EU regulatory requirements blog posts

06 December, 2017

6 regulatory questions you should ask when developing CATMPs

By Sanjay Jain

The recent development in cellular and molecular biotechnology, has resulted in the growth of a new segment of biological medicinal products and paved the way for Combined Advanced Therapy Medicinal Products (CATMPs). These products are regulated in the EU under the Advanced Therapy Medicinal Product (ATMP) Regulation and are defined as containing one or more medical devices as an integral part of the product. They offer ground-breaking new treatment and prevention opportunities for many diseases, dysfunctions and injuries to the various parts of the human body. 

Nevertheless, the development of these products also presents challenges in the form of precise requirements, regulations and associated guidelines. Here are 6 regulatory related questions you should ask when developing CATMPs. 

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