Marketing Authorization Of Biological Product: An Overview. Evaluation And Ctd Filling Of Alefacept In Europe

      Аннотация: Biological medicinal products cover a diverse field. In the European Union, many of these are under the respon­sibility of the European Medicines Agency and are authorised via the centralised marketing authorisation procedure, such as products manufactured by biotechnology, or advanced therapy medicinal products. Naturally derived biological maybe nationally authorised in individual Member States, rather than through the pan European procedure. Due to the diverse nature of biological products, a number of specialised groups have been established within the Agency to supervise and coordinate activities related to these products. The regulation of follow-on biologics is a rising concern for the biotech industry since many biologics are approaching the end of their patent life, and as a result, will open the market for more affordable generics.

Ключевые слова: EU, EMA, Advanced Therapy Medicinal Products (ATMPs), Committee for Medicinal Products for Human Use (CHMP).