COFEPRIS decided to modify the Official Mexican Standard (NOM) 177 in order to facilitate the registration of generic and biosimilar medicines in Mexico. The announcement that was made on 28 September 2023 explained that COFEPRIS will start to recognize clinical studies conducted from outside countries, as long as the country qualification is higher than Mexico or certified as reference bodies by the World Health Organization (WHO).
This modification benefited both foreign manufacturers and local companies who obtained manufacturing and marketing licenses for pharmaceutical products. Mexico shows good initiative to streamline the local registration requirements and international standards. As the regulatory facilities are rapidly developing, this initiative may support the expansion and improve the therapeutic products demands from Mexico.
However, in the meantime, the clinical studies results conducted in the country are still required as the registration requirement for biosimilar medicines.
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