China's growing economic strength and population of 1.3 billion people holds tremendous potential for global pharma and biotech companies as a location for clinical trials, as well as a market for novel therapies. With low costs of labor and infrastructure and cost per patient, it is also the second largest CRO market and a hotbed of mergers and acquisitions, deals and partnerships, many of which are between multinationals and local CROs. Recent pharmaceutical mergers and acquisitions in the market by foreign companies have also increased the number of pharmaceutical manufacturers in China. With growing R&D capabilities and resources and increasing number of sites for clinical trials, it has attracted many. However, along with this tremendous potential, there are a number of important challenges that should be considered.

One of the major challenges is the time it takes to receive regulatory approval for a clinical trial. On an average, it currently takes nine-to-ten months and another one-to-two months for ethics approval. In Hong Kong, the review process takes around two months and a parallel IRB/regulatory application can also be made. Despite this lengthy regulatory approval, attempts are being made by the Chinese government to streamline its regulations and align the country with international standards of practice but this aspect will remain a constraining factor for many sponsors for some time.

The growing importance of centralized laboratories for patient sample analysis will present as another challenge for sponsors of clinical trials as the export of whole blood and tissue samples requires that a sponsor must apply for an export permit for each shipment a process that can take weeks. Although these restrictions have been eased in recent months, the process still remains difficult. This burdensome export process poses a substantial but not insurmountable drawback for clinical trial programs, but could be overcome if sponsors are prepared to work with established, accredited central laboratories based in China.

China has an international reputation for patent and intellectual property rights violations across all industries. Counterfeiting of almost every product is still a major problem, despite attempts by the Chinese government to tackle the problem. A not uncommon scenario is that an overseas company could find that it is competing for sites and patients with one or more local Chinese companies who are developing a generic version of the overseas company? own patent-protected drug! Therefore, the importance of taking out as much local patent protection as possible before embarking on trials in China cannot be stressed enough.

Etiquette is vitally important in China. Therefore, for small companies without resources in China, it is important to work with an organization that is based in China and understands both ICH GCP and China SFDA GCP requirements is very important for ensuring clinical trial integrity and success. ‘Guanxiis the concept of contacts and networks and as such it is considered to be very important to establish close contacts with people in government or quasi-government bodies.