Reliance into Action : Understanding EMA Documents to Streamline Reliance for Marketing Authorization Applications
Ther Innov Regul Sci
.
2025 Jun 28.
doi: 10.1007/s43441-025-00824-9.
Online ahead of print.
Authors
Isabelle Colmagne Poulard
1
,
Susanne Ausborn
2
,
Martin Harvey Allchurch
3
,
Victoria Palmi
3
,
Alberto Ganan
3
,
Angelika Joos
4
,
Andrew Deavin
5
,
Corentin Beauchesne
6
,
Priti Shah
7
,
Jyothsna Krishnan
8
,
Chaima Askri
9
Affiliations
1
Merck, 1 route de Crassier, Eysins, 1262, Switzerland. isabelle.colmagne-poulard@merckgroup.com.
2
Roche, Grenzacher Strasse 124, Basel, 4070, Switzerland.
3
European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam, 1083 HS, The Netherlands.
4
MSD, Boulevard du Souverain 25, Brussels, 1170, Belgium.
5
GSK, 20 Avenue Fleming, Wavre, 1300, Belgium.
6
Alexion, Av. Diagonal, 615, Les Corts, Barcelona, 08028, Spain.
7
Astra Zeneca, City House, Hills Rd, Cambridge, UK.
8
European Federation of Pharmaceutical Industries and Associations (EFPIA), Neo Building, Rue Montoyer 51, box 3, Bruxelles, 1000, Belgium.
9
Sartorius, Am Flughafen 16, 79108, Freiburg, Germany.
PMID:
40581695
DOI:
10.1007/s43441-025-00824-9
No abstract available
Keywords:
CPP/eCPP; EMA; Manufacturing authorization application; Regulatory convergence; Reliance.
Publication types
Review