Brief introduction to priority medicines scheme in European Union and its inspiration for China
To accelerate the development and market launch of new drugs that address unmet clinical needs,the European Medicines Agency(EMA)launched the"priority medicines(PRIME)"scheme in 2016.A range of supportive measures have been provided to drugs granted this qualification at various stages of development,including the appointment of dedicated personnel from EMA to assist applicants,multiple opportunities for applicants to engage in dialogue with regulatory authorities at key developmental stages,assistance in formulating or adjusting drug development plans and regulatory strategies,and facilitating the transition from drug development to market authorization review,thereby expediting the approval process for drug market applications.As of the first half of 2021,EMA had received a total of 384 PRIME qualification applications,of which 95 were approved,covering 19 therapeutic areas including antineoplastic medications,hematological medications,neurological medications,etc.It is suggested that relevant departments in China may draw on the practices of EMA to strengthen the construction in project management,management of communication and exchange meetings,utilization of review resources,and quality management of the review process,in order to improve the system for breakthrough therapeutic drugs in China.
万方数据
维普
