An array of efforts to protect the public from substandard or illegitimate medicine in the US and around the world demonstrate the importance of vigilance and the high level of coordination it can require.
The Quality Lowdown: The Effort Required To Stem Substandard, Illegitimate, Unapproved Drugs
As stakeholders in the US pharmaceutical distribution chain prepare to coordinate against suspect drugs, the world’s leading inspectorates collaborate on good distribution practices.

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Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such as a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.
Lilly is broadening the range of single-use vial dosage forms of its obesity drug and lowering prices of existing doses for self-paying customers, but maintains it can handle increased demand as compounding ends.
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Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.