The Food and Drug Administration (FDA) will be collaborating with its European counterparts in regulating generic drugs, the agency announced Wednesday. The European Medicines Agency (EMA), which is a decentralized agency of the European Union (EU), along with France, Germany, Italy, the Netherlands, and the UK, will be involved in the collaboration, which will review the testing stage preceding generic drug applications.
“This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies,” the FDA stated in a news release today.
The pilot phase of the program will begin on Jan. 2, 2014, and will involve inspecting facilities that are used in clinical trials for generic drugs. Generic drugs are essentially copies of other brand-name medications and are typically the same as those in terms of dosage, safety, quality, and strength. In order for generic drugs to be approved and considered equal to branded medication, the agencies must conduct bioequivalence tests, which analyze how the drugs work in the human body. “Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug,” the FDA wrote on its website. “All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs.”
The FDA has already been collaborating with the EMA as well as the EU since September 2003, according to the EMA. The arrangement allowed “the exchange of confidential information between the EU and the FDA as part of their regulatory and scientific processes,” the EMA writes on its website. Together, the agencies developed common procedures for manufacturing, clinical and inspection processes. Now, they will be able to share information on inspections of bioequivalence studies, negative inspection outcomes, as well as conduct joint inspections all over the world.
“Our continued collaboration with the EMA and the EU enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the news release. “By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs.”