CDx Registration in Korea, Taiwan, Singapore, Australia, and the Other Asian Markets

Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of their drug products more effective. Precision or personalized medicine will grow in Asia via CDx’s in the future.

CDx regulations in Asia are still in the early stages of development. For example in 2018, Korea published its first regulation for a CDx product with a drug. Also in 2018, Australia announced its first CDx regulations including the classification of a CDx product and how it should be registered with a drug.

Similarly, reimbursement for CDx products is not available or very low in Asia today. For example, in Korea, the reimbursement agency HIRA provides a low level of reimbursement for some CDx products, whereas no reimbursement is available in Taiwan.

Moreover, many Asian doctors are not familiar with CDx tests and their real value.

Going forward as CDx’s become more well-known globally and helpful with selecting the right patients for specific disease treatments, CDx registration in Asia will increase. Asian regulators and reimbursement agencies will continue to develop new regulations as precision medicine becomes more popular in Asia.

PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more.