PSUR and Risk Management

PSUR AND RISK MANAGEMENT

The ‘Guideline on risk management systems for medicinal products for human use’ from the EMEA, adopted in November 2005, clearly states that risk management plan (RMP) and its updates should be submitted at the same time as the PSURs unless other requirements have been laid down as a condition of the marketing authorisation. This RMP is now requested from health authorities for all new appli-cations. In general, safety issues should be identified at early stages in the development of a compound, and these issues be approached in a RMP. This RMP can then propose different actions to counteract or better understand these issues: education (physicians, patients, sales representatives etc.), step-wise market approach, use of utilisation and/or safety databases, specific studies targeting defined issues and so on. The RMP will serve as a guiding document, and assess-ment of the plan will be reported in the PSUR. The PSUR is thus now the document in which all the available information on safety of a given product is gathered from all sources, such as clinical trials, observational studies, spontaneous reports and also pre-clinical experiments, and put into perspective. The consistency of a potential signal/issue across all the sources is of very high value. The PSUR will help in that analysis because it is a unique document assem-bling all these information from multiple sources.