Spring Intro 2023

Jenny Lamport

Requirements for format and data content

Notice to applicants CHMP/ICH guidelines ● CHMP - Committee for Medicinal Products for Human Use ● ICH - The International Council on Harmonisation

– organisational changes following 25 years of harmonisation – global initiative, expanding beyond the previous ICH members – Health Canada, European Commission, Ministry of Health Labor and Welfare/Pharmaceuticals and Medical Devices Agency (Japan), Swissmedic, FDA …….20 members, 36 observers – more stable operating structure through the establishment as a legal entity under Swiss law – over-arching Assembly governing body instrumental in facilitating future growth through the participation of new members

The Organisation for Professionals in Regulatory Affairs

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EUDRALEX

Volume 1

Legislation

Volume 2

Notice to Applicants

A Procedures B Content of the dossier C Regulatory guidelines

Volume 3

Scientific guidelines (links back to EMA site)

Volume 4

GMP …………….

Volume 9

Pharmacovigilance

Volume 10

Clinical trials

https://ec.europa.eu/health/documents/eudralex_en

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