China

Government
Socialist people’s republic
Official Languages
Standard Chinese

Geography
Located in Southeast Asia along the coastline of the Pacific Ocean, China is the world’s third largest country, after Russia and Canada. With an area of 9.6 million square kilometers and a coastline of 18,000 kilometers, its shape on the map is like a rooster. It reaches Mohe in Heilongjiang Province as its northern end, Zengmu Ansha (or James Shoal) to the south, Pamirs to the west, and expands to the eastern border at the conjunction of the Heilongjiang (Amur) River and the Wusuli (Ussuri) River, spanning about 50 degrees of latitude and 62 degrees of longitude. China is bordered by 14 countries — Korea, Vietnam, Laos, Burma, India, Bhutan, Nepal, Pakistan, Afghanistan, Tajikistan, Kyrgyzstan, Kazakstan, Mongolia, and Russia. Marine-side neighbors include eight countries — North Korea, Korea, Japan, Philippines, Brunei, Indonesia, Malaysia and Vietnam.

Demographics
Population:  1.42 billion (2018)
Sex Ratio:
Ethnic Groups:
  • Han 91.5 %
  • Zhuang 1.3%
  • Manchu 0.86%
  • Uygur 0.79%
  • Hui 0.79%
  • Miao 0.72%
  • Yi 0.65% Yi
  • Tujia 0.62%
  • Mongol 0.47%
  • Tibetan 0.44%
  • Buvei 0.26%
  • Other 1.05%

Although 56 different ethnic groups are officially recognised in China, 91.51% of Chinese are Han Chinese. Only one other group “Zhuang” has a larger than 1% share of the population.
Life Expectancy:
Male: 75.01 years Female: 78.08 years

Infant Mortality Rate: 10.036 deaths/1,000 live births

Diseases with the highest prevalence

  • Cardiovascular diseases
  • Neoplasms
  • Chronic respiratory diseases
  • Diabetes
  • Urological
  • Hematological diseases
  • Endocrine diseases
  • Neurological disorders
  • Unintentional injuries
  • Diarrhoeal diseases
  • Cirrhosis

Clinical Research Related Information

Regulatory Authority: Chinese Food and Drug Administration (CFDA)
International trials proposed for China must have at least three other countries involved.
The drugs must have already been approved in a Phase I or Phase II trial elsewhere. CFDA may nevertheless require conducting a Phase I trial in China first.
If the drug to be used in the trial is being imported, an import license will be required.
CFDA has consistently held up approval of import applications until the drug obtains marketing approval at least in the country where the manufacturer is located
China imposes minimum populations for clinical trials depending on the particular category for the drug

Average time for CFDA approval: 12- 18 month
Assuming CFDA approval must be obtained before EC (rather than in parallel), expect 18 -24 months to obtain all approvals for a global clinical trial.

Ethics Committees
Ethical review of research involving human and animals is done by “institutional ethics committees” of hospitals, medical colleges, and research institutions.
All documents have to be submitted in Simplified Chinese.

Why China for clinical trials?

  • China has the world’s largest population
  • Increasingly important biopharmaceutical consumer market
  • Low operational costs
  • The Chinese government has a strong commitment to research