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Ibero-American biotech regs collaboration to be extended to ATMPs

This article was originally published in Clinica

Executive Summary

A collaboration between Latin American states, Spain and Portugal to strengthen the regulation of the pharmaceuticals sector in the Americas is to be extended to encompass "advanced therapies", in a move that will impinge on the medical technology sector. Following the 7th summit of Ibero-American Medicinal Competent Authorities (EAMI), held in Cancún, Mexico, at the end of October, a two-year workplan has been drawn up, featuring the creation of four technical working groups, including one on advanced therapy medicinal products (ATMPs), which encompass regenerative medicine. It will be headed by the Spanish medicines and healthcare products regulatory agency (AEMPS). The implementation of the workplan will be reviewed at the next EAMI summit, due to take place in Madrid in 2010. Spain is in the process of establishing a general directorate for advanced therapies and transplants (see Clinica No 1325, p 9).

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