The following appeared in a recent issue of P&T Journal, and this is the type of model required to facilitate the cross border exchange of patients or international medical travel.
“FDA and EMA Launch Joint
Initiative for Generic Drugs
The FDA and the European Medicines
Agency (EMA) plan to work together on
a joint initiative to share information on
inspections of bioequivalence studies submitted
in support of generic drug approvals.
This collaborative effort provides a
way to conduct joint facility inspections
for generic drug applications submitted
to both agencies.
Studies submitted for generic drug applications
must prove that a generic drug
is “bioequivalent” (showing that a generic
drug performs in the same manner as
a brand-name drug). The FDA and the
regulatory authorities in the European
Union (EU) inspect facilities conducting
these studies to ensure that the data submitted
to the agencies are reliable.
Taking part in this initiative are the
EMA and the EU member states France,
Germany, Italy, the Netherlands, and the
United Kingdom. Streamlining the inspection
process for generic drug applications
should help consumers gain access
to safe and effective generic drugs.
Source: FDA, December 18, 2013”