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Harmonization on Biologicals projects

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International Adoption of Non-Animal Alternative Methods in Batch Testing of Biological Products Projects

Project aim

In the production of biological products, manufacturers are required to confirm potency and safety of each batch of product. This may involve the use of laboratory animals. Directive 2010/63/EU prohibits manufacturers in the EU from using an animal test method if an alternative, non-animal method is recognized by the European Pharmacopoeia. However, if alternatives are not internationally harmonized and accepted in other regions then excessive or unnecessary animal testing is required by manufacturers in order to gain access to other, non-EU markets. The Biologicals project run under EPAA aims to achieve global harmonization in batch testing requirements for human and veterinary vaccines as well as other biologicals, leading to better incorporation of the 3Rs into potency and safety testing strategies.

Project deliverables include mapping of regulatory bodies responsible for establishing potency and safety testing requirements, identifying key differences in QC testing requirements between pharmacopoeias or equivalents and assessing test methods with related benefits and risks. The final results, case studies and recommendations will be presented and discussed with invited regulatory authority representatives at a dedicated workshop to be held later in 2014 with a view to progressing to full international harmonisation. 

Stakeholders involved

European Medicines Agency, European Commission, Pharmaceutical Industry, Animal Health Industry, 

Milestones

  • 2013: Project launch
  • 2013: Mapping of regulatory bodies responsible for potency and safety testing requirements

Upcoming events

  • 2014: Q4 (TBC) Workshop on international harmonization of biologicals