Country Specific Regulations – Global / International Trial

As more and more clinical trials become globalized, regulatory pathways in different region and countries represent both opportunities and limitations in the continuation of this trend. One important point to bring up in global trial discussion is that outside of the European Union (EU), there is no harmonization of regulatory requirements among each country. Thus, country specific regulatory requirements are the rules governing clinical trial conducts and final product approvals.

Commercial Opportunities

Developing countries represent significant opportunities due to the large size of population (potential buyers of the product) in different regions of the world. In addition, the size of the market in some regions is growing rapidly. For example, Asian pharmaceutical market is already substantial, second only to that of North America. China, alone, is growing rapidly due to its vast population.

Non-Commercial Opportunities

In addition to commercial potential, developing countries also present non-commercial opportunities such as access to:

New patient / disease populations
New clinical trial sites
Key opinion leaders (KOLs)
New regions with potentially lower clinical trial cost

Consideration for Global Trial Site Selection

When considering global / international clinical trial site(s), manufacturers must consider the factors below:

Which countries should (and should not) be included in global development plans
When these countries should be involved, as each country requires different timelines for clinical trial approvals, completion, and regulatory and reimbursement decisions
How the manufacturer should be involved in the end market use of the product in these countries. Examples include how the end product will be distribute, the cost of the product, and the unmet need in different countries