Pediatric drug development - Regulatory challenges and commercial opportunities
|出版商||CBR Pharma Insights||商品編碼||312351|
|出版日期||內容資訊||英文 64 Pages
|兒童用醫藥品的開發:法規方面的課題與商業方面的機會 Pediatric drug development - Regulatory challenges and commercial opportunities|
|出版日期: 2014年07月31日||內容資訊: 英文 64 Pages||
Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).
Since the introduction of pediatric legislation there has been a substantial investment in pediatric research and the number of clinical trials performed in children has increased significantly. In the US more than 350 product labels include new pediatric information and more than 130 products have undergone a pediatric focused post-labelling safety review. In Europe there has been 221 changes regarding the safety and efficacy of medicines from the submission of old or new studies in children and 89 additions of dosing information for children as a direct consequence of Paediatric Investigation Plans (PIPs).
Despite the apparent success of the pediatric regulation, the submission of pediatric information is complex and the incentives are often insufficient to encourage industry innovation (Rose & Della Pasqua, 2011). No new drugs can be registered in the EU without a detailed PIP being approved by the EMA's Pediatric Committee (PDCO) (Rose, 2014). Without a PIP, the registration process for a new drug can be blocked. In the US, the FDA has adopted a more pragmatic approach to pediatric drug development, providing voluntary and mandatory routes for pediatric evaluation.
Many experts agree that there is significant room to improve the EU pediatric regulations and a revision of the legislation is scheduled to take place in 2018. In the meantime, there is considerable potential for the industry to develop pediatric formulations and doses of approved and generic medicines, particularly for use in transition countries where access to high quality pediatric formulation is improving. In addition, new commercial opportunities exist to develop medicines that target pediatric specific conditions in neonates as well as rare and neglected diseases and pediatric vaccines.