Annex 1 – The Brave New World Of Regulatory Compliance

By Kevin Owen

After six years in draft form, the revision to Annex 1 was finally released in August 2022, and will become effective in August 2023.

Those following the journey of the draft Annex 1 through to fruition have already identified and largely anticipated the changes to the previous Annex 1. Indeed for many pharmaceutical manufacturers, Annex 1 now aligns closer with the technologies and processes they have already built into their manufacturing facilities over the last few years.

For others whom waiting for the Annex 1 to become live has been the modus operandi: now is the time to act. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.