Non-EU regulators can use EMA/FDA data for API export letters

Non-EU regulators can use EMA/FDA data for API export letters

Related tags Active pharmaceutical ingredients European union Eu

Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.

The EC made the comments in the latest version of a Q&A​ document designed to clarify new European rules on the importation of active pharmaceutical ingredients (API) that come into effect next year.

Under the laws – part of the Falsified Medicines Directive – from January next year active pharmaceutical ingredients (APIs) exported to Europe must be produced in accordance with quality rules equivalent to those in place in Europe.

From July APIs shipped from outside the EU must be accompanies by written confirmation from a regulatory authority in the exporting country.

The ability of a non-EU country to issue written confirmation based on a previous successful inspection of an API producer by an EU regulator means that regulators in the exporting country will not have to revisit manufacturing sites just.

Inspectors in countries like India and China – which manufacture around 80 per cent of the APIs used in Europe – will be able to use data from organisations like the EU or the US Food and Drug Administration (FDA).


The new EU document also reiterated that the finished product manufacturer is responsible for checking that APIs have the required documentation, which is something that is unlikely to be welcomed by industry group Rx-360.

Last week​ the supply chain security organisation raised a number of concerns about the new regulations.

There are concerns that major markets may balk at these requirements. Active substances that are imported into the EU without written confirmation will likely be significantly delayed or rejected by EU member state customs.

It is the responsibility of Finished Drug Product manufacturers who is receiving the imported API to verify the written confirmation. Manufacturers should ensure their API suppliers are aware of the new guidelines to ensure the supply of medicinal products is not disrupted.​”

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