Certification of quality and pre-clinical data of MukoCell by the EMA
The quality and pre-clinical data of our lead product MukoCell have been certified by the European Medicines Agency (EMA). The Certification procedure follows the scientific and technical requirements necessary to facilitate a future MAA. The Certification confirms that the data submitted for an ATMP meet the same scientific and technical standards that apply to current regulation of other pharmaceutical and biotechnology products, including among others requirements regarding GMP, GCP, and stability.
Advanced therapy medicinal products (ATMPs) are at the forefront of biotechnology and medical innovation. Because of their novelty and complexity, evaluating the quality, safety, and efficacy of ATMPs often requires the development of alternative approaches that go beyond what is needed for conventional medicines. For example, testing the stability of a cell therapy product containing living cells derived from the patient’s body requires a fundamentally different methodology from testing traditional pharmaceuticals. In response to these challenges the European Regulation 1394/2007 provided a consolidated framework for this innovative class of products, including a procedure allowing small and medium-sized companies to voluntarily apply for the Certification of the pharmaceutical quality and the pre-clinical data of an advanced therapy product.
A Certificate issued by the European Medicines Agency (EMA) is based on the evaluation by the members of its Committee for Advanced Therapies (CAT). The CAT is a multidisciplinary committee bringing together several of the best available European experts to assess the quality, safety, and efficacy of advanced therapy products.
For more information on the Certification procedure, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000300.jsp&mid=WC0b01ac058007f4bd