As established in the Agreement for Innovation Promotion within the pharmaceutical sector, the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) approved 32 new drugs at the end of 2014. The authorization of these drugs will allow their implementation on treatments for many chronic non-communicable diseases, which are related to 60% of death causes in the Mexican population, such as diabetes and cancer.
Mikel Arriola, COFEPRIS Head Commissioner, said that 18 new therapies will be approved by the first quarter of 2015. These therapies will treat diseases such as gastrointestinal disorders, rheumatism, cancer and diabetes; of which the most anticipated is an orphan drug to treat multiple myeloma.
According with the European Union, orphan medicinal product (orphan drugs) are intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders affecting less than 5 per 10,000 citizens, and are not commonly developed by the pharmaceutical industry without incentives, as they would not generate sufficient return to justify the necessary investment.
Mikel Arriola said that Mexico was selected as a platform for global launch 4 of the 32 new molecules. Two of these are for diabetes, from which one of them called Jardianz; one for chronic obstructive pulmonary disease (COPD), called Ultibro-Breezhaler; and one for pulmonary hypertension, called Zependo.
El titular de COFEPRIS dijo que cuatro de las 32 moléculas nuevas seleccionaron a México como plataforma de lanzamiento global. De éstas, dos son para diabetes (una de las cuales llamada Jardianz), una para enfermedad pulmonar obstructiva crónica (EPOC) (denominada Ultibro-Breezhaler) y otra para hipertensión pulmonar (de nombre Zependo).
The 32 drugs endorsed by the health agency are new products and combinations of substances not previously existing in the domestic market. These new drugs are generic and from foreign manufacture.
This advance in the pharmacological field has been possible thanks to the Equivalence Agreements with the US Food and Drug Administration (FDA), Health Canada, Swissmedic, Australia, and the Mexican Accreditation Agency (EMA); as well by enabling the National Institutes of Health as Authorized Third Parties to properly implement clinical protocols.
Source: Secretaría de Salud (Mexico’s Ministry of Health), Europa.eu
