The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021 for sponsors and applicants of clinical trials about the new Clinical Trial Regulation (CTR). The first information session will take place virtually on 23 September 2021 from 9 a.m. to 12:30 p.m.
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.
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.
The use of contraception after treatment with genotoxic medicines: add recommendations to patient information leaflets
The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.
FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).
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.
The FAMHP has once again renewed a number of measures in a new decision by the Chief Executive Officer of the FAMHP. This decision has once again been taken to avoid medicine shortages in the context of the coronavirus pandemic (COVID-19).
PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines
During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.
The European Medicines Agency (EMA) has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium.
During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.