Periodic Safety Update Report (PSURs)

Periodic Safety Update Report (PSURs): Important Considerations


Periodic safety update reports (PSUR) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug. Periodic safety update reports are an effective mode of risk communication to the regulatory authorities and an important indicator for the requirement of risk management strategies.

Periodic safety updates reports: The procedure as per the “New Drugs and Clinical Trials Rules, 2019”

The applicant has to provide PSURs to report all relevant new information from appropriate sources and relate the data to patient exposure. The market authorisation status in different countries and any significant safety variations observed should be summarised. The applicant has to indicate whether alterations would be made to product information in order to optimise the use of product. All dosage forms and formulations as well as indications for new drugs can be covered under one periodic safety update report. Within the single PSURs data for different dosage forms, indications or separate population have to be mentioned separately. All pertinent clinical as well as non-clinical safety data should be covered only for the period of the report.

Periodic safety update reports (PSURs): Submission

After approval of the drug is granted, for the initial two years, PSURs should be submitted every six months. For the subsequent two years, PSURs have to be submitted yearly. If deemed necessary (with regards to public health) by the central licencing authority, the total duration of submission can be extended. Periodic safety update reports which are due for a certain time frame should be submitted within thirty calendar days of the last day of the reporting period. An exception to this are cases involving serious unexpected adverse reactions; such cases must be reported to the licencing authority within fifteen days of initial receipt of the information by the applicant. The PSUR should be structured as specified in the fifth schedule (Post market assessment) of the New Drugs and Clinical Trials Rules, 2019.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).


Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

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