| Domestic Industry Actively Engages in Multifaceted Activities to Solidify South Korea’s Status in the Global Pharma-Bio Sector
| Efforts Include Translating and Distributing the Latest FDA Guidelines and Sharing Clinical Trend Analyses for Industry-Wide Growth
| MFDS Collaborates with the Industry, Unveiling GPS Strategies to Elevate Global Standing
South Korea's status in the global pharma-bio arena is rising. According to the Ministry of Food and Drug Safety (MFDS) 2022 Clinical Trial Approval Status, South Korea's global clinical trial market share climbed from 8th in 2019 to 5th in 2022, showcasing a continuous upward trajectory.
The domestic industry is also making notable efforts to achieve world-class competitiveness. Rapidly translating and distributing the latest guidelines from global regulatory bodies, as well as sharing clinical trial trend analyses from CROs, are part of the industry’s active efforts to achieve collaborative growth.
Furthermore, the MFDS emphasizes the partnership between the regulatory agency and the industry for mutual growth and has announced the GPS strategy to solidify its status on the global stage, raising expectations for proactive collaboration.
■ JNPMEDI Distributes Free Korean Translations of Latest FDA Guidelines to Swiftly Respond to Global Regulations
Medical data platform company ▲JNPMEDI’s Global Research Center has distributed free Korean translations of the latest FDA guidelines published in March and May of this year.
JNPMEDI, a leader in the digital transformation of clinical trials, has swiftly updated and incorporated global regulatory policies and guidelines into its product designs. This distribution aims to provide domestic clinical stakeholders with quick and easy access to new global policies and guidelines.
The recently published FDA guidelines on 'Decentralized Clinical Trials for Drugs, Biological Products, and Devices' detail various recommendations for conducting DCTs, from design to remote trial activities, the use of digital health technologies (DHT), and the packaging and shipping of investigational products. Given the current domestic legal restrictions on telemedicine, drug delivery, and the absence of government guidelines on e-consent, the FDA's DCT guidelines could serve as critical reference points for establishing relevant legislation in South Korea.
Additionally, the 'Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations' guidelines published in March outline the requirements and recommendations of 21 CFR Part 11, allowing electronic records and signatures to be equivalent to paper records and handwritten signatures. The guidelines provide detailed Q&A on applying 21 CFR Part 11 to IT solutions used for managing electronic records and digital health technologies for remote data acquisition in clinical research.
Based on these guidelines, the expansion of IT solution use in clinical research is expected to increase, with regulatory bodies likely to enhance audit trail requirements to ensure data reliability and integrity. This underscores the growing necessity and utility of digital solutions. Pharmaceutical companies and CROs can drive efficiency in clinical trial operations, while clinical trial operators, such as healthcare professionals, can recognize the importance of digital solutions and gain new experiences.
| Domestic Industry Actively Engages in Multifaceted Activities to Solidify South Korea’s Status in the Global Pharma-Bio Sector
| Efforts Include Translating and Distributing the Latest FDA Guidelines and Sharing Clinical Trend Analyses for Industry-Wide Growth
| MFDS Collaborates with the Industry, Unveiling GPS Strategies to Elevate Global Standing
South Korea's status in the global pharma-bio arena is rising. According to the Ministry of Food and Drug Safety (MFDS) 2022 Clinical Trial Approval Status, South Korea's global clinical trial market share climbed from 8th in 2019 to 5th in 2022, showcasing a continuous upward trajectory.
The domestic industry is also making notable efforts to achieve world-class competitiveness. Rapidly translating and distributing the latest guidelines from global regulatory bodies, as well as sharing clinical trial trend analyses from CROs, are part of the industry’s active efforts to achieve collaborative growth.
Furthermore, the MFDS emphasizes the partnership between the regulatory agency and the industry for mutual growth and has announced the GPS strategy to solidify its status on the global stage, raising expectations for proactive collaboration.
■ JNPMEDI Distributes Free Korean Translations of Latest FDA Guidelines to Swiftly Respond to Global Regulations
Medical data platform company ▲JNPMEDI’s Global Research Center has distributed free Korean translations of the latest FDA guidelines published in March and May of this year.
JNPMEDI, a leader in the digital transformation of clinical trials, has swiftly updated and incorporated global regulatory policies and guidelines into its product designs. This distribution aims to provide domestic clinical stakeholders with quick and easy access to new global policies and guidelines.
The recently published FDA guidelines on 'Decentralized Clinical Trials for Drugs, Biological Products, and Devices' detail various recommendations for conducting DCTs, from design to remote trial activities, the use of digital health technologies (DHT), and the packaging and shipping of investigational products. Given the current domestic legal restrictions on telemedicine, drug delivery, and the absence of government guidelines on e-consent, the FDA's DCT guidelines could serve as critical reference points for establishing relevant legislation in South Korea.
Additionally, the 'Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations' guidelines published in March outline the requirements and recommendations of 21 CFR Part 11, allowing electronic records and signatures to be equivalent to paper records and handwritten signatures. The guidelines provide detailed Q&A on applying 21 CFR Part 11 to IT solutions used for managing electronic records and digital health technologies for remote data acquisition in clinical research.
Based on these guidelines, the expansion of IT solution use in clinical research is expected to increase, with regulatory bodies likely to enhance audit trail requirements to ensure data reliability and integrity. This underscores the growing necessity and utility of digital solutions. Pharmaceutical companies and CROs can drive efficiency in clinical trial operations, while clinical trial operators, such as healthcare professionals, can recognize the importance of digital solutions and gain new experiences.