Regulators In Mexico, Chile And Colombia Take Steps Towards Regulatory Harmonization

Medicines regulators from the Pacific Alliance have taken a step towards greater regional regulatory harmonization in a bid to make registration of medicines faster.

Pacific Alliance
Regulators From The Pacific Alliance Aim For More Harmonization • Source: Shutterstock

Regulators from the Pacific Alliance in Mexico, Colombia and Chile – COFEPRIS, INVIMA and ISP respectively – have taken a step towards greater regulatory harmonization and have signed an agreement that they say will speed up the registration process for medicines.

At a meeting in Medellin, Colombia, the three regulators also set up a permanent technical team, the aim of which...

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

New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

 

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Argentina Speeds Up Market Access Process

 

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

More from Geography

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.