EU API law has drugmakers there in panic
Drugmakers in Europe are panicking over the possibility that come July, they are not going to have the APIs they need to make their products. And so they keep pleading with the European commission to cut them some slack.
The new legislation is designed to prevent inferior APIs from getting into Europe by requiring that all shipments carry a guarantee that the maker has been inspected by its home country and that its products meet EU standards. But the largest producers of APIs in the world, China and India, have yet to get a process in place and inspections done. That has raised new levels of concern among drugmakers in the EU that they will not be able to get APIs, reports in-Pharma Technologist. The European Federation of Pharmaceutical Industry Associations (EFPIA) has suggested that European regulators raise their level of urgency in negotiations with China and India so there are no shortages.
Meanwhile, drugmakers are looking for alternate supplies, but in some case there are none, the EFPIA told the publication. "Although the deadline of July 2 is fast approaching, there is still a high level of unpredictability regarding the availability of the implementing measures," it said.
The rules allow for the EC to grant some countries exemptions based on the finding that their own oversight is equal to Europe and so API makers there do not need the certifications. But so far, only Switzerland, home to companies like Roche ($RHHBY) and Novartis ($NVS), has gotten the golden seal of approval and Israel has been turned down. The EFPIA said regulators at least could sign-off on the U.S. and Japan to ease the situation. The U.S. applied for the exemption in January and the fact that it has not heard back has some API makers in the U.S. concerned they will lose their European business as clients switch to new suppliers just in case.
"EFPIA recommends that third countries such as the USA or Japan that are known by the Commission to have adequate and mature systems should be subject to a simplified procedure for inclusion in the 'listing' and potentially be qualified for immediate "listing".
Other organizations, including the U.K.'s Medicines and Healthcare products Regulatory Agency have raised similar alarms, the publication points out.
- read the in-Pharma Technologist story