Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion, including drug failures. With the increased demand for rare/life-saving drugs, the Market Authorization Application (MAA) filings are also increasing. A disparity between supply-chain operations and manufacturing processes has led to disconnected systems. Lack of coordination within various departments (clinical science, chemistry, manufacturing, and controls (CMC), nonclinical, pharmacokinetics, pharmacodynamics, medical writing, and clinical operations) has compromised the quality of product information escalating the risk of non-compliance in submissions.
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Highlights of the Self-Testing Provision for Medical Devices in China