The Food and Drug Administration announced a two-year pilot program aimed at improving drug safety. Known as the Secure Supply Chain program, the voluntary effort seeks to enlist 100 drugmakers that would help demonstrate the feasibility of a system for guaranteeing the safety of foreign-produced drugs and active ingredients, according to a news release.
The program would require participants to document and maintain strict control over the production of their drugs from manufacturing points to entry into the country. If effective, the supply-chain safety program would allow FDA inspectors to expedite entry of products that meet the programs criteria and focus attention on those that might not be compliant, agency officials said.
With the increase of drug products produced outside of the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that dont meet the FDAs standards and violate U.S. laws, said Michael Chappell, acting associate commissioner for FDA regulatory affairs, in a news release.
To participate, drugmakers must hold an FDA-approved drug application or be a foreign manufacturer identified in an FDA-approved application; only use active pharmaceutical ingredients that are approved for use in FDA-cleared drugs; be FDA-registered and comply with agency's Good Manufacturing Practices; and document that their drug products use a secure supply chain.