CDSCO has issued new guidance and checklist for submission of Biological application (vaccine) in order to accelerate the review process. This checklist will be utilized for review w.e.f January 1, 2011
Checklist:1. Permission for Conducting Clinical Trial (Phase I, II and III)
2. Global Clinical Trial
3. Market authorization / New Drug approval
4. Import License (Form 10)
5. Registration Certificate (Form 41)
6. Post approval Changes.
7. Test License for import of drugs under Form 11.
8. NOC for manufacturing of test batches for test and analysis under Form 29.
Click here for more information on the guidelines
