ANNEX 1 Revision Task Force Update

PDA continues to support efforts to improve the manufacture of sterile pharmaceuticals and the corresponding guidelines and regulations that are applied well beyond the European Union by both the industry and inspectorates. To that end, PDA has been actively engaged over the past five years in updating its aseptic processing documents and providing consensus-based comments to the EU EMA for the revision of Annex 1.

The globally diverse PDA Annex 1 Revision Task Force diligently developed recommendations taking into consideration input received during PDA workshops, conferences, and meetings held globally throughout the 2017-2020 Annex 1 revision and review process. In July of 2020, PDA submitted 88 general and specific comments and recommendations prepared by the Task Force to the EMA as part of the Annex 1 targeted second consultation.

In addition, the PDA worked on an Inter-Association effort across multiple global organizations to ensure that the common industry needs and thoughts on the revision are communicated to the EMA. As part of that effort, an Inter-Association letter presenting common views was sent to the EMA prior to the submission of specific comments.

It has been reported that the second Annex 1 consultation has resulted in approximately 2,000 comments collected by the European Commission, PIC/s and WHO. The Annex 1 Inspector Working Group is currently reviewing an addressing those comments. The EMA has not released an official timeline for the final publication of the revised Annex. It is speculated that once the revision is published, EMA will then communicate the planned implementation timelines.

The efforts made by the PDA and its Task Force are of importance considering the Annex 1 revision and the guidance it presents will have a great impact on the global pharmaceutical and biopharmaceutical industry and product supply for years to come. The EMA set a key objective in its 2015 Annex 1 revision concept paper to embrace the use of new technologies and to encourage the introduction of new technologies that are not currently addressed. The inclusion in the Annex 1 Working Group of experts from national and international (EMA, PIC/S, WHO) agencies across the world is a welcomed directional move towards a global harmonization of requirements.

PDA continues to be committed to assisting in the development of this importance guidance. Upon completion of the revision, PDA will remain committed to assist the EMA (PIC/S and WHO) with any educational, training, or communication efforts required to ensure a harmonized interpretation and implementation of the principles, recommendations, and requirements presented in the Annex.