EMA Maps Global Drug Supply Chain Regulatory Gaps For ICMRA
Gaps and overlaps in global and regional efforts to protect pharmaceutical supplies from intrusion of fake drugs, manufacturing quality problems and natural disasters are among the issues the European Medicines Agency has identified by mapping international initiatives for the International Coalition of Medicines Regulatory Authorities.
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International Coalition of Medicines Regulatory Authorities (ICMRA) wants regulators to think globally when designing and implementing track and trace systems so that counterfeit or substandard products identified in one jurisdiction can be tracked and halted at the borders of other countries. Existing systems have been designed with a national or regional focus only.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.