The vaccine safety problem that has occurred in China recently highlights the ineffectiveness of China’s drug regulatory system. At present, since China supplies 40 percent of world’s pharmaceutical raw materials, the international community has begun to question its drug quality. The Central News Agency reported that, in 2017, the value of pharmaceutical raw materials that China exported was US$29 billion. Their customers included Teva Pharmaceutical, Johnson & Johnson, and Novartis. It is estimated that 80 percent of the pharmaceutical raw materials used by U.S. drug companies are sourced from China and India. In 2017, Chinese drug manufactures received 22 warnings from the FDA compared to 5 warnings in 2014. European Medicines Agency data reported that 10 percent of the pharmaceutical raw materials made in China failed its inspection. In July, European Medicines Agency and the U. S. Food and Drug Administration issued warnings that antihypertensive drugs made in Zhejiang Province could cause cancer. In Beijing, the officials announced that hundreds and thousands of vaccines with quality issues were sold on the market and vaccine manufacturers were accused of forged production data. According to the FDA news website, in 2017, China joined the ICH (International Council for Harmonization) as its eighth regulatory member, pledging to transform its pharmaceutical regulatory authorities, industry, and research institutions gradually in order to implement the international coalition’s technical standards and guidelines.
Source: Central News Agency, August 7, 2018
http://www.cna.com.tw/news/acn/201808070293-1.aspx