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.
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...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
