NIS Considerations – South Korea
This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in South Korea. All sources of information are referenced and hyperlinked. Topics covered include:
- REGULATORY BODIES
- SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
- Regulatory Roadmap for Mandated NIS
- Regulatory Roadmap for ‘Other’ NIS
- REGULATORY SUBMISSIONS DOCUMENTS
- EC Submissions Document Checklist
- Which Documents Need to Be Translated?
- Who Is Responsible for What?
- STUDY CONDUCT CONSIDERATIONS
- APPLICABLE LEGISLATION AND GUIDELINES
- USEFUL LINKS
- Regulatory Requirements
- Study Conduct Considerations
- Best Practice Considerations