The proof of safety and efficacy of innovative specific biopharmaceuticals according to the specifications of the Chinese National Medical Products Administration (NMPA, Chinese: 国家药品监督管理局) are subject to the requirements for clinical trials according to the regulations of the German Medicines Act and approval by the European Medicines Agency (EMA) before they can be transferred to the European market. The exact analysis of the existing work was subject of intensive and harmonious discussions before the conception of a clinical trial in Europe can begin.
We were invited to enable excellent scientific experts to start their clinical studies in Europe in 2 spin-offs from a very renowned Chinese university and supported them with the first operative project phases.
Of the new drugs coming onto the market, one in four costs more than € 100,000 per year.
The analysis of the benefit assessment according to the Drug Market Restructuring Act (AMNOG) has been in place since 2011. The fifth AMNOG Report from 2019 discusses the extent to which the high annual therapy costs of newly approved active substances can be further taken over by the insured community. In addition to data on survival chances, pharmaceutical companies are required to present high-quality data on patients‘ quality of life for all indications in order to assess the additional benefit.
This ongoing development of the benefit assessment by the authorities, G-BA and IQWiG, related to this endpoint calls for the design and conduct of clinical trials with precisely fitting and objective endpoints. This is one of our main strengths.
© 2019 MEDIACC GmbH