The Korea Food and Drug Administration (KFDA) and the Center for Regulatory Science of Advanced Biopharmaceuticals have published a guide to enhance the usability of the long-term tracking system for advanced biopharmaceuticals. This initiative aims to alleviate the operational and cost burdens on the industry, fostering an environment conducive to the development of new advanced biopharmaceuticals.
According to the KFDA on June 26, the guide, titled 'eCRF Guide,' was developed and distributed in collaboration with the center to improve user convenience for the electronic case report form (eCRF) integrated into the long-term tracking system for advanced biopharmaceuticals.
Advanced biopharmaceuticals require long-term monitoring of adverse events to ensure patient safety. Consequently, the eCRF system is utilized for the efficient execution of long-term tracking studies.
However, the industry has faced challenges in establishing eCRF systems due to the complexity of the design process and a lack of specialized knowledge, leading many to outsource to external organizations. This has resulted in ongoing concerns regarding cost burdens and operational inefficiencies.
In response to these industry challenges, the KFDA created this guide as part of its '50 Key Tasks for Food and Drug Safety.' The guide is designed to enhance accessibility for the industry by presenting eCRF utilization and design methods in an easily understandable manner.
The guide includes an overview of the long-term tracking system and eCRF operational framework, instructions for setting permissions and entering essential information by project, and guidelines for eCRF design, including item collection, adverse event coding, and concomitant medication coding.
A KFDA official stated, "We will continue to pursue regulatory improvements to support industry growth."
Industry representatives expressed optimism regarding the KFDA's eCRF guide, stating it is expected to reduce compliance costs and enhance operational efficiency for developers and contract organizations.
According to the KFDA on June 26, the guide, titled 'eCRF Guide,' was developed and distributed in collaboration with the center to improve user convenience for the electronic case report form (eCRF) integrated into the long-term tracking system for advanced biopharmaceuticals.
Advanced biopharmaceuticals require long-term monitoring of adverse events to ensure patient safety. Consequently, the eCRF system is utilized for the efficient execution of long-term tracking studies.
However, the industry has faced challenges in establishing eCRF systems due to the complexity of the design process and a lack of specialized knowledge, leading many to outsource to external organizations. This has resulted in ongoing concerns regarding cost burdens and operational inefficiencies.
In response to these industry challenges, the KFDA created this guide as part of its '50 Key Tasks for Food and Drug Safety.' The guide is designed to enhance accessibility for the industry by presenting eCRF utilization and design methods in an easily understandable manner.
The guide includes an overview of the long-term tracking system and eCRF operational framework, instructions for setting permissions and entering essential information by project, and guidelines for eCRF design, including item collection, adverse event coding, and concomitant medication coding.
A KFDA official stated, "We will continue to pursue regulatory improvements to support industry growth."
Industry representatives expressed optimism regarding the KFDA's eCRF guide, stating it is expected to reduce compliance costs and enhance operational efficiency for developers and contract organizations.
* This article has been translated by AI.
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