Regulatory Focus™ > News Articles > Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

Posted 20 September 2016 | By Zachary Brennan 

Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told Focus in an exclusive interview.

Rafael Pérez Cristiá, director general of CECMED, who oversees 300 staffers, said that as relations between the two countries continue to normalize, discussions and negotiations have not only been ongoing to bring new and generic products from the US to Cuba, but to begin performing clinical trials in the US on Cuba’s homemade lung cancer treatment and another drug to treat diabetic foot ulcers, known in Cuba as heberprot-p.

“Now, many US companies are trying to enter the Cuban market,” Cristiá told Focus. “What a pity and shame that this embargo lingered for so long.”

Currently, more than 60% of pharmaceuticals are produced locally in Cuba by 31 different companies at 64 manufacturing sites and a workforce of more than 20,000, with the rest of the market comprised of pharmaceuticals from multi-national companies that do not have headquarters in the US, including AstraZeneca, Roche and Germany’s Merck, as well as others from Latin America.

One of the most recently introduced foreign products to Cuba is Roche’s breast cancer treatment MabThera (rituximab), which Cristiá said was approved in 2015 after a six-month review.

In terms of other review timelines in Cuba, Cristiá said it can take up to one year to approve new pharmaceuticals and biologics, six months for products already marketed elsewhere and as little as three months for generic drugs. Biosimilars have yet to be introduced to Cuba, he added.


In terms of the way pharmaceuticals and biologics are regulated in Cuba, Cristiá said the country’s framework relies mainly on World Health Organization (WHO) guidelines, though European Medicines Agency (EMA) and US Food and Drug Administration (FDA) guidelines have been considered.

The small US neighbor is also “slowly transitioning” to adopt guidelines from the International Council on Harmonisation (ICH), Cristiá said, noting specific conversations around the adoption of guidelines on good clinical practices (GCPs), good manufacturing practices (GMPs), as well as new methodologies for pharmacovigilance, preclinical and clinical studies.

As far as running clinical trials in Cuba, Cristiá clarified that it is not compulsory for bringing new products to market, and the island has one national contract research organization (CRO), known as the National Clinical Trials Coordinator Center (CENCEC). He also explained that over the past six months there has been a push from US pharmaceutical companies to run clinical trials for innovative products in Cuba.

Since 2000, the WHO has certified Cuba as the national reference authority (NRA) for vaccines, which Cristia said the country has been at the forefront of development since the 1980s. In addition, in 2010, Cuba was certified as an NRA by the Pan American Health Organization (PAHO).

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