As a result of changes to the PSUR guidelines in July 2012, the way we write all PSURs will be affected. These changes put more emphasis on risk-benefit, and introduce measures that should help streamline the writing of safety documents.
The good pharmacovigilance practice (GVP) guidelines came into effect in July 2012. The guidelines bring together a set of measures drawn up to facilitate the performance of Pharmacovigilance (PV) in the European Union (EU). The GVP guidelines are divided into 16 modules, each covering a major process in PV. Module VII discusses changes to the format and content of the PSUR.
What is the purpose of this new legislation?
A key aim of the PV legislation is to change the emphasis of the PSUR from a detailed presentation of individual case reports, to an evaluation of the risk benefit balance of a product. The major changes to the content of the PSUR are:
What improvements have been made?
The PSUR now has a modular format, which is intended to maximise efficiencies between different document types, since the same modules can be used in different documents.
Are there new timelines for submission?
PSURs with a submission date from Jan 2013 onwards should be in the new format. To accommodate the additional effort required to produce a PSUR in the new format, the submission timelines (post data lock point) have been amended.
What other changes have been made?
Finally, there is no longer a routine requirement for PSURs for generic, well established, homeopathic and herbal products; however, PSURs may be required for such products if a risk is identified or if there is a lack of information. The European Medicines Agency (EMA) will generate a list of EU reference dates and frequency of submission, including products and substances for which PSURs are required. This list will be displayed on the EMA web-portal and is expected to be updated monthly. Each marketing authorisation holder has the responsibility to check the web-portal for any updates.
About Medical Writing at ICON:
ICON provides an established medical writing service that has the experience, organisation and global resource capacity to support the full spectrum of medical writing projects during the development and post approval phases. As specialists in the provision of safety documents, ICON medical writers have the expertise to ensure a successful transition to all requirements of the developing regulatory environment.