Study on patients’medicine instruction regulatory system in the European Union and the enlightenment
- VernacularTitle:欧盟患者药品说明书管理体系研究及启示
- Author:
Sihan YUAN
1
;
Rong JIANG
1
;
Yujie ZHENG
1
;
Haiqi LI
1
;
Yixuan CHEN
1
;
Rong SHAO
1
Author Information
1. Institute of Drug Regulatory Science，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
patients’ medicine instruction;
European Union;
medicine instruction;
readability;
medication safety
- From:
China Pharmacy
2025;36(3):269-274
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients’ medicine instructions in China. METHODS Through searching the official website of the European Medicines Agency （EMA） and related literature， the definition， basic nature， and content of patients’ medicine instructions in the European Union were introduced， and the characteristics of the management system of patients’ medicine instructions in the European Union were analyzed in terms of the management department， approval and change procedures， readability requirements and information accessibility requirements. At the same time， the pilot situation of patients’ medicine instructions in China， as well as problems in the paths of classification and management， readability of content， and information timeliness were analyzed to put forward suggestions. RESULTS & CONCLUSIONS European Union had a dedicated department for the management of medicine instructions； the approval and change procedures for patients’ medicine instructions were clear， the readability requirements were detailed， the readability verification program with patient participation was established， and multi-channel and timely information disclosure was adopted. It is recommended that China establish a mechanism to categorize and manage professionals’ and patients’ medicine instructions， guide multiple parties to participate in the design of patients’ medicine instructions and refine the readability requirements， and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.
