Annual Report 2017
Database for clinical trials
New database for clinical trials in Belgium
In 2017, the 460 employees of the FAMHP closed more than 8,000 applications for marketing authorisation for medicines, carried out no less than 2,200 inspections and investigations, analysed more than 10,000 reports of adverse effects, reactions and incidents, and answered more than 250 press questions.
The European Medicines Agency (EMA) is conducting a review of the possible health effects in patients who may have taken certain lots of valsartan medicines containing an impurity called NDMA. This impurity was found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.
The Federal Agency for Medicines and Health Products (FAMHP) wants to get a better view of all upcoming new MRPs (Mutual Recognition Procedures), DCPs (Decentralised Procedures) as well as of all RMS switches (Reference Member State) resulting from Brexit. Marketing authorisation holders are asked to provide the FAMHP with the necessary information as well as the information regarding the sites for which the UK is actually responsible.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified hepatitis B vaccines from the company GlaxoSmithKline Biologicals. The purpose of this trial is to evaluate the safety, the immunogenicity and the efficacy of hepatitis B candidate vaccines in adult patients with chronic hepatitis B. The public consultation runs from 24 July 2018 to 23 August 2018 inclusive.
On 10 April 2018, the FAMHP launched a call for applications for the e-PIL pilot project, namely the project concerning the electronic Patient Information Leaflet. The effectiveness of the pilot project, or, in other words, the outcome of providing patient information in an electronic leaflet, will be studied using online surveys. The surveys will take place at the project’s launch, after 1 year, and after 2 years.
Patient participation throughout the development cycle of a medicinal product
During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
The results for 2017 confirm the trends of previous years with a reduced use of -7.4% mg active substance/kg biomass compared to last year. This is the biggest annual drop since 2011. Compared to the reference year 2011 it represents a total decrease of -25.9%.