China’s $22.5 billion pharmaceutical market is the second largest in Asia, after Japan, and foreign drug imports and pharmaceutical investment in China will likely increase as China enters the WTO. Anticipating an influx of foreign pharmaceuticals, the Chinese government established the State Drug Administration (SDA) in March 1998, an organization created to oversee drug importation through law and inspection.
The SDA consolidates the former State Pharmaceutical Administration of China (SPAC), the Bureau of Drug Policy Administration (BDPA) and the State Administration of Traditional Chinese Medicine (SATCM). The organization’s goals are to streamline the enforcement and inspection processes, as well as to “clean up” China’s domestic medicine market to increase its competitiveness for China’s WTO accession. The SDA has authored several revised regulations since its conception, including the “Provisions for Import Drug Approval.”
China’s Ministry of Health (MOH) is the agency responsible for public health and welfare issues in China. Under the leadership of Minister Zhang Wenkang, the MOH is responsible for: drafting laws, regulations, plans and policies with regard to public health; implementing disease prevention and treatment programs; directly overseeing 34 State hospitals; reforming medical institutions; supervising blood collection; setting quality standards; training health experts; and the like.
MOH plans and programs had significant success in the early years. Life expectancy increased from 35 years in 1949 to 70 by the 1990s, and significant gains were made in infant mortality and immunization. However, China’s health care system has begun to show signs of strain. Between 1978 and 1987, government spending on medical care increased 28 fold and became unsustainable. The increase was due to a variety of factors, including longer life spans (diseases of older people are difficult and expensive to treat) and an increase in unhealthy lifestyles. To deal with rising costs, the MOH has cut drug prices, separated hospital pharmacies from hospitals, and instituted other reforms. Additionally, the MOH has announced that within the next two years, medical service organizations will be divided into for-profit and nonprofit units, presumably increasing competition and therefore lowering costs.
The SDA consolidates the former State Pharmaceutical Administration of China
(SPAC), the Bureau of Drug Policy Administration (BDPA) and the State Administration
of Traditional Chinese Medicine (SATCM). The organization’s goals are
to streamline the enforcement and inspection processes, as well as to “clean
up” China’s domestic medicine market to increase its competitiveness for
China’s WTO accession. The SDA has authored several revised regulations
since its conception, including the “Provisions for Import Drug Approval.”
China’s Ministry of Health (MOH) is the agency responsible for public health and welfare issues in China.
Under the leadership of Minister Zhang Wenkang, the MOH is responsible for:
drafting laws, regulations, plans and policies with regard to public health;
implementing disease prevention and treatment programs; directly overseeing
34 State hospitals; reforming medical institutions; supervising blood collection;
setting quality standards; training health experts; and the like.
MOH plans
and programs had significant success in the early years. Life expectancy increased
from 35 years in 1949 to 70 by the 1990s, and significant gains were made in
infant mortality and immunization. However, China’s health care system
has begun to show signs of strain. Between 1978 and 1987, government spending
on medical care increased 28 fold and became unsustainable. The increase was
due to a variety of factors, including longer life spans (diseases of older
people are difficult and expensive to treat) and an increase in unhealthy lifestyles.
To deal with rising costs, the MOH has cut drug prices, separated hospital pharmacies
from hospitals, and instituted other reforms. Additionally, the MOH has announced
that within the next two years, medical service organizations will be divided
into for-profit and nonprofit units, presumably increasing competition and therefore
lowering costs.