Is simultaneous submission and regulatory approval a reality towards faster patient access to medicines in the ICH region and beyond? [Abstract]

Salek, Mir-saeed, Kamau, P., McAuslane, N, Pichler, F. and Walker, Stuart 2010. Is simultaneous submission and regulatory approval a reality towards faster patient access to medicines in the ICH region and beyond? [Abstract]. Pharmacy World and Science 32 (2) , pp. 218-219. 10.1007/s11096-010-9378-9

Full text not available from this repository.

Abstract

The pharmaceutical industry has a global market size in excess of $600 billion. The industry has in recent times been the centre of much focus as its productivity levels have declined whilst the research and development cost have continued to rise. As the figures for drug development continue to escalate, sustainability of the current development model is being questioned and pharmaceutical companies are re-evaluating their development strategy with focus on implementing a global development programme to enable them to submit simultaneously in a number of regulatory authorities. Regulatory authorities’ role is to safeguard public health and ensure that the drug approval process is carried out in a timely manner. However, pharmaceutical companies can also influence this through the dossier submission strategies used. The aim of this study was to review approvals of new active substances (NASs) by US FDA, EU EMEA, Australian TGA, Canadian TPD, Japanese PMDA and Swissmedic between 1997 and 2008, in order to determine whether the harmonisation of technical guidelines (ICH) has enabled simultaneous submissions and approvals in these markets.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Pharmacy
Subjects:	R Medicine > RM Therapeutics. Pharmacology R Medicine > RS Pharmacy and materia medica
Additional Information:	ESCP–GSASA 38th symposium on clinical pharmacy 30 years of clinical pharmacy; a bright future ahead, 3rd–6th November 2009, Geneva, Switzerland
Publisher:	Springer Verlag
ISSN:	0928-1231
Last Modified:	07 Feb 2022 11:01
URI:	https://orca.cardiff.ac.uk/id/eprint/32852

Actions (repository staff only)

Edit Item