Biologics (Schedule D drugs) - Templates - Applications and Submissions - Drugs and Health Products

Blank Certified Product Information Document - Biologicals

Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D Drugs)) Template in the CTD Format

Blank Quality Information Summary - Biologicals (QIS-B) Templates

• Blank QIS-B template
• QIS-B Part 2-Blood
• QIS-B Part 2-rDNA/MAbs
• QIS-B Part 2-General
• QIS-B Part 2-Vaccines
• QIS-B Part 3-Biological product lines
• QIS-B Part 4-Biological product lines

Additional Resources

• Draft Help Notes for Completing the Electronic Quality Information Summary- Biologicals (QIS-B) and Certified Product Information Document - Biologicals (CPID-B)Templates
• Sample Template with Examples and Specific Notes Regarding the Preparation of the Comprehensive Summary- Chemistry and Manufacturing for Schedule D Biological Products of Recombinant DNA Origin (CS (CM-rDNA)