ATMP from Third Countries - New Q&A Paper on Batch Release published

Recommendation

14/15 December 2023

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In a three-page document from July, the European Medicines Agency (EMA) commented on the possibilities for ATMP imports from a third country into the EU to refrain from a new batch test. The present Questions and Answers catalogue first clarifies the fact that the responsible QP is also responsible for ensuring that each batch has been manufactured in accordance with Good Manufacturing Practice and that the quality meets the conditions of the approval. In accordance with Directive 2001/83/EC, new tests of imported batches are usually required for this purpose. Such testing can only be waived if the product has been manufactured and tested in a country that has a corresponding mutual recognition agreement or an equivalent agreement (MRA) with the EU and therefore the batch testing can be acknowledged there.

Conditions for waiver of testing

In addition, this document discusses the conditions under which such testing may be waived:

• For a limited quantity of available material;
• Or with a short shelf life;
• And if the tests in the third country are carried out in a GMP-certified facility.

Laboratory or similar difficulties in method transfer of analytics are not considered plausible. Since such an exemption from CAT/CHMP must be examined during the evaluation of the authorisation procedure, such an application should be considered at an early stage in the product development process.

The document then discusses the data that an applicant should submit to the EMA in order to obtain an exemption. This includes

• Total batch size and number of units required for batch release testing;
• Available stability data and proposed shelf life;
• Analytical sampling plan;
• A GMP certificate issued by a competent authority of the EEA and relevant to the specific category of tests in the establishment located in the third country.

Finally, the EMA paper then refers once again to the existing obligations of the Qualified Person with regard to batch release without further examination.

More detailed information can be found in the EMA document "Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country".