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
Stability testing of new drugs
Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity and light, and to establish shelf life for the formulation and recommended storage conditions. Stability studies should include testing of those attributes […]
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) […]
Requirements for drug approval with new claims
In case a drug already approved by the Central Licencing Authority for certain claims, which is now proposed to be clinically tried or marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration or novel drug delivery system (NDDS), the requirements of data and information […]
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 […]