Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.
The Indian Pharmacopoeia Commission and Central Drugs Standard Control Organization published the first version of the guidance in 2018. Later, an expert committee worked to revise the text, leading to the publication of a draft copy for consultation. Most of the final text is unchanged from the draft version, but the authorities have made some key revisions.
Major updates in the second version:- In the draft, Indian authorities proposed keeping an old requirement for marketing authorization holders (MAHs) to report non-serious adverse events within 30 calendar days of receiving information on the events. The final version extends the deadline to 90 calendar days.
- The final version also features changes to a subsection on document and record control, which now says, “MAHs shall maintain a logbook/excel spreadsheet/electronic data management tools for recording primary information received for every adverse event reported.”
- Indian authorities highlighted the changes to reporting timelines and record maintenance as two new things in the document. The list also includes updates to reflect the New Drugs and Clinical Trials Rules, 2019 and revised Schedule M of Drugs and Cosmetics Rules, 1945, the switch to the MedDRA dictionary for coding indications, and the removal of a Periodic Safety Update Report checklist.
- Another change is the addition of subsections on inspection procedures, findings and follow-up, responding to inspection findings, regulatory actions, and inspector training. The draft contained subheadings for regulatory actions and training inspectors, but the details were missing. Adding the information fills gaps that could help companies navigate the pharmacovigilance inspection process.
- Inspection procedures depend on the nature (routine/targeted) of the inspection and the conditions of inspection request,” the guidance states. “All the necessary PV documents should be submitted to the inspectors during inspection. When necessary, the inspectors may also request other documents related to the inspection, including job descriptions of PV personnel, products, and company-related information, etc.”
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Source Link: https://www.raps.org/News-and-Articles/News-Articles/2024/9/Asia-Pacific-Roundup-India-updates-pharmacovigilan.