update
US asks for exemption from EU API import laws
The US Food and Drug Administration (FDA) asked to be included on the list of ‘third countries’ deemed to have good manufacturing practices (GMP) rules equivalent to those in the European Union.
The agency said the request “sends a clear and strong message that recognition of equivalent scientifically-based standards better protects the public and provides a greater level of protection for more people,” adding that working with the EU in this way underlines its commitment to meet the challenges of globalization.
It also said that: “United States exporters of APIs benefit greatly from FDA’s Listing Request. If the FDA’s listing request is approved, exporters will avoid duplicative administrative efforts, which could impede trade and delay the manufacture of needed medicines.”
The FDA is not the first organization to raise concerns about the new import law’s impact on the availability of drugs. In December, the MHRA said the UK may have to ‘reserve its position’ on the new legislation “in order to ensure the availability on medicinal products.”
John DiLoreto executive director of SOCMA's Bulk Pharmaceuticals Task Force (BPTF) told in-Pharmatechnologist.com "we’re glad that FDA has decided to apply for an exception. It was the easiest way for all parties concerned to meet the needs of the Directive and it will go a long way in easing customer concerns regarding future supplies of APIs."
Exemption request
The US is the seventh country to ask the EU for a waiver behind Israel, Australia, Singapore, Brazil, Japan and Switzerland which was granted exemption last month.
At present, Israel – which submitted its request last summer – is the only country to have been unsuccessful. The European commission website states that Israel is not included on the list as “the relevant Israeli legislation covers only active substances used for the manufacture of finished products manufactured in Israel.”
To date, only Taiwan and Canada have said they are willing to provide manufacturers with ‘written confirmation’ that APIs are produced to European Union Standards, which will be required of all states not on the ‘third country‘ list from July 2.
In related news, last week China’s SFDA started a survey of the country’s API manufacturing sector citing the new EU import rules as a motivation.
Assessment criteria
The US request for exemption came just a few days before the framework used to assess potential third countries’ GMP regulations was published in the official journal of the European Union.
According to the one page document the Commission will base its equivalence assessment on a country’s guidelines on manufacturing, inspection resources, its alert and crisis management systems and ability to communicate information to the EU.
