Colombia

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Industry support for a new regional regulator for Latin America and the Caribbean is cautious and experts warn that it could harm competitiveness of the region.

Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.

Regulators in Mexico, Colombia and Cuba have affirmed plans to create a new Latin American and Caribbean Medicines Agency.

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The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

Here’s the complete list of foreign firms that were included on an import alert because gloves they made or sold may have been “reprocessed, cleaned, or recycled and sold as new,” the US FDA says.

Gedeon Richter and Mithra have expanded their partnership on an in-development contraceptive, Estelle, to cover several Latin American territories on top of Europe and Russia.

Global free trade agreements are having a detrimental effect on savings that can be achieved by using generics and biosimilars across healthcare systems worldwide, according to a new IQVIA report hosted by the IGBA.

The agreement should help Colombia improve its HTA process and access to medicines there.

Latin American countries are continuing to pursue a strategy of jointly negotiating medicine prices to get a better deal on expensive medicines. However, manufacturers have expressed doubt that this is the best way forward.

Sanofi Consumer Healthcare is utilizing emerging digital technology to take a bigger slice of the Latin American OTC market. Through a partnership deal, e-commerce and delivery firm Rappi will promote and sell Sanofi's brands to consumers across seven Latin American markets. 

Gilead sought the US Trade Representative's intervention to halt sofosbuvir compulsory license, while Pfizer complained about Malaysia regulation requiring disclosure of prices throughout the pharmaceutical supply chain.

Countries in South America have negotiated lower prices for the immunosuppressant tacrolimus and have their sights on high-cost oncology treatments. However, they have slammed companies selling new hepatitis C treatments for their inflexibility.

A draft circular on pricing has raised the spectre of price controls being applied with little warning for companies, the Colombian research-based pharmaceutical industry has warned.

Colombia has been moved on to the USTR’s 301 Priority Watch List, in part because of a new pricing policy.

Colombia has been moved on to the USTR’s 301 Priority Watch List, in part because of a new pricing policy.

The pharmaceutical industry in Colombia is concerned that a new pricing decree could impact the regulatory process for new drugs.

Companies will face new therapeutic evaluations in Colombia to help determine the price of their new drugs.  

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