China, India have yet to meet EU rule on APIs

Drugmakers in Europe have been sweating over whether China and India will meet a looming deadline to certify their APIs meet EU standards. An update from the European Commission is not likely to stop the fretting and the sweating. It says that both countries have made progress but do not have the process nailed down.  

The new legislation, which takes effect in July, 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. China and India combined have more than 930 API makers that need a sign-off, reports more than 60% of all the manufacturers tracked by the European Commission. India has said it will meet the deadline but the update puts that in question. China has told the EU it will not inspect any API makers that do not also produce for its own drugmakers, leaving the EU to figure that one out. That accounts for about 30, the publication reports. 

There are essentially two ways to meet the rules. They allow each country to have a regulator issue "written confirmation" that plants have been inspected and APIs meet the standards. The other approach is to get an EU exclusion based on the European Commission finding that the country's own regulatory inspections meet the EU standards. According to, in some exceptional cases an EU member state can decide to waive the rule.

The uncertainty of the situation has left European drugmakers to look for alternate supplies, but part of the problem is where to look. The U.S. and a host of other countries have asked for EC exception but so far only Switzerland has been approved. In a small concession to concerns, points out that the EC ruled that APIs "used for investigational medicinal products or for medicinal products intended for research and development trials are excluded from the rules."

- read the story
- here's the EMA update (PDF)