BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 and New Drugs and Clinical Trials Rules, 2019. 2. Detailed requirements and guidelines for conduct of nonclinical and clinical studies and approval of new drug are specified in SECOND SCHEDULE of New Drugs and Clinical Trials Rules, 2019.

Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...

6. However, accelerated approval should be used for a drug that represent significant advances over existing treatment or in case there is an unmet medical need for the indication for which the drug is intended, orphan drug for rare disease etc. in accordance with the provision prescribed under Second Schedule of ND& CT Rules, 2019. 7. ND & CT rules recognize the consideration of surrogate endpoin ...