The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > EU, US Regulators Team up to take on Generic Pharmaceutical Manufacturers

EU, US Regulators Team up to take on Generic Pharmaceutical Manufacturers

Posted 18 December 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding.

But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, making it difficult for regulatory officials to conduct facility inspections or examine bioequivalence study data-the data used to show that a drug is generic to another drug.

The shortfalls of these limitations are perhaps best seen in the case of Ranbaxy, which pleaded guilty earlier this year to falsifying bioequivalence data in support of several generic drug products, calling into question FDA's ability to safeguard consumers against fraudulent or manipulated data.

But even as new user fee funding under the Generic Drug User Fee Act (GDUFA) promises to give FDA the resources it needs to better inspect these facilities, the agency is moving to strengthen its generic drug regulatory system in another way as well.

FDA has announced that it is teaming up with its EU counterpart, the European Medicines Agency (EMA), with the stated purpose of sharing information on facility inspections and bioequivalence studies.

The change, FDA explained in a statement on 18 December 2013, will allow both regulators to streamline how they share information, quickly highlight information about deficient manufacturing facilities or analytical data, conduct joint inspections and better train inspectors.

The project, called the Generic Drug Application Inspections Initiative, will begin with an 18-month pilot phase, after which time it may be expanded.

"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," said Janet Woodcock, director of CDER, in a statement. "By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs."

Information obtained in the exchange program will be kept confidential per existing FDA-EMA agreements, FDA added.

FDA Statement


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.