LS&HC Horizons 2023 - Flipbook - Page 51
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Cross-jurisdictional
51
Significant change to EU GMP requirements for sterile
pharmaceutical manufacturing
By August 2023, pharmaceutical
manufacturers will need to meet certain new
regulatory expectations for aseptically prepared
products produced for the European markets,
leaving scant time to plan and implement
changes before regulatory authorities
begin to enforce the updated requirements.
The European Commission has revised
Annex 1 “Manufacture of Sterile Medicinal
Products” in EudraLex – Volume 4 – Good
Manufacturing Practice (GMP) guidelines.
These new regulatory expectations will affect
all sterile drug (medicinal) products intended
for EU markets and the UK, even if they are
manufactured in the U.S. or anywhere else
in the world.
The updates to Annex 1 include internationally
harmonized quality risk management
principles, but the revisions also significantly
expand regulatory expectations for
contamination controls related to sterility
assurance. Some of the changes will require
substantial capital investments and might lead
to supply disruptions. The updated Annex 1
also appears to be more stringent than current
U.S. requirements in certain respects, which
may impede longstanding efforts to improve
harmonization of regulatory requirements and
to enhance collaboration between U.S. and EU
regulators. Effectively, the EU GMP guidelines
are understood as the minimum standard that
manufacturers must meet, although regulatory
authorities can allow a differing approach
to meeting the goals of the standard if the
different approach is justified under a sound
scientific rationale that is fully demonstrated
with data.
David Horowitz
Partner, Washington, D.C.
Fabien Roy
Partner, Brussels
Mikael Salmela
Partner, Paris
Dr. Jörg Schickert
Partner, Munich
Jane Summerfield
Partner, London
For more details on
the new regulatory
requirements read
our analysis.
Giuseppe Aminzade
Counsel, Milan
Ted Lis
Counsel, Washington, D.C.
