Why is Race conducting trials in Australia, South Korea and Hong...

Why is Race conducting trials in Australia, South Korea and Hong Kong, testing the waters before heading US, Japan and US (respectively)?




Yes, conducting clinical trials in South Korea can often be seen as a "foot in the door" to Japan, and in some cases, it may be more effective than conducting a trial directly in Japan. Here are a few reasons why a South Korean trial might provide a strategic advantage for market entry into Japan:

1. Regulatory Alignment and Mutual Recognition

South Korea and Japan are both members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This means that clinical trials conducted in South Korea are often held to similar regulatory and ethical standards as in Japan. The data generated from South Korean trials is typically considered reliable and may be accepted by Japanese regulatory authorities, simplifying the approval process for entering the Japanese market.

2. Faster and More Efficient Regulatory Approval

South Korea's regulatory environment for clinical trials is known for being faster and more efficient than Japan’s. Japan's Pharmaceutical and Medical Devices Agency (PMDA) has a reputation for being cautious and sometimes slow, particularly for new or foreign companies. By first conducting trials in South Korea, companies can generate clinical data faster, which can then be used to support an application in Japan, potentially speeding up the overall approval timeline.

3. Cost Advantages

Clinical trials in Japan are often more expensive due to higher operational costs, including site fees, investigator costs, and patient management. South Korea, while maintaining high-quality clinical trial standards, generally offers lower costs, making it an attractive option for companies with limited resources who want to generate data that can be used in Japan.

4. Cultural and Demographic Similarities

South Korea and Japan share some cultural, demographic, and medical practice similarities, especially in healthcare standards. This makes South Korean clinical trial results more applicable or easily translatable to the Japanese population, reducing concerns over geographical or demographic discrepancies.

5. Gateway to Broader Asia-Pacific Market

Successfully conducting a trial in South Korea can act as a broader entry point into the Asia-Pacific region, including Japan. It may also help in forming regional partnerships or collaborations, further easing market entry into Japan.

6. Less Regulatory Burden for Early-Stage Data

In Japan, companies often face substantial regulatory and administrative burdens for clinical trials, especially for early-stage data generation. By conducting early-stage or proof-of-concept trials in South Korea, companies can sidestep these early regulatory hurdles in Japan and approach the PMDA with more comprehensive data, thereby reducing delays in Japan.

7. Expedited Conditional Approvals

Japan has a growing interest in accepting overseas data to expedite the approval of certain drugs, especially for unmet medical needs. South Korea’s high-quality clinical trial system makes it easier for the PMDA to accept data from South Korean trials, which could lead to faster conditional approval or even bridging studies in Japan.

8. Strategic Partnerships

South Korea is seen as a technology and research hub in Asia, and conducting trials there may help build relationships with Japanese pharmaceutical companies, contract research organizations (CROs), or healthcare providers, facilitating later trials or market entry in Japan.

When Japan-Only Trials May Be More Effective

While a South Korean trial can serve as an effective gateway to Japan, there are situations where conducting a trial directly in Japan might be more advantageous:

• Regulatory Exclusivity in Japan: Some drugs may benefit from Japan-specific incentives, such as special designations for rare diseases or orphan drugs, which might only be available if trials are conducted directly in Japan.
• Direct Market Relevance: If the drug or treatment is highly specific to the Japanese population or disease prevalence in Japan, conducting a local trial could be more persuasive for both regulatory bodies and the market.

Conclusion

In many cases, South Korean trials can be an effective, faster, and more cost-efficient way to generate clinical data that is valuable in Japan, helping companies overcome the often complex and costly hurdles of directly entering the Japanese clinical trial landscape.