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U.K. relents on July deadline for API certifications

Regulator will allow APIs in on case-by-case basis
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The U.K. has acknowledged what drugmakers have been warning of for months: There could be a shortage of ingredients if it doesn't give a little on the European Union's July 2 deadline for requiring imported APIs be certified as meeting EU standards.

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 that certify the manufacturer meets EU standards, in-Pharmatechnologist.com reports. The EU passed the law several years ago to protect against counterfeit and inferior drugs and ingredients reaching Europe, but drugmakers have warned for more than a year that many of their suppliers in places like India and China might not be able to meet the requirement in time.

An MHRA spokesman told the publication, "We discussed our contingency plans with the pharmaceutical industry and they are very supportive and have been lobbying other member states to adopt a similar approach."

Some documentation will still be required. The drugmaker must show it has done its own audit of the API maker within the last three years and found it meets EU GMP standards. The API maker must also provide documentation from a recognized regulator like the EU's MRA or the U.S. FDA that it has passed an inspection.

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, Regulatory Focus reports. 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.

- read the in-Pharmatechnologist.com story
- here's more from Regulatory Focus

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