The Central Drugs Standard Control Organization (CDSCO) has published a revised draft Guidance for Industry: Post Approval Changes in Biological Products: Quality Safety and Efficacy Document. This draft guidance document was published on February 28, 2024.
The document was prepared in consultation with stakeholders to align with international guidelines. It took into consideration WHO guidelines and current international practices followed by various regulatory agencies.
CDSCO has decided to invite suggestions/ comments/ objections from stakeholders on its draft guidance document. These may be submitted by April 13, 2024.
Interested stakeholders are requested to send their suggestions/ comments/ objections by email to biological@cdsco.nic.in and vaccine-bio@cdsco.nic.in
