International practice and experience insights of electronic drug instructions
- VernacularTitle:电子药品说明书的国际实践及经验启示
- Author:
Yujie ZHENG
1
;
Rong JIANG
1
;
Yixuan CHEN
1
;
Haiqi LI
1
;
Sihan YUAN
1
;
Rong SHAO
1
Author Information
1. Institute of Drug Regulatory Sciences，China Pharmaceutical University/NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
drug instructions;
electronic instructions
- From:
China Pharmacy
2024;35(17):2061-2067
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the practices of electronic drug instructions in the European Union （EU）， the United States （US） and Japan， so as to provide references for promoting electronic drug instructions under Chinese existing regulatory systems. METHODS By searching the official websites of FDA， European Medicines Agency （EMA） and Pharmaceuticals and Medical Devices Agency （PMDA）， as well as relevant literature， the practice and system of electronic drug instructions in different countries/regions were compared and analyzed. The problems of regulatory system， accessibility form and management system of electronic drug instructions in China were analyzed to put forward the suggestions. RESULT ＆＆ CONCLUSIONS The EU， the US and Japan had established relevant laws for the implementation of electronic drug instructions， issued guidance to specify management requirements and work processes， and set up information platforms to standardize data requirements and enrich search channels. In contrast， the practice of electronic drug instructions in China is still in its infancy， the implementation of electronic drug instructions in China still lacks legislative support， and its accessibility form and future regulatory system need to be further explored. It is suggested to take the opportunity to carry out the pilot reforms of the age-friendly and barrier-free environment for drug instructions in China， improve the regulatory system of electronic drug instructions， promote the readability of drug instructions by exploring the accessibility form of electronic drug instructions in stages， establish and improve the regulatory system of electronic drug instructions， actively build an electronic information platform for it， and promote the development and implementation of electronic drug instructions.
