Data and information required for grant of permission to conduct bio availability and bioequivalence study of a new drug or investigational new drug
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
Animal Toxicology studies as per the CDSCO Guidance
General Principles: Toxicity studies should comply with the norms of Good Laboratory Practices (GLP). Briefly, these studies should be performed by suitably trained and qualified staff employing properly calibrated and standardized equipment of adequate size and capacity. Studies should be done as per written protocols with modifications (if any) verifiable retrospectively. Standard operating procedures (SOPs) […]
Accelerated approval process
In such case, the approval of the new drug may be based on data generated in clinical trial where surrogate endpoint shall be considered rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint. These should be measurable earlier than irreversible […]
Requirements and guidelines for permission to import or manufacture of new drug
Application for permission to import or manufacture new drug for sale or to undertake clinical trials under these Rules shall be made to the Central Licencing Authority accompanied with following data in accordance with the Table 1 or Table 2 or Table 3 or Table 4 of the Second Schedule as the case may be, […]
