[e-drug] Postmarketing Surveillance. New Regulations - CUBA

["Raul Yañez" <raulyv@infomed.sld.cu>]

E-DRUG: Postmarketing Surveillance. New Regulations - CUBA
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Dear colleagues,

Cuba will implement this year a series of new regulations. These regulations give the National Post-marketing Surveillance System the necessary legal foundation. They also include regulatory elements such as quality control of drugs in the market, fighting counterfeit drugs, and medicines promotion. They also include regulatory components of pharmacovigilance, such as periodic safety update reports, postmarketing surveillance studies, and pharmaco-economic studies, communication procedures and risk determinations.

The regulations can be found at:

	Postmarketing Surveillance Regulations:. www.cecmed.sld.cu/Docs/Pubs/AmbReg/2007/AmbReg-62.pdf

	Periodic Safety Update Reporting Requirements: www.cecmed.sld.cu/Docs/Pubs/AmbReg/2007/AmbReg-63.pdf

Expedited and Periodic reporting for Adverse Drug Reaccións, Intoxications, Quality Defects and Counterfeit Drugs Requirements:
	www.cecmed.sld.cu/Docs/Pubs/AmbReg/2008/AmbReg-65.pdf

Best Regards,

Raúl Yañez Vega. MSc
Postmarketing Surveillance Department
Inspection, Control and Surveillance Divition
State Control Center for the Quality of Drugs (CECMED)
Regulatory Authority of Drugs in Cuba