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T-26: Prior Assessment Consultation for Cell Therapy Products to Enhance the Investigational New Drug Application Quality in Chines Taipei

Poster Presenter

Yu-Chun Teng

Project manager
TFDA/Center for Drug Evaluation, Taiwan
Taiwan

Objectives

The goal of this study is to analyze whether the implementation of prior assessment consultation for cell therapy products, which established in 2014, can enhance the quality of IND application, and further expedite Taiwan CDE review process and improve review efficiency.

ORAL PRESENTATION: 12:40PM

Method

We collected and analyzed the IND applications of cell therapy with agency review concluded during 2010 to 2017. Data of IND deficiencies, supplement time, approval rate and overall review time will be compared for cases with and without prior assessment consultation provided by Taiwan CDE.

Results

Taiwan CDE has reviewed the dossiers of IND of cell therapy since 2010. We developed a procedure for prior assessment consultation for cell therapy in 2014, and offered advice to applicants for IND package preparation. The prior assessment consultation includes 3 stages: preliminary review (CDE report provided within 20 days), substantive review (CDE report provided within 60 days), and final review (CDE report provided within 30 days). For those cases applied for prior assessment consultation, 100% meet the time criteria stated in SOP. During 2014 to 2017, there were 37 cases that applied for prior assessment consultation, in which 21 cases have submitted IND, 3 cases have not after consultation, and 13 cases have been advised to a general consultation due to too many deficiencies in dossiers. A total of 71 IND submissions of cell therapy during 2010 to 2017 were collected. Fifty four applications have completed IND review, in which 42 applications have granted “Safe to Proceed”, and 12 applications have granted “Clinical Hold”. Among the 54 applications with agency review concluded, 20 applications have applied prior assessment consultation. We divided the IND applications with agency review concluded into two groups. Group A is the IND application without prior assessment consultation, while Group B is the IND application with prior assessment consultation. Compare with Group A and Group B, we summarized some analysis below: (1) The average number of IND deficiencies of Group A (27) is higher than Group B (16). (40.7% deficiencies reduced) (2) The average supplement time of Group A (68 days) is longer than Group B (44 days). (35.2% supplement time shortened) (3) The IND approval rate of Group A (70%) is less than Group B (95%). (25% approval rate increased) (4) The average review time of Group A (15 months) is longer than Group B (6 months). (60% review time shortened)

Conclusion

Taiwan CDE aims to assist the development of biopharmaceutical industry and public health in Taiwan. Prior assessment consultation facilitates the communication between the regulatory agency and the industry. Therefore CDE is able to satisfy the industry’s demand for regulatory science. A well-organized prior assessment consultation for cell therapy can assist applicants to schedule the formal IND filing. Prior assessment consultation is a beneficial mechanism to assist applicants preparing IND package, enhance the quality of IND submission, and further improve IND review efficiency.