USP’s Generics Access Plan to Encourage Competition

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The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

On Jan. 31, 2019, the US Pharmacopeial Convention (USP) announced its Generics Access Plan to facilitate competition in the drug market through new and revised quality standards and collaborations with regulators and industry groups. USP issued the plan as part of its support for FDA’s efforts to increase patient access to medications.

The new plan will include the development and updating of quality standards, training and education for generic-drug manufacturers on best practices for applying quality standards, and working with industry groups and regulators to identify ways to support generic-drug development.

“Millions of Americans have benefitted from generic medicines and in just the last 10 years $1.5 trillion have been saved, yet there are still many off-patent medications that have few or no generic alternatives,” said Ronald T. Piervincenzi, PhD, USP chief executive officer, in a press release. “While there has been much progress, there are still many off-patent drugs that have limited or no generic options. We must close this gap, which is why USP is committed to doing our part by developing new public standards and processes, working with the FDA and others to facilitate greater access to important drug therapies.”


USP quality standards, requirements, testing methods, and quality expectations are available for generic-drug manufacturers worldwide to ensure the quality of drugs. “Manufacturers can rely on USP quality standards, helping accelerate availability of generic versions of off-patent medicines,” said Piervincenzi. “This helps provide patients more access to affordable alternatives of the medicines they need.”

Source: USP