Features | Partner Sites | Information | LinkXpress
Sign In
GLOBETECH MEDIA
GLOBETECH PUBLISHING LLC
GLOBETECH PUBLISHING LLC

US FDA and European Regulators Launch Generic Drug Inspections Initiative

By BiotechDaily International staff writers
Posted on 30 Dec 2013
The US Food and Drug Administration (FDA; Silver Spring, MD, USA) and the European Medicines Agency (EMA; London, United Kingdom) will work together to ensure consumers are buying suitable generic medications.

The joint initiative will share information on inspections of bioequivalence studies submitted in support of generic drug approvals, providing a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. Taking part in the collaborative initiative are the EMA and the European Union (EU) member states France, Germany, Italy, the Netherlands, and the United Kingdom. The initiative will be implemented using confidentiality arrangements already established among the European Commission, the EMA, interested EU member states, and the FDA.

Key objectives of the initiative are to streamline information sharing on inspections of bioequivalence studies conducted and planned for generic drug applications, with inspectional information shared for clinical facilities, analytical facilities, or both; sharing of information about negative inspection outcomes that reveal system problems at a facility; conducting joint inspections at facilities all over the world; and providing training opportunities to improve bioequivalence inspections.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research (CEDR). “By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs.”

Pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and they display comparable bioavailability when studied under similar experimental conditions. Bioequivalence is considered proven if the drugs are similar to such a degree that in terms of peak (Cmax and Tmax) and total exposure after administration of the same molar dose (under the same conditions), the effects can be expected to be essentially the same.

Related Links:

US Food and Drug Administration
European Medicines Agency



Channels

Genomics/Proteomics

view channel
Image: The photo shows a mouse pancreatic islet as seen by light microscopy. Beta cells can be recognized by the green insulin staining. Glucagon is labeled in red and the nuclei in blue (Photo courtesy of Wikimedia Commons).

Regenerative Potential Is a Trait of Mature Tissues, Not an Innate Feature of Newly Born Cells

Diabetes researchers have found that the ability of insulin-producing beta cells to replicate and respond to elevated glucose concentrations is absent in very young animals and does not appear until after weaning.... Read more

Drug Discovery

view channel
Image: Wafers like the one shown here are used to create “organ-on-a-chip” devices to model human tissue (Photo courtesy of Dr. Anurag Mathur, University of California, Berkeley).

Human Heart-on-a-Chip Cultures May Replace Animal Models for Drug Development and Safety Screening

Human heart cells growing in an easily monitored silicon chip culture system may one day replace animal-based model systems for drug development and safety screening. Drug discovery and development... Read more

Biochemistry

view channel
Image:  Model depiction of a novel cellular mechanism by which regulation of cryptochromes Cry1 and Cry2 enables coordination of a protective transcriptional response to DNA damage caused by genotoxic stress (Photo courtesy of the journal eLife, March 2015, Papp SJ, Huber AL, et al.).

Two Proteins Critical for Circadian Cycles Protect Cells from Mutations

Scientists have discovered that two proteins critical for maintaining healthy day-night cycles also have an unexpected role in DNA repair and protecting cells against genetic mutations that could lead... Read more

Business

view channel

Roche Acquires Signature Diagnostics to Advance Translational Research

Roche (Basel, Switzerland) will advance translational research for next generation sequencing (NGS) diagnostics by leveraging the unique expertise of Signature Diagnostics AG (Potsdam, Germany) in biobanks and development of novel NGS diagnostic assays. Signature Diagnostics is a privately held translational oncology... Read more
 
Copyright © 2000-2015 Globetech Media. All rights reserved.