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Revised pharmacovigilance guidance for human vaccines open for public consultation

Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice's issuance

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Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance

On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines” was released for public consultation by Central Drug Standard Control Organisation (CDSCO). This update aims to align the guidance with the New Drugs and Clinical Trials Rules, 2019, and has been developed in collaboration with the AEFI Secretariat and IPC-PVPI.

According to the statement, the stakeholders are encouraged to submit their suggestions, comments, and objections regarding the draft document within 15 days from the notice’s issuance.

The statement further adds that the feedback, along with valid justifications, should be emailed to [email protected]. All inputs received within this period will be considered in the finalisation of the guidance document, 

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