Boosting access to biotech drugs
In December 2014 the Mexican Ministry of Health completed the regulatory framework for the registry of innovative biotechnology and biosimilar drugs, which are used for the treatment of chronic degenerative diseases such as cancer, diabetes, hypertension, asthma and arthritis.
Regulation 257, which will enter into force in early February 2015, establishes the guidelines, requirements and criteria that the Mexican Health Authority (COFEPRIS) will apply for the evaluation, approval and renewal of innovative biotechnology and biosimilar drugs.
In addition this regulation defines the criteria that COFEPRIS will apply during the registration process of the biotech drugs, the requirements for manufacturing process control, the procedure for the authorization of clinical trials and the specifications for the establishment of reference drugs.
Before applicants can submit their dossier to COFEPRIS for registration the New Molecule Committee and the Subcommittee on Evaluation of Biotechnology Products must review the available information and issue a report on whether there are technical data to prove the safety, quality and efficiency of the new biotech drug.
This new regulation encourages the registration of new biotech drugs, which already represent 35% of applications received by COFEPRIS.