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PRAC July 2021 – Update on ongoing evaluation of COVID-19 vaccines, EMA advises on COVID-19 Vaccine Janssen and no evidence linking gene therapy Zynteglo to blood cancer

During its July 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded a safety signal of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) with COVID-19 vaccines Comirnaty and Spikevax and has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 vaccine Janssen.

Call for all sponsors to publish clinical trial results

The FAMHP reminds all sponsors they are obligated to publish the results of their clinical trials in the European Clinical Trials Database (EudraCT) within one year after the end of trial date (or six months for a paediatric trial). Publication on external sources or the transmission of reports to national competent authorities is not sufficient. The guideline applies retrospectively.

Limited availability of Bleomycine Sanofi 15,000 IU

The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.