The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.
Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.
The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.
The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN). The public consultation will run from 28 July 2021 to 27 August 2021.
Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists
The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.
Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)
The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.
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.