FDA to improve safety of drugs and APIs produced outside US
The US Food and Drug Administration is to launch a voluntary two-year pilot programme to help promote the safety of drugs and active pharmaceutical ingredients produced outside the US.
The US Food and Drug Administration is to launch a voluntary two-year pilot programme to help promote the safety of drugs and active pharmaceutical ingredients produced outside the US.
The agency plans to select 100 applicants to participate in the Secure Supply Chain pilot programme. To qualify, applicants will need to meet a number of criteria, including a requirement that they maintain control over the drug products from the time of manufacture through to entry into the country. Each applicant may designate up to five drugs for selection in the pilot programme.
The aim of the pilot scheme is to allow the FDA to determine the practicality of developing a secure supply chain programme that would assist its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements. It would allow the agency to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant, while at the same time expediting the entry of products meeting the pilot's criteria into the US.
"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, director of the office of compliance in FDA's Center for Drug Evaluation and Research (CDER). "
"With the increase of drug products produced outside the US, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate US laws," said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. "Consumers should know that only companies that maintain control over their products will be selected into this pilot programme."