Chinese medicine. The holder of the drug marketing license is responsible for providing accurate, standardized, concise, and understandable pharmaceutical information in drug instructions and labels. The guidelines recommend that the applicant summarizes and presents pharmaceutical information according to specific research data in the pharmaceutical application materials. For original research drugs that have been listed overseas, reference to the approval information of foreign regulatory bodies and making necessary transformations is necessary. For generic drugs, the pharmaceutical information should be consistent with the information of reference preparations, except for the contents that may differ according to relevant regulations.
The guidelines provide specific instructions for writing pharmaceutical information for prescription drugs. Drug names usually include generic names, trade names (if any), English names, and Chinese Pinyin. The generic name of a drug should conform to the principles for naming the generic name of a drug. Ingredients usually include active ingredient, chemical name, chemical structural formula (if applicable), molecular formula, molecular weight, and excipients in the preparation. The active ingredients should be listed in the package insert in the form of generic names. Prescription drugs containing multiple active ingredients can be expressed as “This product is a compound preparation, and its components are:”. The components are listed separately according to a preparation unit, and all the active ingredients and their dosages should be listed. For complex compound preparations such as electrolyte balanced salt solution and parenteral nutrition solution, it is recommended to list the active ingredients in the form of a prescription.
The guidelines also encourage whole life cycle management of instructions and labels related to traditional Chinese medicine. The relevant contents should be improved and revised in time in combination with the occurrence of post-marketing changes of drugs and the accumulation of information on drug use.
In addition to pharmaceutical information, drug packaging and labels also require accurate and standardized information. There are specific instructions for writing packaging and label information provided in the guidelines. Packaging information usually includes the name and packaging specification of the packaging material or packaging system that directly contacts the drug. The name of the packaging material should usually specify the material of the packaging material, and it is not recommended to simplify the writing as aluminum-plastic blister. The packaging specification should be expressed in accordance with the minimum preparation packaging unit.
The expiration date of the drug product shall be determined based on the stability test data. The term of validity shall be described in months, generally a multiple of 6 months, usually not less than 12 months. If storage after opening is involved, note that the storage time after opening should be covered within the validity period of the drug.
Other pharmaceutical information related to drug use may also include drug preparation, temporary storage, etc. For particularly complex reconstitution and dilution operations, separate instructions for use are recommended. Temporary storage conditions and allowable time limit shall be provided for temporary storage during drug use, including after drug preparation and drug loading of drug administration devices.
For OTC drugs, the content and format of pharmaceutical information in the instructions shall comply with the relevant provisions of the current laws and regulations and guidelines of China. Other related pharmaceutical information, such as drug preparation, device use, etc., is recommended to be expressed in a concise and understandable way.
Concerning the label design and content of medicines for children, special attention should be paid to the use risk of children. It is recommended to indicate the age limit of target children in the label to prevent child injury caused by misuse. The label should state “Keep this product out of the reach of children” to avoid accidental ingestion by children.
In summary, the Guidelines for Writing Pharmacology-Related Information on Chemical Drug Instructions and Labels provide technical guidance, with examples, for writing accurate and standardized pharmaceutical, packaging, and label information. It is essential to provide accurate and clear information to promote the correct use of drugs in clinics and ensure the safety of patients.
Compared with prescription drugs, the key difference of pharmaceutical information in non-prescription drug instructions lies in the description of [Components] and [Specifications]. Other items can be implemented with reference to this guideline. Non-prescription drug instructions guidelines are detailed in the “Notice on the issuance of non-prescription drug instructions specification rules” (State Food and Drug Administration Registration [2006] No. 540)
Further information
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