Besides working with COFEPRIS
, Emergo's office south of the border provides customers with Mexican Registration Holder representation, a service that allows manufacturers to maintain control over their medical device registration.
is the Mexican equivalent of the United States FDA.
LuViva has marketing approval from Health Canada, COFEPRIS
in Mexico, Ministry of Health in Kenya and the Singapore Health Sciences Authority.
Genzyme, a division of Sanofi (Euronext:SAN)(NYSE: SNY), announced on Tuesday the approval bye Mexico's national regulatory authority, COFEPRIS
, of Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
In addition to the tests conducted by Mexico's pharmaceutical-testing commission (Comision Federal para la Proteccion contra Riesgos Sanitarios, COFEPRIS
), Mexican inspectors should be allowed to visit Chinese laboratories to ensure that the certification process complies with international standards, said Alvarado.