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  • Regulatory NewsRegulatory News

    US Clears Way for Cuban Drugs

    Under the auspices of a new presidential policy directive aimed at promoting greater engagement between the US and Cuba, the US Departments of Treasury and Commerce on Friday announced changes that will clear the way for Cuban-developed drugs to gain approval by the US Food and Drug Administration (FDA). The changes, which take effect on Monday, are being made through two amendments to the Cuban Assets Control Regulations to enable greater levels of interaction be...
  • Regulatory NewsRegulatory News

    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 no...
  • RAPS' LatestRAPS' Latest

    Head of Cuban Regulatory Agency to Make First Appearance at Regulatory Convergence

    This year, for the first time ever at RAPS’ Regulatory Convergence , attendees will have the opportunity to hear directly from Cuba’s top regulatory authority. Rafael Perez Cristia, director, Center for State Control of Drugs, Medical Devices (CECMED), Ministry of Public Health, Cuba, will participate in two sessions— Latin America: Perspectives and Challenges Moving Forward, Part 2 and Latin American Regulations and Market Access: Orphan Drugs, Rare Diseases and ...
  • Cuba-Brazil Bilateral Agreement Fosters Drug and Vaccine Development

    According to the director of Brazil's national regulatory agency (Anvisa), Dirceu Barbano, the cooperative exchanges of regulatory information and technology facilitated by a bilateral agreement between Cuba and Brazil have been "beneficial" in the development of new drugs and vaccines. The two countries have established a cooperative framework through which they have produces millions of meningococcal vaccines intended for use in Africa. According to reports, the agreem...