Transitional period planned for Regulation 257 on biotech drugs
Regulation 257 on biotechnology and biosimilar drugs, approved recently by the Mexican Health Authority (COFEPRIS), will enter into force in early February 2015. This regulation establishes a transitional plan for the renewal of health registrations of biotech drugs that were granted before the changes to the Regulations of Health Supplies, which were published in 2011, entered into force.
The transitional plan establishes that:
• COFEPRIS will classify the corresponding product as innovative or biosimilar.
• Renewal applications of innovative biotech drugs will not require the opinion of the Subcommittee on Evaluation of Biotechnology Products (SEPB).
• Renewal applications of biosimilar drugs require an opinion by SEPB stating the reference product so that applicants can carry out the corresponding studies.
This plan will apply to all renewal applications received before December 31, 2015.