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.
Report to all licensees or potential future licensees for drugs for human use: as of January 1, 2019, every file for acquisition of a license to market a drug for human use must be submitted in eCTD format.
The patient is one of the most important partners for the Federal Agency for Medicines and Health Products (FAMHP). In response to this, two symposia have already been organized regarding working with and for the patient.
As of 1 January 2019, the holders of a marketing authorisation (MA) must use the OTC version of the QRD template for drugs delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946.
The FAMHP wants to notify ophthalmologists and patients of a safety report from the American government, the Food and Drug Administration (FDA) on the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics. At this time there is no information that the ocular implant was also distributed in Belgium.
The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified ChAd155-RSV vaccine from the company GlaxoSmithKline Biologicals. The purpose of this trial is to provide critical information on the safety, reactogenicity and immunogenicity profile of the ChAd155-RSV vaccine in infants, as well as on the risk of vaccine-induced enhanced RSV disease after vaccination. The public consultation runs from 26 November 2018 to 26 December 2018 inclusive.
The campaign will run from the 19th to the 23rd of November and is part of an awareness week of 32 drug authorities from the EU, South America, the Middle East and Australia.
Submission of dossiers and documents to the Research and Development Division (human use) of the FAMHP via the CESP is compulsory since 1 October 2018. Today, the FAMHP publishes version 1.2 of the guidance.
