The European Union appears to be moving ahead with rules that next year active pharmaceutical ingredients (APIs) exported to EU countries must be certified by some authority in the country from which the originate.
The EU recently sent letters to trade groups in the EU, asking how their members intended to meet the new rules, according to postings on several EU law firm websites. PharmaTimes reports that beginning Jan. 2, all imported APIs must meet EU GMP standards and that beginning July 2, companies better have the documentation to prove it.
The regulations are intended to keep counterfeit or substandard APIs from getting into the EU but there has been some concern raised about the new regulations disrupting supplies to drugmakers. Some EU members, like Great Britain, are worried that if companies and countries don't get their acts together, supplies will not be certified and shortages will result. They are particularly concerned about India and China, which now account for an estimated 80% of bulk APIs.
Indian authorities recently said they will be prepared to meet the rules by determining what agency will issue the certifications. Supplies from China have been of particular concern after 80 deaths and hundreds of illnesses in the U.S. in 2008 were tracked back to tainted heparin from China. Chinese authorities have tried to crack down but problems there with substandard API makers are an open secret. Whether the government is prepared to help companies there comply is uncertain.
According to the new rules, written confirmation will be required for each API batch manufactured and documents to that effect will have to accompany them to their destination. The EU directive, passed in 2011, gives a pass to countries to which it has granted exemptions because it has determined that their standards are up to the EU's. PharmaTimes says Switzerland, Israel, Australia, Singapore and Brazil are all seeking that sign of approval and that the EU is in the processing of determining if which might be granted it.
- here's the PharmaTimes story
- here's a reference to the EU letter