Regulatory document
Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/…
CDSCO · Information · India
Key facts
| Title | Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP |
|---|---|
| Issuer | Central Drugs Standard Control Organization |
| Source | CDSCO |
| Document type | Information |
| Country or region | India |
| Document | cdsco.gov.in |
| Issuer website | cdsco.gov.in |
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