Drug instructions to be provided via QR codes, URLs in S.Korea
The Ministry of Food and Drug Safety revises its risk management plan guidelines
By Mar 31, 2023 (Gmt+09:00)
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South Korea's the Ministry of Food and Drug Safety announced on Friday that it had revised the "Risk Management Plan (RMP) Guidelines" to allow for patient and professional instructions, which are provided as paper documents for drugs subject to risk management such as new drugs and rare drugs, to also be provided in electronic forms such as QR codes and URLs.
Introduced in 2015, the RMP is a system designed to mitigate the risks of pharmaceuticals by using patient and professional instructions for the safe use of pharmaceuticals.
As a result, pharmaceutical companies can now include QR codes or URLs on their product containers and packaging, enabling the distribution of "electronic drug instructions."
The ministry plans to pilot-test this initiative for formulations such as inhalers, which require precise guidance on the method of use and precautions because patients directly administer them, and will review additional improvements and industry support measures.
The revised guidelines also include plans to use "pregnancy contraindication pictograms" on the packaging of drugs requiring caution during pregnancy, as well as templates and operational standards for submitting RMP summaries.
The Ministry of Food and Drug Safety said it pushed for the revision to help patients and medical professionals quickly verify the latest information on drugs subject to risk management.
Write to Ji-Hyun Lee at bluesky@hankyung.com