The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.
Over the past few weeks, more than three hundred thousand citizens have obtained iodine tablets from their pharmacies as a result of the conflict in Ukraine. The FAMHP has listed a few recommendations.
In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.
Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic
A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.
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.
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).
The European Commission is holding negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is presenting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for Janssen's (Johnson & Johnson) vaccine candidate. The Interministerial Conference (IMC) for Public Health has followed the advice. Belgium will buy the vaccine if a marketing authorisation is granted.
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 drug PF-06939926 for the treatment of Duchenne muscular dystrophy. The public consultation will run from 23 September 2020 to 23 October 2020.
Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.