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1. Overview of Drug Administration in China
1.1 Regulatory Affairs Profile
China has established a quite streamlined drug regulatory system from nearly zero base during the last thirty years along with its national policy of reform and opening-up. SFDA and its affiliates play a key role in this system; they make decisions on approvals, additional requirements or exemptions. However, there are still many defects and loopholes in both process and regulations such as that provisions and guidelines are found vague or lack of explanations; and these flaws are part of the reason that regulation time takes longer than other countries. Knowing its deficiency, Chinese regulatory system is continuing evolving; it is trying to keep up with the standards of EU, USA and Japan.
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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.
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In late 2014, the China Food and Drug Administration (CFDA)’s Order No. 5 regarding administrative measures for the registration of in vitro diagnostic (IVD) reagents went into effect.
The new administrative measures brought about several changes to the regulation of IVDs. For example, certificate validation now lasts for 5 years rather than 4 years. In addition, country of origin requirements have been eased to accept approval in the country of the manufacturing site in addition to approval in the country of the legal manufacturer.
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