Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Pharmaceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries. Participants reported on country- and region-specific regulatory requirements and, where present, on the perspectives on the waiving and elimination of the Abnormal Toxicity Test. With AFSA, HSI, EFPIA and IABS representatives as facilitators, the participants also discussed specific country/global actions to further secure the deletion of ATT from all regulatory requirements worldwide.

Autogenous vaccines: Quality of production and movement in a common market.

An international meeting, held in Munich, Germany, on 14-16 September 2021, explored the expectations and views of different stakeholders regarding the implementation of the new veterinary medicines Regulation (Regulation (EU) 2019/6) in respect to inactivated autogenous vaccines (AVs) in non-notifiable diseases. Guidance documents on specific Good Manufacturing Practice (GMP) for AVs are scheduled to be developed at EU and a wider international level in the future. Presentations and discussions by the experts from regulatory authorities, industry and users made it apparent that their views on the quality requirements for the starting materials as well as quality standards for premises, personnel and manufacturing were broadly aligned for most of the aspects considered. The conclusions and recommendations of this meeting are expected to facilitate the development of urgently needed guidance documents for a harmonised implementation of this element of the Regulation.