Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework.
pharmaceutical approval
pharmacotherapy
regulatory guidance
type 1 diabetes mellitus
type 2 diabetes mellitus
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
pubmed:
5
9
2018
medline:
17
3
2020
entrez:
5
9
2018
Statut:
ppublish
Résumé
The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union. Information about approved antidiabetic drugs was obtained by searching databases of regulatory authorities in the 3 regions. Other relevant information was also obtained from publicly available literature and documents. No difference in the total number and types of approved drugs among the 3 regions was found ( Antidiabetic drug development in Japan costs less than that in the other regions, although novel development is less active because of regulatory differences. To achieve better pharmacotherapy for diabetes, the regulatory framework requires careful consideration.
Sections du résumé
BACKGROUND
The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union.
METHODS
Information about approved antidiabetic drugs was obtained by searching databases of regulatory authorities in the 3 regions. Other relevant information was also obtained from publicly available literature and documents.
RESULTS
No difference in the total number and types of approved drugs among the 3 regions was found (
CONCLUSION
Antidiabetic drug development in Japan costs less than that in the other regions, although novel development is less active because of regulatory differences. To achieve better pharmacotherapy for diabetes, the regulatory framework requires careful consideration.
Identifiants
pubmed: 30176740
doi: 10.1177/2168479018795854
doi:
Substances chimiques
Hypoglycemic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM