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KCE Reports 396C (2025)ATMPs (Advanced Therapy Medicinal Products) are complex drugs based on cells, genes or tissues. Currently, they are mainly developed and used to treat certain cancers or genetic disorders. Only a small number of ATMPs are currently commercialised by the industry and they are often very expensive, up to several million euros per treatment.

KCE Reports 381C (2024) Forecasts of future spending on medicines are currently based mainly on past spending and trends. However, this approach does not adequately predict the impact of very expensive emerging drugs, such as cell and gene therapies. To identify those products and prepare the system for their arrival, the pharmaceutical pipeline needs to be systematically monitored. This is known as horizon scanning. KCE has issued recommendations to better predict future spending on pharmaceuticals, with particular emphasis on horizon scanning.

KCE Reports 356C (2022)

KCE Reports 347C (2021) To obtain marketing authorisation for the European market, any new product must provide evidence of its quality, safety and efficacy. For high-risk medical devices (e.g. implants), the requirements are less strict.