In an effort to decrease manufacturer’s admin, prevent possible drug shortages and encourage globalization, the US requested exemption from the new European Union (EU) import laws for active pharmaceutical ingredients (API)s. The exemption would place the US FDA on a list of ‘third countries’’ considered to have good manufacturing practice (GMP) rules equivalent to those in the EU, according to a recent article on in-pharmatechnologist.com. Other countries to request exemption include Australia, Singapore, Brazil, Japan and Switzerland. The Official Journal of the European Union recently published the assessment criteria, which includes examination of a country’s manufacturing guidelines, inspection resources, alert and crisis management systems and ability to communicate information to the EU. To read the full article on in-pharmatechnologist, click here. For further information on the assessment criteria, click here. Need assistance in managing your global supply chain including quality oversight of your API suppliers? Call us at 317.899.9341.
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