BA/BE study applications have to be processed in 15 days: CDSCO
New Delhi: In order to streamline the applications process by various pharma companies, the CDSCO in its notice has recently mandated that BA/BE study applications will be processed have to be processed by the departments within 15 working days of receipt of the application,
The notice was issued for the information of all stakeholders by the BA/BE Division for Export, CDSCO.
In its notice, the authority stated that permission to conduct BA/BE study of New Drugs for export purpose is granted by Central Licensing Authority (CLA), as per the New Drugs and Clinical Trial Rules, 2019, in Form CT-07. Import Licence in Form CT-17 is also granted for import of study drug for this purpose, it pointed out.
" In order to further streamline the processing of such applications, it has been decided that such applications will be processed by CDSCO within 15 working days of receipt of the application," the notice by Dr V.G. Somani Drugs Controller General (India) stated.
BA/BE study are mandatory to be submitted by pharma companies to the CDSCO for its approval
Bioavailability (BA) refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
Bioequivalence (BE) of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutical equivalent test product and a reference product.
To check out the notice click on the following
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