2022-08-16
Bridging Study Evaluation Preparation and Application
The EffPha team is composed of highly trained scientists and experienced scientific directors who have a great understanding of the health authority’s expectations.
A leading global pharmaceutical company approached EffPha seeking assistance in preparing and submitting a Bridging Study Evaluation (BSE) application in Taiwan.
The Challenge
The client sought the approval of their oncology drug in Taiwan. The drug has been approved in the US and is expected to gain EMA approval the following year.
However, only a limited number of subjects from Taiwan were enrolled in their multi-regional pivotal trial, but conducting a bridging study in Taiwan to meet the regulatory requirements will be costly and time-consuming. The client intended to use the existing data to support the Bridging Study Evaluation (BSE) application and the marketing application submission.
The challenge lies in preparing a strong BSE application package by extracting crucial information from the complete clinical data package (CCDP) to address the regulatory requirements and facilitate decision-making.
The Solution
After analyzing the data in the CCDP, PK reports, and European Research Area (ERA) reports, the EffPha team worked with the client to develop a strategy for preparing the BSE report.
Knowing that an ongoing clinical trial is being conducted in China, we suggested the client summarized the subgroup analysis results in the Chinese, Asian and non-Asian populations. The analyses showed no significant intrinsic or extrinsic ethnic differences in PK, safety, and efficacy and provided evidence that the existing data are applicable to the population in Taiwan.
Results
With our assistance, a bridging study waiver was granted by the Taiwan Food and Drug Administration (TFDA). The client then proceeded quickly to the New Drug Application (NDA) submission, speeding up the time to market in Taiwan.
A leading global pharmaceutical company approached EffPha seeking assistance in preparing and submitting a Bridging Study Evaluation (BSE) application in Taiwan.
The Challenge
The client sought the approval of their oncology drug in Taiwan. The drug has been approved in the US and is expected to gain EMA approval the following year.
However, only a limited number of subjects from Taiwan were enrolled in their multi-regional pivotal trial, but conducting a bridging study in Taiwan to meet the regulatory requirements will be costly and time-consuming. The client intended to use the existing data to support the Bridging Study Evaluation (BSE) application and the marketing application submission.
The challenge lies in preparing a strong BSE application package by extracting crucial information from the complete clinical data package (CCDP) to address the regulatory requirements and facilitate decision-making.
The Solution
After analyzing the data in the CCDP, PK reports, and European Research Area (ERA) reports, the EffPha team worked with the client to develop a strategy for preparing the BSE report.
Knowing that an ongoing clinical trial is being conducted in China, we suggested the client summarized the subgroup analysis results in the Chinese, Asian and non-Asian populations. The analyses showed no significant intrinsic or extrinsic ethnic differences in PK, safety, and efficacy and provided evidence that the existing data are applicable to the population in Taiwan.
Results
With our assistance, a bridging study waiver was granted by the Taiwan Food and Drug Administration (TFDA). The client then proceeded quickly to the New Drug Application (NDA) submission, speeding up the time to market in Taiwan.