The China Food and Drug Administration (CFDA) released the country’s first biosimilar guidelines on February 28, 2015. The final guidance, based on a draft released in November 2014, took into effect immediately.
Regarding the “hair” alike visible particles in Levofloxacin Hydrochloride and Sodium Chloride Injection produced by Shandong Qidu Pharmaceutical Co., Ltd., the local CFDA, Food and Drug Administration Zibo City, has measured out a severe punishment and ordered Shandong Qidu Pharmaceutical Co., Ltd. to suspend business for internal rectification, after the on-site inspection.
“Supervision and Control Rules for Food and Drug Management on the Internet” (hereinafter referred to as the “Rules”) medicine electricity traders eagerly awaited has been officially finalized. The Rules is expected to be announced shortly. Policy of prescription drugs online sales will soon be settled. The first batch of more than 200 products may be included. The e-commerce development of pharmaceutical industry will spurt.
Recently, the media reported that a clinic in Changchun city found a bottle of injection have the “hair” alike visible particles problem. Jilin Food and Drug Administration are carrying out in-depth investigation. China Food and Drug Administration (CFDA) paid high attention to the quality and safety issues, and sent investigation teams to Changchun and the drug manufacturer to verify the circumstances of product and patients. The investigation teams have conducted a comprehensive on-site inspection for the production enterprise of Shandong Qidu Pharmaceutical Co., Ltd.
The China Food and Drug Administration (CFDA) plans to allow online sales of prescription drugs as early as this month, opening up the market to existing online e-commerce platform operators like Alibaba.com and JD.com.
Speculation about a new policy has been circulating since mid-2014. If approved, the policy could lead to the emergence of a market worth more than RMB 1 trillion ($161 billion) as sales shift from hospitals to online pharmacies. The policy will also help reform the Chinese market that has been solely controlled by state hospitals and distributors.
Viagra’s patent in China has expired and some analysts expect cheaper prices will bring a surge of demand for the storied erectile dysfunction (ED) drug.
“China ED drugs market is an appealing cake with large profits,” said Dr. Neil Wang, China managing director at Frost & Sullivan, in emailed comments. “The launch of generic alternatives into the market will lead to intense competition.”
The size of the potential sales increase in China could be huge. Sales of ED drugs could triple to as much as 5 billion yuan ($810 million) by 2018 from an estimated 1.7 billion yuan in 2013, Citigroup estimated in a recent report.
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.
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.