Recent trends and special topics in new drug review in PMDA
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 2
Abstract
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory agency, which works together with the Ministry of Health, Labour and Welfare. At the 24th Drug Information Association Annual EuroMeeting in March 2012, PMDA presented an overview of recent trends and special topics in new drug review. Here, the current status and trends are highlighted, and the new drug review is discussed.
Authors and Affiliations
Toshiki Sugita
Keywords
Related Articles
- EP ID EP355051
- DOI 10.5639/gabij.2013.0202.024
- Views 86
- Downloads 0
Biosimilarity of anticancer monoclonal antibodies in the clinic
The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, con...
Biosimilars naming and prescribing policy in Australia
To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and pr...
Rhythm
Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are asso...
The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation
Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself. Objective: The o...
Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased ris...