CDSCO has prepared draft guidance for Industry on Pharmacovigilance requirements on Human Vaccines, Version 2.0. Suggestions/comments/objections from stakeholders for draft guidance document will be solicited. They can be forwarded within 15 days from date of issuance of this notice, at - psur.drugs@cdsco.nic.in The suggestions/comments/objections received within the period of 15 days will be taken into consideration for finalization of draft guidance document.
CDSCO has prepared a draft guidance for Industry on Pharmacovigilance requirements on Human Vaccines, Version 2.0 in consultation with the AEFI Secretariat and IPC-PVPI to align with New Drugs and Clinical Trials Rules, 2019. It is decided to solicit suggestions/comments/objections from the stakeholders with regard to the draft guidance document. The suggestions/objections/comments can be forwarded with valid justification within 15 days from the date of issuance of this notice by email at - psur.drugs@cdsco.nic.in The suggestions/comments/objections received on the above email address with valid justification within the period of 15 days will be taken into consideration for the finalization of the draft guidance document