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Annual report on the donation of human body material: increase in the declarations of explicit content and reduction in opposition

In Belgium, each individual, after their death, is presumed to be a potential donor. Since 2020, as well as organ donation, any Belgian citizen has had the option to express their will, explicit consent or opposition to the post-mortem donation of human body material like skin, cartilage, tendons or heart values for transplantation, the manufacture of medicines (advanced therapies) and for scientific research.

EMA warns against use of unproven cell therapies

The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) advises patients and citizens not to use unregulated cell therapies, which may be unsafe or ineffective.

COVID-19: electronic files submission

Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.

The law on allogenic ATMPs: important progress in the development of new innovative treatments

The law on allogenic ATMPs dated 30 October 2018 changes various elements in the law dated 19 December 2008 regarding human tissue products (HTP) with the intention of medical application on humans or for scientific research.

New Royal Decree on biobanks

The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018.

Survey of external satisfaction

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.

Notification en ligne des incidents et réactions indésirables graves liés au sang et aux composants sanguins

L’AFMPS a mis en place une procédure électronique qui permet aux personnes de contact « hémovigilance » des établissements de transfusion sanguine et des hôpitaux de notifier plus facilement les incidents et réactions indésirables graves qui surviennent chez les donneurs ou les receveurs de sang et de composants sanguins. Ce système permet une gestion plus efficace des données et une gestion plus rapide du suivi.

Journée mondiale du donneur de sang : 14 juin 2011

Le 14 juin, comme chaque année, c’est la Journée mondiale du donneur de sang. Cette journée a été officiellement créée en 2004 afin de demander que l’on accorde davantage d’attention au don de sang, de plasma et de plaquettes, et pour remercier tous les donneurs de sang, fidèles et nouveaux, qui ne cessent de donner du sang de façon désintéressée.

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