U.S. API makers couldn't imagine that the European Commission would not give them a pass on the new rule for proving that their manufacturing is equal to standards in Europe. But it took almost up to the last minute for regulators to acknowledge it.
An audit by the European Commission needed to reach its decision didn't occur until the week of May 13th, less than two months before the July 2 rule is to go into effect. "Working with the EC, the FDA has helped U.S. pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines," FDA Commissioner Margaret Hamburg said in announcing the designation. "At the same time, the FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe."
The U.S. is now one of only four countries to be allowed to export products to Europe without each shipment having to be accompanied by a certification from regulators that the plant it came from has been inspected and meets cGMP standards. The U.S. joins Switzerland, Japan and Australia in being exempted.
Drugmakers in the European Union have been warning regulators there for months that they could face shortages of essential APIs when the rule kicked in. Drugmakers in the U.K. were perhaps the most insistent, and so that country has created ways around the provision. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. says that if a drugmaker can show their supplies will be interrupted, it can apply to have its APIs allowed into the country without the required documents. The EU passed the law in 2011 to protect against counterfeit and inferior drugs and ingredients reaching Europe.
Drugmakers have been most concerned that China and India, which account for the largest number of API makers, would not get certifications issued in time to meet the deadline. Some progress has been made. India has just released a list of 57 plants that it has certified, including many of the largest API makers. Some of the biggest drugmakers, like Teva Pharmaceutical Industries ($TEVA), Mylan ($MYL) and Ranbaxy Laboratories, have plants on the list. China earlier indicated that it would inspect manufacturers that produced for the domestic market, but not those that only sold outside of China.
- here's the FDA announcement