Case Study: Identifying Opportunities in the Drug Registration and Reimbursement Approval Process

July 3, 2014

Brief:

Our client faced delays in China’s new drug registration and reimbursement approval process and wanted to reduce time-to-market for new products.

Emerging Strategy’s Solution:

Emerging Strategy conducted detailed interviews with our client’s regulatory affairs staff in China to learn about specific bottlenecks at various stages of the process. To gain a clear understanding of pain points and how to address them, we mapped the entire registration and reimbursement approval process, including key stakeholders. We interviewed regulators in departments. responsible for registration and reimbursement to understand their attitude to various disease areas, and to identify attitudes or policy changes that may affect our client. We interviewed health care professionals and key opinion leaders within the medical community to understand perspective and support for various drug categories and therapies when state drug registration authorities turn to them for expert advice. We also assessed the experience and time optimization methods used by other foreign pharmaceutical companies.

Result:

The client relied on analysis as decision support tool for optimizing their registration process, what new products and disease areas would be received favorably by Chinese regulators, and tactics for listing as reimbursable drugs.



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