NIS Considerations – Mexico
This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Mexico. All sources of information are referenced and hyperlinked. Topics covered include:
- REGULATORY BODIES
- SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
- REGULATORY SUBMISSIONS DOCUMENTS
- Regulatory 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
- Data Privacy Considerations
- Study Conduct Considerations
- Best Practice Considerations
- ANNEX 1: TEMPLATE COVER LETTER