Medicinal Products for Human Use: EMA's Highlights 2019
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The EMA has published the highlights for 2019 regarding medicinal products for human use.
The highlights include a short summary of relevant topics such as:
Overview of marketing authorizations in 2019
30 new APIs were recommended for approval,
3 accelerated assessments,
8 conditional marketing authorizations,
1 marketing authorization for the treatment of complicated and life-threatening influenza under exceptional conditions (these marketing authorizations are subject to specific post-authorization requirements / obligations and monitoring).
7 orphan medicines,
4 negative opinions,
12 withdrawn applications,
The selected marketing authorizations from the perspective of "important contributions to public health" include the cannabis product Epidyolex for the treatment of rare forms of childhood epilepsy. Epidyolex contains high-purity cannabidiol (CBD) as the active ingredient. It is the first CBD product to receive a positive decision in the centralized EU approval procedure.
"Ensuring integrity of clinical trial conduct and the manufacture and supply of medicines":
GCP deficiencies: In 2019, an application in the centralized EU marketing authorization procedure was withdrawn due to Good Clinical Practice (GCP) non-compliance.
Nitrosamines: In September 2019, the EMA initiated a review by marketing authorization holders for the prevention of the presence of nitrosamine contamination in medicinal products for human use. In connection with this review, the CHMP has requested marketing authorization holders of medicinal products with chemically manufactured APIs to evaluate their medicines with regard to the possible presence of nitrosamines on a risk-based approach and to test all risk products. The EMA and national regulatory authorities will continue to monitor the presence of nitrosamine impurities in medicines, also in cooperation with authorities outside the EU.
The section "Keeping medicines safe" contains a summary of the EMA's main pharmacovigilance activities (Important new safety advice) in 2019.