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T-38: Agencies Strategies to Enhance the Review Efficiency of IND for Human Cell Therapy Products in Taiwan

Poster Presenter

Meng Ting Tsai

Project Manager
Center For Drug Evaluation (CDE)
Taiwan

Objectives

The goal of this study is to investigate the effect of agency strategy on review procedure and capability for clinical trials of human cell therapy products in Taiwan.

Method

1. Collected official announcements related to Cell Therapy Products from 2010 to 2018. 2. Retrieved data of review procedures of IND from CDE E-management Database. 3. The study period was divided into three stages according to policy activities. All data collected were analyzed by Microsoft Excel.

Results

In Taiwan, Center for Drug Evaluation (CDE) is commissioned by Taiwan Food and Drug Administration (TFDA) to evaluate the technical dossier of IND and NDA given recommendation for approval. Basically, the technical dossier of IND for pharmaceutical products is reviewed by review team on CDE. After receiving the review report, TFDA may consult with Advisory Committee to give final conclusion then send to applicant. In recent years, TFDA has set up strategies to enhance the access of medicinal product for advance therapy. Hence some policy actions were carries out for the review of cell therapy. Accordingly, development of the review procedure can be divided into three milestones: Stage I (2010- August 2014): TFDA consulted with Advisory Committee (for pharmaceutical product in general) every IND application for human cell therapy products after received review report by CDE. The official review time (from application to the approval/rejection) was found to be 162~305 days in this stage. Stage II (September 2014 to September 2018): TFDA established Regenerative Medicine Advisory Committee (RMAC), in which most members were cell therapy experts and scholars from medical centers and universities. In this stage, every such clinical trial protocol reviewed by CDE had been consulted with RMAC. Moreover, the official review time was reduced to 132~223 days. Stage III (September 2018 to present): The review procedure is adjusted by TFDA after reviewed the consistency of recommendation by CDE and by RMAC. In this stage, only cases with certain medical or ethical concerns on recommended by CDE will consult with RMAC. The official review time further reduced to less than 100 days at stage III. The results indicate that the trend of gradual improvement of review efficiency. In addition to the revision of review procedure, TFDA and CDE also co-established prior assessment consultation for cell therapy products in 2014, to enhance the application quality for IND submission.

Conclusion

The establishment of review capabilities requires the accumulation of review experience over time, consensus building with experts in the field outside the agency, support by policy and improvement of application quality. In particular, TFDA has taken the role develop policy activities to benefit the product development of advance therapy in Taiwan.