Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Clinical Trials in China

Anneke Hackling (Abschlußjahr: 2007)

Language: English

China has been rapidly rising as an attractive clinical research location for international pharmaceutical companies in the last 10 years. Chinas drug market is one of the top ten drug markets around the world and constantly increasing. Clinical trial data obtained from Chinese population is a requirement for a medicinal product marketing authorisation and, thus, a prerequisite for the access to the emerging Chinese health economy.

Moreover, off shoring clinical trials to China is a favourable option for an international pharmaceutical company to significantly reduce the developmental costs for a new drug.

Chinas regulatory environment is under constant development, and the legal system governing pharmaceutical research, production and marketing has been substantially modified. The country has been working on streamlining regulations and aligning itself with World Trade Organization requirements and international standards of clinical practice. Adapted to the ICH Good Clinical Practice (GCP) Guideline, the Chinese GCP regulation is effective since 1September2003. The Chinese State Food and Drug Administration (SFDA) has introduced new procedures designated to improve the transparency of drug regulatory procedures and reduce opportunities for corruption. Nevertheless, a clinical trial application at SFDA and the concerned Ethic Committee still is a very complex and time consuming procedure requiring comprehensive documentation in Chinese.

Cost-efficiency is the most prominent driver behind the increasing numbers of international clinical research activities in China. Due to significantly lower salaries and infrastructure costs, conducting clinical trials in China can save operational costs in the range from 30 to 65 percent compared to Western countries.

1.3 billion Chinese build a large patient population. The ease of patient recruitment is additionally favoured by the centralisation of patients to large hospital centres for treatment of major maladies. As China is a developing country, Chinese patients tend to be more treatment naïve than in Western untries.

Clinical trials in China should only be conducted at sites designated by SFDA and with a current GCP certificate, which is not always congruent. A pivotal role in conducting a trial is attributed to the principle investigator, who not only operates patient enrolment but also has profound influence on the implementation of regulations and standards.
The revised Chinese regulatory legislation provides a stringent legal framework for conducting clinical trials. But due to the inexperience of the regulatory environment, the de facto implementation of international GCP standards remains to the final responsibility of the sponsor.

Especially for larger international pharmaceutical companies, building up local R&D cooperations is an option to bring clinical trial facilities in China up to international standards and to improve the quality of clinical trial results and data.
With benchmarking to international standards, clinical trial data from China has a clear perspective to be accepted by the US FDA and the European EMEA.

Despite all official activities, international pharmaceutical companies doing business in China often suffer from the sporadic enforcement of intellectual property rights. But recent decisions in patent infringement cases can be characterised as a sign of Chinas improving attitude towards intellectual property rights protection.

Conducting clinical trials in China should not only be seen as a necessary prerequisite for a marketing authorisation and for access to the emerging Chinese drug market, but also as an option to contribute to the international development of a new drug with low-cost but adequate quality clinical data.

Pages: 52