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The definition of non-biological complex drugs (NBCDs) is not officially recognized, and there is no corresponding term, in the European Union (EU) pharmaceutical legislation or scientific guidance. Despite this, authors Falk Ehmann and Ruben Pita argue in their personal capacity that the existing EU legislation and guidance is equipped to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of such a group of medicinal products [1]. While agreeing with most of Ehmann and Pita, a number of experts from the Steering Committee members of the NBCD Working Group pointed out that there are still many unknowns when it comes to NBCDs [2].
- INICIO
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Investigación
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
General
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay
- FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
- FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
- ANVISA aprueba cuatro biosimilares para denosumab, trastuzumab y aflibercept
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