Number of medicinal products is steadily increasing, therefore safety of drugs, together with efficacy and quality, is the essential condition of positive assessment of the benefit-risk ratio of the medicinal product.

Clinical trials, which provide the base of evidence in drug approval process, do not describe all the issues of safe drug usage in the post-authorization environment. It is necessary to collect and properly analyze information on adverse drug reactions (ADRs) and perform adequate activities – these are the main goals of pharmacovigilance system. The stakeholders of the system are pharmaceutical companies, healthcare professionals and competent authorities – in Poland it is the Office for Registration, who takes the responsibility. Part of this role is the causality assessment of individual ADR reports from territory of Poland and assessing the information  collectively in order to identify if there is any new safety issue arising.

The process of accession to the European Community and required implementation of the European directives provided Polish competent authority tools, which allow performing pharmacovigilance activities and taking adequate decisions when the new safety concern is identified. Polish pharmaceutical law sets certain obligations to marketing authorization holders. Pharmaceutical company, which is planning submission of marketing authorization application is required to provide, as part of the application documentation, the description of  pharmacovigilance system within the company and, if required, Risk Management Plan. The aim of the document is to minimize the risk of therapy with the product.

Another important consequence of implementing European directives is the fact, that there will be only one renewal process and after that the marketing authorization will be issued for an unlimited period of time. In this new context, assessment of drug safety data will be the key element, when deciding if the medicinal product needs any special monitoring, what are the conditions of safe therapy with the product or is it necessary to suspend the marketing authorization. This kind of evaluation will also be performed by the Office for Registration of Medicinal Products.

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