In January, the format of periodic safety update reports (PSURs) – which are mandated, analyses of the safety of approved drugs designed to track post-market changes to risk-benefit profiles – was revised and expanded as part of an overhaul of Europe's pharmacovigilance legislation initiated in 2010.
The changes mean drugmakers must use the Periodic Benefit Risk Evaluation Report (PBRER) format recommended by ICH E2C(R2) which, unlike the previous PSUR model, require a risk-based evaluation a drug’s health benefits as well as its safety profile.
A spokesman for the European Federation of Pharmaceutical Industries and Associations (EFPIA) told in-Pharmatechnologist the PBRER format is completely different to the “old” PSURs adding that the changes have created extra work for some firms that operate in multiple markets.
“It is EFPIA`s understanding that most non-EU countries will accept the PBRER format but there are some which will not, for example, India where as such there is the added burden that companies operating outside the EU will need to continue to run two processes for periodic report production.”
He also suggested the new format requires that drugmakers undertake more cross functional working, implement new processes and procedures and apply different skill sets, particularly when it comes to writing detailed drug benefit risk assessments.
Improvement
But despite the additional compliance burden, EFPIA says that adoption of the new format has had a positive impact in the three months since it was implemented, particularly from a data analysis standpoint.
“Overall it is a more complicated report to prepare for those reasons but, nevertheless, it is a definite improvement over the old style PSUR, is less of a “data – dump” and much more evaluative and interpretative.”
This interpretation will be welcome news for the EMA which told this publication last week that: “Overall there will be fewer submissions of PSURs in the EU but when they are submitted the documents will be more robust. The Commission’s 2008 legal proposal was accompanied by an impact assessment that demonstrated resource savings for the industry from the proposals for PSURs.
“The full benefit in terms of both efficiency gains and resources will only be fully realised after a few years of operation of the legislation."