T/ZCHSP 010-2025 Active Group standards

T/ZCHSP 010-2025 Risk Level Guidelines for Drug Use during Pregnancy

Publish Date: 2025-09-25 Implement Date: 2025-10-25 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZCHSP 010-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Urban transportation facilities

ICS Name: Drugs

Publish Date: 2025-09-25

Implement Date: 2025-10-25

Scope

Determine the basis (including verification reports, statistical data, etc.) and reasons for the main technical requirements of local standards; local standard revision projects shall also list the main differences from the original standards. Terms and definitions section: Provide definitions of 12 terms related to pregnancy medication, teratogenicity, safety, pregnancy risk grading, pre-pregnancy preparation period, early pregnancy, middle pregnancy, late pregnancy, delivery period, low dosage, high dosage, and fertility. Basic requirements section: Clarify the basic requirements for the evaluation of pregnancy medication safety grades, including institutional qualifications and personnel requirements. The personnel requirements are based on the qualification requirements for medication counselors as referenced in the *Zhejiang Provincial Regulations on the Supervision and Management of the Use of Drugs and Medical Devices in Medical Institutions* (Decree No. 238 of the Zhejiang Provincial People's Government, September 19, 2007) and the *Notice on Issuing Five Standards for Pharmaceutical Outpatient Services in Medical Institutions* (Guo Wei Ban Yi Han [2021] No. 520). Evaluation process section: Clarify the content of information collection, evidence quality analysis, and preliminary grading in the evaluation of pregnancy medication safety grades. This content is based on the practical experience of various levels and types of medical institutions in Zhejiang Province that offer pregnancy medication counseling services. After establishing the pregnancy medication safety grades, the results are validated through follow-up data. The pregnancy safety grades are set with reference to the advantages and disadvantages of drug teratogenicity risk assessments conducted by the US FDA, Sweden's FASS, and Australia's ADEC. Based on practical experience, appendices such as the Drug Pregnancy Risk Grading Evaluation Table and the Continuous Improvement Process Table fo