Safety PSURs

Marketing authorisation holders are obliged to submit Periodic Safety Update Reports (PSURs) according to the frequencies outlined as follows ... 

Clearly, therefore, those involved in drug safety monitoring need to liase closely with both clinical research and medical information scientists. In addition, those responsible for clinical drug safety must undertake periodic safety update reports (PSURs) at predetermined intervals, in accordance with current International Conference on Harmonisation (ICH) guidelines. Such routine analyses can identify new safety signals as soon as they become detectable. 

When data received from a partner com-pany(ies) might contribute meaningfully to the safety analysis and influence any proposed or effected changes in the product information of the reporting MAH, these data should be included, with source indicated, and discussed in the PSUR, even if it is known that they are included in the PSUR of another MAH. 

In the past decade, there has been increased emphasis on drug safety, and more public visibility of safety problems. The volume of reports now exceeds 250000 spontaneous reports per year, and adverse events are highlighted in the medical press and also in the general media. The FDA has released extensive proposed new regulations for post-approval reporting that in part move to harmonise requirements with ICH recommendations for periodic safety update reports (PSURs)... 

Eor spontaneous reports of reactions occurring in Australia, serious reactions (whether expected or unexpected) should be reported immediately and in no case later than 15 calendar days of receipt of the report. Other reactions occurring in Australia should be reported on request or as line listings in a Periodic Safety Update Report (PSUR). 

The FDA requires MAHs to submit PSURs to present the worldwide safety experience of a medicinal product at defined times after authorization. It is usual for MAHs to prepare CCDS containing CSSI. Most MAHs have developed SOPs for worldwide collection, analysis, and reporting of adverse events. 

Guidelines on periodical safety update report (PSUR) introduced. Guidelines on stability for new formulations implemented. 

MAs are granted for five years in the first instance, after which a renewal is necessary. This requires submission of a review of all the product experience since the drug was first marketed. Essential parts of this review are the periodic safety update reports (PSURs), required every six months during the first two years of marketing, and annually thereafter. Normally, after the five-year renewal, further PSURs are required every five years. Under special circumstances more frequent PSURs may be required for products, which the authorities wish to keep under closer review. There is never any relaxation of the requirement for expedited reporting of serious, unexpected AEs. 

A key section of the PSUR is the overall safety evaluation. This is where any important newly identified or ongoing safety issues are identified and proposals made to address them. 

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