Regulatory Affairs in Latin America
In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in May 2013, for the treatment of COPD, Mexico was the first country worldwide to approve the drug for COPD + asthma simultaneously.
This was a possibility regulatorily, and practically times were so short, (the process took 18 months less than what it would have normally taken) thanks to the Agreement for Innovation, effort of the regulatory authority to promote access of new innovative drugs to the local Mexican market.
Just a couple of days after the product was approved in Mexico, the European Commission, following evaluation by the European Medicines Agency (EMA), granted marketing authorization for the drug for both indications in 31 European countries.
The drug product, developed by…
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