Regulatory Focus™ > News Articles > Report, Guideline on Target Animal Batch Safety Test for Vaccines Released by EMA

Report, Guideline on Target Animal Batch Safety Test for Vaccines Released by EMA

Posted 23 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a report and a guideline on 23 January about target animal batch safety tests (TABST) for veterinary vaccines. EMA has been trying to implement a waiver system for TABST requirements for marketing authorization holders (MAHs), but has received significant pushback from companies claiming that the waivers aren't worth their time. The report highlights their concerns, while the guideline revises the data requirements necessary to obtain a TABST waiver in light of those concerns.

TABST are used to determine the consistency of products intended for use in animals. This is particularly important in biological products such as vaccines where products have inherent batch variability, and small manufacturing or process changes can affect the final product's safety and efficacy profile. TABST testing is meant to ensure adherence to appropriate specifications.

In 2004, EMA sought to ease batch testing requirements for MAHs by allowing the waiver of requirements when "a sufficient number of consecutive batches have been produced and found to comply with the test, thus demonstrating consistency of the manufacturing process." This consecutive batch number was later defined as 10.

EMA's report, EMA report on the implementation of the possibility for waiving the target animal batch safety test for immunological veterinary medicinal products in the European Union, identifies a number of concerns from industry about the TABST waiver requirements.

Industry comments to EMA include:

  • Regulatory requirements between EMA and the European Pharmacopoeia (Ph. Eur.) are disharmonized, and the testing needed to obtain a waiver does not apply to Ph. Eur. requirements
  • The value-add of re-assessing safety tests is questionable given that the existing batches comply with requirements
  • The added value of re-assessing pharamcovigilance data is resource-intensive and of questionable value
  • The necessity of an expert report is of questionable value
  • The regulatory report required placed a heavy resource burden while conflicting with the goals of the waiver

In light of these concerns, EMA is advancing efforts to harmonize regulatory requirements through the Veterinary International Conference on Harmonization (VICH), and EMA noted that a draft VICH guideline on the topic has been released for public consultation.

EMA also released a guideline today on data requirements for removing the TABST for immunological veterinary medicinal products in the EU.

That guideline, Guideline on data requirement for removing the target animal batch safety test for immunological veterinary medicinal products in the EU, "outlines the data requirement to be submitted by the MAH in order to waive TABST for the marketing of a product.

The guideline harmonizes the data requirements for removing the target species safety test between the Ph. Eur and EMA, and provides a number of points to consider for removing the TABST for target animal safety.

These requirements include data about the characteristics of the product and its manufacture, information available on the current batch safety test, pharmacovigilance data and other assorted data. EMA notes that this is not considered an exhaustive list.

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