FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration announced that the U.S. is now a "listed" countrydisclaimer icon with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices.

To avoid that burden for companies, the FDA filed a formal "listing request" with the EC in January 2013 that the FDA's good manufacturing practices be considered at least equivalent to those in Europe.

The EC has now approved that request following a comprehensive audit of the FDA's regulatory and inspectional oversight of APIs. The audit took place from May 13 - 20, 2013.

"Working with the EC, the FDA has helped U.S. pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines," said FDA Commissioner Margaret A. Hamburg, M.D. "At the same time, the FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe."

Europe's requirement for the import of APIs falls under its Falsified Medicines Directive, enacted in 2011 in response to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world.

Protecting consumers around the globe from falsified medicines is an enormous and complex undertaking that requires international cooperation. Over the past several years, the FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade, and product safety and quality, have no borders.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Positive Phase 1 data from mRNA-based individualiz…

BioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability o...

FDA approves RIABNI™ (rituximab-arrx), a biosimila…

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with ...

Pfizer to invest $120 million to produce COVID-19 …

Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Mic...

Proteomic study of 2,002 tumors identifies 11 pan-…

A new study that analyzed protein levels in 2,002 primary tumors from 14 tissue-based cancer types identified 11 distinct molecular subtypes, providing systematic knowled...

A new technology offers treatment for HIV infectio…

A new study from Tel Aviv University offers a new and unique treatment for AIDS which may be developed into a vaccine or a one time treatment for patients with HIV. The s...

Broadly neutralizing antibodies could provide immu…

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published Ju...

Sanoff offers perspective on a promising rectal ca…

UNC Lineberger Comprehensive Cancer Center's Hanna K. Sanoff, MD, MPH, is the author of a viewpoint in the New England Journal of Medicine that provides a perspective on ...

Boehringer Ingelheim signs option to acquire Truti…

Boehringer Ingelheim announced the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company. Trutino Biosciences...

Novel drug combo activates natural killer cell imm…

Most skin cancer drugs that activate the immune system work by triggering immune cells, called T cells, to attack tumors, but when T cells are activated for too long, the...

Novartis announces Nature Medicine publication of …

Novartis announced that Nature Medicine published final results from both the two- and three-copy cohorts of the completed Phase 3 SPR1NT trial as separate companion manu...

COVID-19 rebound after taking Paxlovid likely due …

Paxlovid is the leading oral medication for preventing severe cases of COVID-19 in high-risk individuals. However, symptoms returned in some patients after treatment was ...

Biomarkers found that could be drug targets agains…

Biomarkers that could be targets for novel drugs to treat glioblastoma brain tumors have been identified by investigators at Georgetown Lombardi Comprehensive Cancer Cent...