The Indian guidance regarding pharmacovigilance system has given description about the preperation and submission of periodic safety update reports.
Introduction:
The Periodic Safety Update Report is a document for evaluation of the benefit-risk profile of a pharmaceutical product submitted by the MAH at defined time points as per Drugs and Cosmetics Act, 1940 and Rules thereunder during the post-marketing phase.
Objective:
This guidance document defines the recommended format, content and timeline of PSUR submission in conformity with Schedule “Y’ of the Drugs and Cosmetics Act, 1940 and Rules, 1945. PSURs are intended to be submitted to regulatory authorities and NCC-PvPI, IPC by the MAHs during the post-marketing phase, in order to monitor the safety and efficacy of pharmaceutical products marketed in India.
The main objective of a PSUR is to present a comprehensive, concise and critical analysis of new or emerging information on the risks and benefits of the pharmaceutical products in approved indications. The PSUR, is therefore, a tool for post-marketing evaluation at defined time points in the life cycle of a pharmaceutical product.
General principles
As per “Schedule Y” of Drugs and Cosmetics Act, 1940 and Rules, 1945 point (4) Post Marketing Surveillance-
(i) Subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed. The applicants shall furnish PSURs in order to-
(a) Report all the relevant new information from appropriate sources;
(b) Relate these data to patient exposure;
(c) Summarize the market authorization status in different countries and any significant variations related
to safety;
(d) Indicate whether changes should be made to product information document in order to optimize the use of the pharmaceutical product.
(ii) Ordinarily all dosage forms and formulations as well as indications for new drugs should be covered in one PSUR. Within the single PSUR separate presentations of data for different dosage forms, indications or separate population needs to be given.
(iii) All relevant clinical and non-clinical safety data should cover only the period of the report (interval data). The PSURs shall be submitted every six months for the first two years after approval of the drug is to the applicant. For the subsequent two years – the PSUR need to be submitted annually. The licensing authority may extend the total duration for submission of PSUR if it is considered necessary in the interest of public health. PSURSs due for a period must be submitted within 30 calendar days of the last day of the reporting period. However, all cases involving serious AEs/ADRs must be reported to the licensing authority within 15 days of initial receipt of the information by the applicant. If marketing of the new drug is delayed by the applicant after obtaining approval to the market, such data will have to be provided on the deferred basis beginning from the time the new drug is marketed.
(iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSUR.
