1. Subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in order to-

    

   1. Report all the relevant new information from appropriate sources;

       

   2. Relate these data to patient exposure;

       

   3. Summarize the market authorization status in different countries and any significant variations related to safety; and

       

   4. Indicate whether changes should be made to product information in

           order to optimize the use of the product.

 

2. 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 need to be given.

    

3. 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 granted to the applicant.  For subsequent two years – the PSURs need to be submitted annually. Licensing authority may extend the total duration of submission of PSURs if it is considered necessary in the interest of public health.  PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period. However, all cases involving serious unexpected adverse reactions 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 market, such data will have to be provided on the deferred basis beginning from the time the new drug is marketed.

    

4. New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.

    

5. A PSUR should be structured as follows:

    

6. A title page stating: Periodic safety update report for the product, applicant’s name, period covered by the report, date of approval of new drug, date of marketing of new drug and  date of reporting;

1. Introduction,

2. Current worldwide market authorization status,

3. Update of actions taken for safety reasons,

4. Changes to reference safety information,

5. Estimated patient exposure,

6. Presentation of individual case histories,

7. Studies,

8. Other information,

9. Overall safety evaluation,

10. Conclusion,

11. Appendix providing material relating to indications, dosing, pharmacology and other related information.

 

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