Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

China has established its Chinese Traditional Medicine system for thousands of years, and there was no clinical trial at all before the western drug was introduced in China in recent 100 years. China GCP was introduced in 1998 by MOH and its revised version was introduced in 1999 by SDA (called SFDA from 2003).

China has attempted to streamline its regulation and align the country with international standards of practice; as a result, the country's legal system governing pharmaceutical research, production, and marketing was modified substantially recent years. One of the examples is that the MOH issued the first version of GCP in 1998. After the establishment of the SDA (now SFDA, State Food and Drug Administration), SFDA formally issued its GCP September 1, 1999, after ten years of work, and the latest version of GCP was issued in 2003 after the new Drug Administration Law went into effect in 2001, and the new Drug Registration Procedure went into effect in 2002. Clinical trial activity in China is on the rise. And also in accordance with requirements of the World Trade Organization (WTO).

China is expected to be the fourth largest pharmaceutical market by 2010, and the average growth rate of China market kept more than 15% since 1978, so is it possible to the conduct trials in China? what are the main challenges to conduct trial in China? What are the strategies to conduct trial in China? In addition, if the sponsor would like to select a CRO in China, how to select?

2002 was a milestone year in China for the promulgation of laws to improve intellectual property protection of pharmaceuticals. For example, as part of China's WTO accession, Chinese authorities promulgated legislation extending all patent coverage to 20 years. Other improvements include provisions for data protection and patent linkage. This is good news for foreign companies that want to introduce new drugs to China.

There are lots of advantages for conducting multinational clinical trials in China: fast patient recruitment, low cost, large patient pool, abound, unique disease resources, experienced and motivated investigator, huge market, shortening the time to market a new drug, GCP compliance database and China government policy adjustment favorable to foreign companies.

China has attempted to streamline its regulations and align the country with international standards of practice. A set of new drug regulations were introduced in 2002, and in mid-2003 more changes were brought in by China SFDA. While some changes are intended to shorten approval timelines, many introduce obstacles into the approvals process. Changes have been aimed at shrinking evaluation timelines to 120 working days, and from Oct 2007, it will be 90 working days. At the same time, China has adjusted the policy of multi-center clinical trial since December 2002.

Since February 19, 2004, SFDA issued a regulation, stating only GCP-certified sites are authorized to conduct clinical trials. At present, 80% of medical resources are allocated in big cities, and 30% of these resources are focused in large hospitals. As a result patient treatment of major maladies is centralized to major hospitals. There are 1.3 billion people in China in 2005. With the first population in the world, China is a country with abound, unique clinical resource, and the adequate patients can make manufacturers to recruit subject in a short time.

The cost of conducting clinical trials in China is relatively low, especially for the lab cost, PI grant and CRA traveling.

So with the establishment of China SFDA, strengthening IPR protection, and regulation environments improvements, more and more multinational clinical trials are introduced in China since 21st century,

Although there are so many benefits to conduct clinical trail in China, there are still lots of challenges for conducting multinational clinical trial in China, such as lengthy approval process for clinical trial, restrictive export of whole blood/DNA, unclear investigator's accountability, quality issue, insufficient training, Lack of qualified/experienced CRAs and project managers, limited logistic support, and local practice, culture, language barrier.

Considering China pharmaceutical regulation compliance with the international standards, great potential market in China, more and more international clinical trial are introduced in China, however, because of the short history of multinational clinical trial in China and there are still some local practices different with the international, so the multinational companies has to learn the local know-how, otherwise, sponsors who lack of such capabilities can access China with the assistance of contract research organizations (CROs).

Previously, it will take 7-9 months to get the regulatory approval from SFDA, which is one of the major complain of the global sponsor to China is the lengthy regulatory review approval process, however, it will be changed from Oct, 2007. Since the regulatory review approval process will be shortened to 90 working days, so it will bring further opportunities to the global pharmaceutical companies.