Day: December 29, 2023

Data and information required for grant of permission to conduct bio availability and bioequivalence study of a new drug or investigational new drug

Document required for registration of bio availability and bioequivalence centre

Structure, content and format for clinical trial report

Data elements for reporting serious adverse events occurring in a clinical trial or bio availability or bioequivalence study

Data required to be submitted by an applicant for conduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength

Data to be submitted along with application to conduct clinical trial or import or manufacture of a Phytopharmaceutical drug in the country (India)

Data generated by Applicant:

Data required to be submitted by an applicant forconduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength

Data required to be submitted by an applicant for grant of permission to import or manufacture a new drug already approved in the country

Data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs for sale in the country