Q. Assuming FDA will not take any action, what does this mean for APIs originating in the US for import into the EU after
July 1, 2013?
A. These APIs will be illegal and cannot be placed on the market. Given the extremely short timeline, this has already caused
some NCAs, such as the United Kingdom's MHRA, to publicly voice concerns over drug-supply shortages as a result of this legislation.
Of course, the EU agencies could go and inspect API manufacturers in non-EU countries, something that is happening already.
The problem is the sheer number of these manufacturing sites and the limited resources for inspection. It simply isn't an
option for most sites.
Q. Are there options for transitional solutions?
A. The EC has remained adamant that the law (i.e., the directive) cannot be changed and must be enforced. Nonetheless, there
are many diplomatic missions underway to assure a continued drug supply in Europe. But, some companies have already taken
steps to move their drug product manufacture out of Europe.
And do not forget that this directive affects not just the manufacturers, but all involved in the import and handling of the
APIs, such as importers, wholesalers, and brokers. They must comply with good distribution practices (GDP) and may be inspected.
It is not helpful that the new EU GDP guidelines are only expected for publication in early 2013. This leaves very little
time for industry to become compliant.
Q. What do you think industry should do?
A. Industry associations are already working very hard and in collaboration with the EU authorities to gain as much clarity
on what needs to be done and how. Engaging with industry associations or non-profit organizations such as the International
Society for Pharmaceutical Engineers (ISPE) and the Parenteral Drug Association (PDA), next to carefully watching information
coming from the agencies are the best sources of information. Unfortunately, there is very little that industry can do, but
a lot that must be done by a number of agencies. At the moment, the verdict as to whether this directive proves to benefit
the patients or brings about drug shortages is wide open.
More information on the organizations mentioned in this article can be found at their respective websites:
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