Updates on Mutual Reliance Between the US FDA and the EU on GMP Inspections

This article is courtesy of Anthia Zammit Legal, a member of the EACCNY.

At present date, there is no Mutual Recognition Agreement (MRA) in relation to:

•  conformity assessment of regulated products, and
•  Good Manufacturing Practice (GMP)

for human and veterinary medicinal products in operation between the EU and the US.

On November 14th and 17th 2014, representatives of the US FDA met with a cross-agency team from the European Medicines Agency (EMA), the European Commission, and Good Manufacturing Practice (GMP) experts from EU member states in order to make progress on mutual reliance between the FDA and EU on GMP inspections. Initiatives have been ongoing in this field for several years but there is now renewed momentum on this issue.

Representatives of both teams have met several times in recent months, answered questions and exchanged information. This meeting was the first face-to-face meeting of both complete teams specifically organised on this topic. It is intended to clarify and align aspirations and goals, detailed scope and timelines as well as to continue the exchange of information, clarification and discussion on respective systems for supervision of manufacturers.

Simplified US FDA procedure for experimental drugs:

According to the New York Times’s article “Quicker Access to Experimental Drugs,” “Patients would be eligible only when there is no other product that can diagnose, monitor, or treat the patient’s disease or condition, and the patient cannot be enrolled in a clinical study testing it. The doctor must determine that the probable risk from the experimental drug is not greater than the probable risk from the disease. The doctor must also ensure that the manufacturer is willing to provide it.” For additional information about the US FDA’s new simplified procedure introduced to get quicker access to experimental drugs in the US, read the rest of the article here.

References:

1. European Medicines Agency, http://www.ema.europa.eu/ema/.
2. The New York Times, http://www.nytimes.com.