Periodic safety update report (psur) worldwide update: a review

In the rapidly developing era, Pharmacovigilance plays an important role in the healthcare system to put necessary brakes and obtains valuable additional information, building up the scientific data contained in the original report and making it more informative.As we all know that the regulatory agencies like EMA, USFDA, CDSCO etc. are very stringent in approving the drugs, They have framed several rules and imposed strict timelines for reporting the necessary documents pertaining to drugs. Alongwith the agencies the PvPI Programme, UPPSALA monitoring center(UMC) collaborated with WHO play important role in adverse event reporting. This review brief several aspects of PSUR in different countries, necessary processes and format in which it needs to be submitted, pitfalls and ways to overcome such situations have been discussed in brief. Therefore, it is the collective responsibility of both Regulatory agencies and the drug companies to ensure a good quality PSUR is produced with its benefits outweighing the risk of the drug for the suffering human population.