China FDA plans to lift ban on online drug sales

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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.

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Pharmaceuticals in China: So long, easy money

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China is already the world’s third-biggest market, behind only America and Japan, and is likely to consume $75 billion-worth of medicines this year. Sales have been growing at a compound annual rate of nearly 25% since 2009. Rising incomes and rapid ageing mean that demand for drugs should continue soaring. The expansion of publicly funded health insurance should also, in theory, bolster demand.

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Overview of Chinese Regulatory Framework

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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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Will generic Viagra transform China?

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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.

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Importing Drugs Into China: An Update

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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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Details on China’s New Regulation for IVDs

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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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CFDA issues Administrative Measures for Food Safety Sampling and Testing

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In order to standardize food safety sampling and testing, enhance the supervision of food safety, promote administration by law and ensure the health and life safety of the public, the Administrative Measures for Food Safety Sampling and Testing was adopted at the executive meeting of China Food and Drug Administration (CFDA) on September 29, 2014.

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Chinese Drug Clinical Trials and Prices

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The Chinese government recently released new regulatory measures for clinical trials at medical institutions. The document lays out a strengthened code of conduct for hospitals and doctors conducting clinical trials. Companies that are carrying out clinical trials at Chinese hospitals should ensure that their policies and processes comply with the new laws.

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