Mexico Continues Reliance Strategy To Expand Drug Access

Mexico aims to speed up the registration of generics and biosimilars.

shortcut
Mexico Wants To Improve Registration Of Generics And Biosimilars • Source: Shutterstock

Mexico’s medicines regulator, COFEPRIS, says it is streamlining the registration of generic medicines and biosimilars by recognizing registration studies conducted in other countries. The move is part of Mexico’s shift towards greater regulatory reliance.

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

Brazilian Drug Price Increase Rates Hit Eight-Year Low

 

CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Brazil Consults On How To Price Advanced Therapies

 

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

England’s NICE Leads Global Effort On Surrogate Endpoints For Cost-Effectiveness

 

Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.

More from Geography

ICH Modernizes Stability Testing Guideline

 
• By 

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease