FDA and EMA Seek Candidates for GMP Inspection Pilot - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA and EMA Seek Candidates for GMP Inspection Pilot


ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug-manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

A new EMA release states that companies that have submitted two separate but equivalent new drug application applications to EMA and FDA are eligible to participate in the pilot. Such companies will be inspected jointly by the regulatory agencies. In addition, if a company is expecting a routine surveillance or re-inspection by both agencies, that company can also participate in the pilot by hosting a single joint inspection.

“The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication,” says the EMA release.

Over the past couple of years, the agencies have conducted similar pilot programs. FDA, EMA and the Australian drug regulatory agency conducted an 18-month joint pilot inspection program focused on active pharmaceutical ingredient manufacture in countries outside of the three regions. This pilot officially began in November 2008. FDA and EMA ran a joint inspection pilot program of companies manufacturing drugs in both regions beginning in the spring of 2009 in order to better share information. The two agencies also ran an 18-month joint good clinical practices initiative starting in September 2009 to increase collaborative efforts to inspect clinical trial sites and studies.

The new GMP pilot program that is getting underway is meant to build on these experiences. Companies interested in the pilot should contact their respective agency at CDERInternationalGMP@fda.hhs.gov or gmp@ema.europa.eu.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here