EU is introducing new rules for importing APIs for human-use medicines into Europe. From 2 January 2013, all imported APIs will be required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP.

As of 2 July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country – the importer will need to request this confirmation from the authority in question. This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of GMP at least equivalent to that in the EU.

FDA is also tightening the importation of APIs into the US. Under an Import Alert issued on 14 August 2012, field officers are being advised to employ the Establishment Evaluation System to determine whether an imported API and its manufacturer have valid authorization.

Will this work?
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 do not get their acts together, supplies will not be certified and shortages will result. They are particularly concerned about China and India, 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 US 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 to comply is uncertain.

A way of coping with the new requirements and the possible shortages that may arise has been written into the regulations. Exceptionally, and where necessary to ensure the availability of a particular product, a Member State may decide to waive the need for a written confirmation, for a period not exceeding the validity of the GMP certificate.

Super league of trusted API producers
A few countries will be granted exemptions if the authorities decide that their standards are up to the EU’s. Australia, Brazil, Israel, Singapore and Switzerland are all reportedly seeking that sign of approval and the EU is apparently in the process of determining to which country, if any, the approval might be granted.

The new rules will not apply to APIs to be used in investigational medicines or products to be used in R & D trials. Nor will they apply to active substances contained within imported finished medicines – for these, the current rules will continue to apply.

Related articles

Twenty per cent of generic drug user fees to come from API manufacturers

FDA blocks Indian API supplier

Permission granted to reproduce for personal and educational use only. All other reproduction, copy, retransmission or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.