Data and information required for grant of permission to conduct bio availability and bioequivalence study of a new drug or investigational new drug
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 to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs for sale in the country
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 […]
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, […]
