Matches in SemOpenAlex for { <https://semopenalex.org/work/W4382182775> ?p ?o ?g. }
Showing items 1 to 77 of
77
with 100 items per page.
- W4382182775 endingPage "394" @default.
- W4382182775 startingPage "385" @default.
- W4382182775 abstract "In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 2017 and provisional approval (PA) in 2018, which aim to facilitate expedited review and approval for novel medicines. The pathways were developed in consultation with a wide range of stakeholders and have since been utilised by pharmaceutical companies for various therapeutic products. However, the perceptions of the firsthand users of these pathways have not been evaluated in Australia.We have conducted a survey of Australian regulatory professionals aiming to solicit the perceived benefits, barriers to utilisation, shortcomings and proposed modifications to utilising these pathways. We have also solicited the users' perspective on key aspects of the pathways, including overall satisfaction, regulatory burden, availability and ease of use of guidelines, regulator support, impact on company strategy and recommendations for improvement.A survey was developed and distributed to Australian regulatory professionals from the pharmaceutical industry who had submission experience of new medicine applications via either PR, PA or the standard registration pathway to the Therapeutic Goods Administration (TGA). The questionnaire consisted of 44 questions with a skip logic and the option for free text comments.We received responses from 16/42 companies that had utilised these new pathways. Nine respondents had experience with the PR pathway and ten with the PA pathway. The respondents were generally satisfied with the effectiveness of the PR process in expediting registration approvals, but they were ambivalent towards the PA pathway in terms of overall satisfaction and timelines. Respondents expressed a desire for further improvements in the speed of approval, earlier access for patients across various pathways and introduction of new Health Technology Assessment processes for medicines approved under PA.While the FRPs have been an important and positive development in the Australian regulatory landscape, there remain opportunities for further improvements, some of which have been highlighted by this study and may help inform future regulatory decisions." @default.
- W4382182775 created "2023-06-28" @default.
- W4382182775 creator A5037269580 @default.
- W4382182775 creator A5046409408 @default.
- W4382182775 creator A5076085033 @default.
- W4382182775 creator A5088930878 @default.
- W4382182775 date "2023-06-27" @default.
- W4382182775 modified "2023-10-16" @default.
- W4382182775 title "A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia" @default.
- W4382182775 cites W2109314733 @default.
- W4382182775 cites W2346585285 @default.
- W4382182775 cites W2761792472 @default.
- W4382182775 cites W2889369542 @default.
- W4382182775 cites W2893793767 @default.
- W4382182775 cites W3127291294 @default.
- W4382182775 cites W4229040306 @default.
- W4382182775 cites W4251724550 @default.
- W4382182775 cites W4307027606 @default.
- W4382182775 doi "https://doi.org/10.1007/s40290-023-00483-x" @default.
- W4382182775 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37368166" @default.
- W4382182775 hasPublicationYear "2023" @default.
- W4382182775 type Work @default.
- W4382182775 citedByCount "0" @default.
- W4382182775 crossrefType "journal-article" @default.
- W4382182775 hasAuthorship W4382182775A5037269580 @default.
- W4382182775 hasAuthorship W4382182775A5046409408 @default.
- W4382182775 hasAuthorship W4382182775A5076085033 @default.
- W4382182775 hasAuthorship W4382182775A5088930878 @default.
- W4382182775 hasBestOaLocation W43821827751 @default.
- W4382182775 hasConcept C134448949 @default.
- W4382182775 hasConcept C144133560 @default.
- W4382182775 hasConcept C162324750 @default.
- W4382182775 hasConcept C162853370 @default.
- W4382182775 hasConcept C166957645 @default.
- W4382182775 hasConcept C17744445 @default.
- W4382182775 hasConcept C187736073 @default.
- W4382182775 hasConcept C2779652045 @default.
- W4382182775 hasConcept C39549134 @default.
- W4382182775 hasConcept C4438859 @default.
- W4382182775 hasConcept C71924100 @default.
- W4382182775 hasConcept C95457728 @default.
- W4382182775 hasConcept C98274493 @default.
- W4382182775 hasConceptScore W4382182775C134448949 @default.
- W4382182775 hasConceptScore W4382182775C144133560 @default.
- W4382182775 hasConceptScore W4382182775C162324750 @default.
- W4382182775 hasConceptScore W4382182775C162853370 @default.
- W4382182775 hasConceptScore W4382182775C166957645 @default.
- W4382182775 hasConceptScore W4382182775C17744445 @default.
- W4382182775 hasConceptScore W4382182775C187736073 @default.
- W4382182775 hasConceptScore W4382182775C2779652045 @default.
- W4382182775 hasConceptScore W4382182775C39549134 @default.
- W4382182775 hasConceptScore W4382182775C4438859 @default.
- W4382182775 hasConceptScore W4382182775C71924100 @default.
- W4382182775 hasConceptScore W4382182775C95457728 @default.
- W4382182775 hasConceptScore W4382182775C98274493 @default.
- W4382182775 hasIssue "5" @default.
- W4382182775 hasLocation W43821827751 @default.
- W4382182775 hasLocation W43821827752 @default.
- W4382182775 hasLocation W43821827753 @default.
- W4382182775 hasOpenAccess W4382182775 @default.
- W4382182775 hasPrimaryLocation W43821827751 @default.
- W4382182775 hasRelatedWork W2010478499 @default.
- W4382182775 hasRelatedWork W2024632604 @default.
- W4382182775 hasRelatedWork W2050011582 @default.
- W4382182775 hasRelatedWork W2051220639 @default.
- W4382182775 hasRelatedWork W2068005943 @default.
- W4382182775 hasRelatedWork W2071999521 @default.
- W4382182775 hasRelatedWork W2114034199 @default.
- W4382182775 hasRelatedWork W4317792299 @default.
- W4382182775 hasRelatedWork W1562604342 @default.
- W4382182775 hasRelatedWork W2085395339 @default.
- W4382182775 hasVolume "37" @default.
- W4382182775 isParatext "false" @default.
- W4382182775 isRetracted "false" @default.
- W4382182775 workType "article" @default.