Biologicals- Post Approval Changes
Biologicals- Post Approval Changes
The post approval changes are the changes made to biological products that have received an approval and to provide the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the products. After the approval, the applicant may make post approval changes, provided the changes are reported to the CDSCO under the appropriate categories.
As per the new amendment made by Central Drugs Standard Control Organisation (CDSCO) it is mandatory to file fresh new biological or manufacturing licenses for biological products in case of post approval changes. The CDSCO needs to be intimated in case of any post approval changes for biologicals.
According to a most recent guidance issued by the drug regulator, the applicants of the biological products who changes their product post approval should apply for new drug authorization, in case the change makes the product a new drug as per definition under rule 122E of the Drugs and Cosmetics Rules.
In case of change in manufacturing premises, the licensee would apply for the additional product permission to concerned state licensing authorities, zonal offices or sub-zonal offices and Central Licensing Approval Authority (CLAA) as per requirements of Drug & Cosmetics Act and Rules along with essential fees as per usual procedures.
It is mandatory for the applicants to file a new biological application in case of major quality changes and for filings like an additional manufacturing license for moderate quality changes with clear statements of change about procedural, qualitative and quantitative changes in comparative table form.
Similarly, the applicants should submit clear statements and evidences about effect of change on quality, stability, validation, animal toxicity and clinical (safety and efficacy) status of the product. “If, any waiver is expected or assumed in physicochemical characterization studies, stability studies, validation studies, pre-clinical (animal toxicity) studies & clinical studies, it shall be justified precisely proving the equivalence,” clarifies the amended guideline.
Reference
- Central Drug Standard Control Organization Directorate General of Health Services Office of Drugs Controller General (India), Biological Division. Checklist for Pre-screening of Applications for variations under Post approval changes as per CDSCO Guidance for Industry. Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/industry_download.jsp?num_id=MzY=. Accessed on- 11th June 2016.