Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries.
Ther Innov Regul Sci
; 57(3): 484-514, 2023 05.
Article
en En
| MEDLINE
| ID: mdl-36463352
ABSTRACT
Regulators and pharmaceutical companies across the world are intensifying efforts to get increasingly complex and innovative drugs to patients with high unmet medical need in the shortest possible time frame. This article reviews pathways to expedite drug development and approval available in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Australia. It is concluded that the increasing availability of expedited regulatory pathways and associated modernisation of regulatory systems changes the current regulatory paradigm and requires sponsors to rethink drug development and regulatory strategy. A transformation of the current sequence of regulatory submissions, favouring those countries/collaborations that are best regulatory equipped to make innovative medical need drugs available to patients in the shortest time frame is imminent.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Aprobación de Drogas
/
Desarrollo de Medicamentos
Límite:
Humans
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2023
Tipo del documento:
Article
País de afiliación:
Reino Unido