Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines. 

Mexico Meds
Mexico to improve access to medicines with biosimilar regulatory strategy • Source: Shutterstock

Mexico’s regulator, Cofepris, wants to drive local production and development of biosimilar medicines to increase access through a new regulatory and operational framework for these products. The plans include the creation of several new bodies, including a new Council for National Pharmaceutical Development.

The announcement on 9 February by Cofepris head Alejandro Svarch Pérez follows recent moves to increase access to biosimilars and generics by recognizing registration studies conducted abroad that have been evaluated by World Health Organization-approved authorities with standards that are equal to or better than those of Cofepris

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Latin America

More from Geography