US becomes fourth country to get EU API waiver
This article was originally published in SRA
The US has become the fourth country to be included on the European Commission's list of third countries that will be exempt from the burden of having to issue written confirmations to local manufacturers of active pharmaceutical ingredients (APIs) who wish to export their products to the EU1-3.
The exemption concerns a requirement of the EU Falsified Medicines Directive (FMD) that comes into force on 2 July, and it means that US companies will not need to obtain an export certificate from the Food and Drug Administration before shipping APIs to Europe.
The commission added the US to its list of countries exempt from the written confirmation requirement after determining that the FDA’s good manufacturing practices are at least equivalent to those in Europe. The FDA filed a formal “listing request” with the commission in January; the commission audited the FDA's regulatory and inspectional oversight of APIs on13-20 May. The other three countries "listed" by the commission are Switzerland, Australia and Japan.
Without the waiver, all US companies shipping APIs to Europe after 1 July would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe's good manufacturing practices, the FDA said.
The FMD requirement for the import of APIs is designed to respond to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world.
References
1. Official Journal of the European Union, Commission Implementing Decision of 11 June 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, 21 June 2013, L169. 71-72, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:169:0071:0072:EN:PDF
2. FDA press release, 21 June 2013, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358122.htm
3. Scrip Regulatory Affairs passim