2020 Annex 1 draft: Holistic changes

摘要

The EU GMP Annex 1 sets out the guiding principles for the manufacture, control and release of medicinal products that are produced within Europe and the standards required for products imported into Europe (this includes a post-Brexit UK, as EU GMP continues to apply). Annex 1 has not undergone any major revision since 2007 (there was a minor update in 2009); however, a new version is expected to be issued in 2020.