Pharmaceuticals in China: So long, easy money

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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Will generic Viagra transform China?

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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Details on China’s New Regulation for IVDs

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

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

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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CFDA issues Administrative Measures for Food and Drug Supervision Statistics

On December 19, 2014, China Food and Drug Administration (CFDA) issued the Administrative Measures for Food and Drug Supervision Statistics (CFDA Order No. 10). The Administrative Measures was adopted at the executive meeting of CFDA on September 29, 2014 and will come into force as of February 1, 2015.

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