CHINA BRIEFING January 2012 (February 13, 2012) - Pharmaceuticals, Devices, Health Care & Life Sciences


In This Issue: Regulations & News

Excerpt from Regulations

Notice from the Ministry of Health concerning the Outline of China’s Nursing Development Plan from 2011 to 2015 – January 9, 2012

On December 31, 2011, the Ministry of Health issued the Outline of China’s Nursing Development Plan (2011 – 2015), which clarifies the goals in developing nursing services during the 11th five-year period. The Outline presents the guiding ideologies and principles, main goals and key tasks of development, major development projects, and safeguard measures from 2011 to 2015. By 2015, the number of registered nurses should reach 2.86 million, of which 300,000 will be located in primary medical institutions. In addition, China will select 10 cities for a longterm nursing services pilot program.

Promulgation of Eight Recommended Medical Product Industry Standards –January 9, 2012

On December 14, 2011, the Ministry of Health (MOH) released an announcement to establish eight medical product industry standards that include:

• Enzymatic determination of serum triglycerides
• Interoperability matrix effects and evaluation guidelines
• Clinical application guidelines of markers of bone metabolism
• Immunoassay of serum (plasma) lipoprotein (a)
• Collection and handling guidelines of blood specimen for coagulase tests
• Guidelines for flow cytometry in peripheral blood lymphocyte subsets
• Reference methods of determination of catalytic activity concentrations of lactate dehydrogenase
• Spectrophotometry of serum cholesterol reference measurement procedures

The new standards will come into force June 1, 2012.

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