Guidelines on “Similar Biologics: Regulatory requirements for Market Authorization in India” will be implemented from 15th September 2012.
The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.
The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.
The guidelines address the regulatory pathway regarding manufacturing process and quality aspects for similar biologics.
These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for similar biologics.
For further details visit
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0NA==
Recent Posts
Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23
Summary Short Description Strict regulatory protocols govern clinical investigations for medical devices. Central to this process are forms MD-22 and MD-23. Form MD-22 is an application to Central Lic..
Regulatory Challenges of SaMD: Navigating Global Standards and Compliance
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
The Future of SaMD: Emerging Trends and Innovations
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring...
Contact us
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.