ISSN 2383-9457 (ONLINE)
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. |