1. Pink Sheet
  2. >>Geography
  3. >>Latin America

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices

 
• By Francesca Bruce

El Salvador has approved a law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

El Salvador
El Salvador Strengthens Regulatory environment for medicines • Source: Shutterstock

El Salvador is to create the Superintendency for Health Regulation (SHR), a new regulatory body that will authorize medicines and medical devices, grant export and import licenses and set medicine prices. The move is expected to strengthen the national health system and protect patients, as well as make El Salvador a more competitive pharmaceutical market.

Earlier this month, the country’s legislative assembly passed the Health Regulation Superintendency bill, which will establish the new entity

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
Start Free Trial

Already a subscriber?

More from Latin America

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

Brazilian Drug Price Increase Rates Hit Eight-Year Low

 
• By Francesca Bruce

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

 
• By Francesca Bruce

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

 
• By Francesca Bruce

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

More from Geography

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.