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Cuba's CECMED Director Reflects On Agency Transformations, Ongoing Challenges

 
• By Michael Cipriano

CECMED Director Rafael Pérez Cristiá discusses the drug regulator's increase international collaboration, connecting with industry and the relationship with US companies in an exclusive interview with the Pink Sheet.

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Cuba's State Center for Control of Drugs and Medical Devices (CECMED gained recognition from the Pan American Health Organization (PAHO) in 2012 as a National Regulatory Authority of Regional Reference, and the increased international collaboration and convergence has been a boon to the agency's regulatory processes, CECMED Director Rafael Pérez Cristiá says.

But the island nation's drug regulator also faces a number of challenges, such as the agency reviewers keeping up with...

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• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

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• By Dave Wallace

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UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 
• By Neena Brizmohun

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

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More from Compliance

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”