India's CDSCO Pharmacovigilance released an updated guidance "Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products", Version 2 (dated 17 September 2024) provides a detailed framework for pharmaceutical companies and related authorities to ensure proper safety monitoring and risk management of pharmaceutical products. This guidance supports compliance with pharmacovigilance (PV) regulations to safeguard public health.
Pharmacovigilance (PV): PV is defined as the science and activities relating to the detection, collation, assessment, understanding and prevention of Adverse Event (AE) or any other drug related problem.
Marketing Authorization Holders (MAHs): MAHs refers to the manufacturer, marketer or the importer of the drug, who has valid manufacturing, marketing or import licence.
The objectives of this guidance are
Assist MAHs in accurate, efficient, and timely reporting of adverse events (AEs).
Establish a uniform Pharmacovigilance (PV) system at MAH organizations through:
Preparation and maintenance of the Pharmacovigilance System Master File.
Collection, processing, and reporting of Individual Case Safety Reports (ICSRs).
Preparation and submission of Periodic Safety Update Reports (PSURs).
Implementation of a Quality Management System (QMS).
Conducting audits and inspections of the PV system.
Preparation and submission of Risk Management Plans (RMPs).
The scope of this guidance covers Drugs, new drugs, and fixed-dose combinations, Biologics, including biosimilars and cell culture-based products, Radiopharmaceuticals & Phytopharmaceutical products.
The following Chapters are covered in this guidance
Chapter 1: Pharmacovigilance System Master File (PSMF): Discusses the requirement for maintaining a PSMF, which details the company’s pharmacovigilance system, its structure, and operations.
Chapter 2: Collection, Collation, Processing, and Reporting of Individual Case Safety Reports (ICSRs): Provides guidance on how MAHs should report adverse drug reactions, including timelines and standards for reporting.
Chapter 3: Preparation & Submission of Periodic Safety Update Report (PSUR): Details how to prepare and submit PSURs, which provide an assessment of the benefit-risk balance of a drug at defined intervals.
Chapter 4: Quality Management System (QMS) at Marketing Authorization Holder Organization: Outlines how MAHs should maintain a QMS to ensure continuous monitoring and improvement of pharmacovigilance activities.
Chapter 5: Audit & Inspection of Pharmacovigilance System: Discusses the processes for auditing and inspecting the pharmacovigilance systems at MAH organizations to ensure compliance with regulatory requirements.
Chapter 6: Submission of Risk Management Plan (RMP): Guides the preparation and submission of RMPs to mitigate identified risks associated with pharmaceutical products.
Additionally, the guidance covers the preparation of Risk Management Plans (RMPs) and the auditing of pharmacovigilance systems to enhance compliance with safety regulations. For more detailed References, click this link: India CDSCO Pharmacovigilance Guidance Document Version 2
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