EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

Regulatory NewsRegulatory News
| 21 August 2019 | By Zachary Brennan 

The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs).

The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product has been manufactured and tested in a country with a relevant mutual recognition agreement (or equivalent arrangements) with the EU.

“The exemption from re-testing batches upon import into the EU for ATMPs may only be granted where the conditions laid down in paragraph 11.17 of the EU GMP guideline for ATMPs are met,” EMA says, noting specifically:
  1. “limited amount of material available;
  1. short shelf-life;
  1. the testing in the third country should be conducted in GMP-certified facilities.”
EMA says that companies planning to use this exemption should consult with the agency early on and that this “exceptional exemption is primarily foreseen for imported patient-specific ATMPs (e.g. autologous product).” And technical difficulties in the transfer of analytical methods from third countries to the EU “cannot be used as a basis to accept an exemption from re-testing of batches imported into the EU,” the Q&A says.

To justify the exemption from batch re-testing in the EU for imported ATMPs, EMA calls on companies to provide at least the following in the initial marketing authorisation application: “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 an EEA Competent Authority relevant to the particular category of testing at the facility located in the third country.”

In addition to this Q&A, EMA in June released a Q&A on using out-of-specification (OOS) batches of ATMPs. Novartis previously provided OOS doses of its cell therapy Kymriah (tisagenlecleucel) under a compassionate use program in the US.

Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

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