FDA and European Medicines Agency sharing work....:)

This article about sharing inspections work between FDA and European Medicines Agency. The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. This is a three-year pilot program to share work on facility inspections - including those making finished dosage forms - in each other's territories.

What is European Medicines Agency?

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union

What is FDA (Food and Drug Administration)?

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.

Why this collaboration developed ?

The latest initiative is designed to enable better use of the FDA and EMA's inspection resources, reduce the burden of inspections for medicines manufacturers, and allow the authorities' inspection capacity to be shifted to other, potentially more high-risk regions.

Regulatory agencies are trying to work more closely together on inspections in part to answer criticisms that they are failing to exercise adequate oversight of manufacturing facilities, in the face of a globalisation in the supply chain for pharmaceuticals and their ingredients.

For example, in 2009 the US General Accounting Office published a report indicating that the FDA was able to inspect only a small proportion (11%) of the 3,700-plus overseas facilities supplying APIs and finished drugs to the US market. 

"Pharmaceutical manufacturing has increasingly shifted away from Europe and the US," said the FDA.


When it is starting?
The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. 

What are advantages of this working together ?

• Enable better use of the two authorities' inspection resources;
• Reduce the burden of inspections for medicines manufacturers;
• Shift the authorities' inspection capacity to other regions.

Where to apply?

The initiative will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or United States of America. It will focus on sites that are already known to the two authorities and have a history of compliance with good manufacturing practice (GMP) following previous inspections.

When they will review the outcomes of this collaboration?

The outcomes of the initiative will be reviewed after three years.

With regards,

Santhosh Rao Mennani

Posted in: Industry updates,Regulations