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International Clinical Trials

Border Crossing

The investigational study of pharmaceutical and biotech products is now a global endeavour. With drug development necessitating material supply such as active pharmaceutical ingredients, and drug manufacture steadily moving from traditional markets to developing countries like China and India, we are witnessing a shift in geographies for the execution of clinical trials for investigational drug products.

In previous years, a multi-country study might typically include the US and developed European countries. This would require multi-language labelling and contending with the broad number of country-specific regulatory requirements, but was limited to a handful of countries with developed healthcare infrastructures to support study needs.

Today, investigational studies are spreading to many emerging markets, including Russia and eastern bloc countries, Latin American nations such as Brazil and Argentina, as well as Central America. There has also been a rise in studies in the Asia-Pacific region, where significant population growth and rapidly developing healthcare infrastructure in dense urban areas is conducive to clinical R&D.

Unique Countries

The Asia-Pacific region is attractive for investigational trials, but does come with risks and challenges depending on the geography of the study sites and the regulatory environment. For example, regulatory requirements in Japan can vary significantly to those in developing regional neighbours such as South Korea, China, Taiwan, Singapore, the Philippines and Malaysia. Each distinctly unique country needs to be evaluated independently for its advantages, regulatory landscape and logistical risk.

Japan possesses an extremely developed healthcare system. It also features a densely populated grouping of cities, making it very attractive for recruiting and administering clinical studies. Costs can be relatively high, but the quality of study data is reliable and infrastructure advanced.

Companies looking to execute clinical studies in Japan can expect longer lead times for regulatory approval, in comparison to neighbouring countries. Longer timelines for import clearance for bringing investigational materials into the country should be included in a sponsors’ planning phase.

At the time investigational products are planned to be shipped, companies need to be exacting in their paperwork to ensure smooth and timely processing of orders and importing of materials. Using a partner that is familiar with the approval process and has a local presence may be beneficial.

China Characteristics

Conversely, China is an area opening up to study for investigational medicines that has very different characteristics. A nation of some 1.35 billion people spread across a geography of 3.8 million square miles, it features close to 150 cities with a population density of 1 million inhabitants or greater. However, China ranks 144th in the world in quality of healthcare, which is indicative of its developing nation status. Quality of healthcare can vary regionally as well, particularly between urban and rural areas.

China, like many of the developing Asia-Pacific countries, is working to make changes to its laws to make investigational studies easier. Sponsor companies can expect application processing to take five to nine months for approval, and importation logistics can prove challenging.

Weighing the Risks

Intellectual property rights can also be a concern for companies. Like that of China, other Asia-Pacific countries – such as Taiwan, Malaysia, South Korea, Singapore and the Philippines – feature rapidly advancing healthcare systems as the standard of living steadily increases.

These countries offer much smaller geographies for distribution of investigational products, but many of the same unique country-specific policies and regulations need to be properly accounted for, in terms of logistical planning, supply considerations and cost.

As with many of the emerging market geographies, there can be many advantages with doing business in the Asia- Pacific region if sponsor companies properly weigh the risks and logistical challenges. With the advances in economic prosperity, quality of healthcare and rapid penetration of technology in the region, it is safe to assume this will be an increasingly popular study region for years to come.

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Rich Nelson is the Distribution Services Manager for PCI’s North American Clinical Services group, working with clients to provide seamless global distribution for their investigational products. Rich joined PCI in 2012 after seven years with Fisher Clinical Services.
Rich Nelson
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