FDA Initiates the Secure Supply Chain Pilot Programme to Enhance Security of Imported Drugs
FDA is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this 2-year programme. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the US.
The goal of the programme is to enable FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the US drug supply.
“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The programme also allows FDA to focus resources on the areas with the greatest potential risk to consumers.”
During these next 2 years, FDA will evaluate the programme’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the programme to be effective, a more permanent programme may be established and possibly extended to additional participating companies.
The prequalified companies accepted into the programme that will receive expedited entry, are the following:
• AbbVie Inc.
• Allergan, Inc.
• Astellas US Technologies, Inc.
• Bristol-Myers Squibb Company
• Celgene Corporation
• GE Healthcare Inc.
• GlaxoSmithKline LLC
• Merck Sharp & Dohme Corporation
• Mylan Pharmaceuticals Inc.
• Novartis Pharmaceuticals Corporation
• Pfizer, Inc.
• Teva Pharmaceutcials USA, Inc.
• Watson Laboratories, Inc.
Each of the 13 companies met multiple participation conditions, including
• committing to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA)
• having a validated secure supply chain protocol per the US Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program
• having a plan in place to quickly correct potential problems FDA identifies regarding importation of specific products
• having effective recall and corrective action plans in place
• maintaining control over their drugs from the time of manufacture abroad through entry into the US.
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance