약학회지

ISSN 0377-9556 (PRINT)
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Table. 1. References by countries used in the study
Laws, Regulations Guidelines, Reports
South Korea

Pharmaceutical Affairs Act (No. 19897)

Announcement of the 2024 Electronic Delivery of Drug Information (E-Labeling) Pilot Project (2024)

Japan

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and related regulations

Instructions for completing electronic leaflets for medical products (2021)

Singapore

Health Products Act 2007 (G.N. No. S 103/2021)

Health Products (Therapeutic Products) Regulations 2016 (No. S 329/2016)

Guidance on Electronic Labelling for Therapeutic Products (2021)

European Union

Directive 2001/83/EC

Electronic product information for human medicines in the EU : Key principles (2020)

United States

Code of Federal Regulations (CFR) Title 21, Part 201 Labeling

79 Federal Register 75506:‘Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products’(2014)

US Government Accountability Office (2013) Electronic drug labeling: No consensus on the advantages and disadvantages of its exclusive use.

Yakhak Hoeji 2024;68:239-51 https://doi.org/10.17480/psk.2024.68.4.239
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