Search results

After several years of drafting and three rounds of public consultation, the Ministry of Health has at last published the revised Good Supply Practice for Pharmaceutical Products (Revised GSP Standards) (药品经营质量管理规范) on 22 January 2013. The Revised GSP Standards...

Recent years have seen acquisitions become a common element of any growth strategy for multinationals engaged in China's pharmaceutical market.  At least half of the top 10 multinationals in China appear to be actively pursuing one or more targets with...

Corporations in the pharmaceutical industry face aggressive scrutiny of their business practices worldwide by government agencies and prosecutors. Standing out among the issues most relevant in this regard to industry players and financial investors is ‘off-label’...

On 1 August 2011, the State Food and Drug Administration (SFDA) issued a notice seeking public comments on the Amended Good Supply Practices for Pharmaceutical Products (Draft for Comments) (Draft GSP Standards) (in Chinese 药品经营质量管理规范(征求意见稿)). Below we set out...

On 17 January 2011, the Ministry of Health promulgated the Good Manufacturing Practice for Pharmaceutical Products (2010 version) (2010 GMP) , which raised the threshold for the first time since 1999 for drug manufacturers to qualify for Good Manufacturing Practice...

In general terms, the phrase 'off-label' when applied to the use of drugs refers to the application of a pharmaceutical product outside the scope of use approved by the applicable drug administration authorities.1 Off-label variances in that scope often...

To promote direct foreign investment and in line with the policy of the National Development and Reform Commission (NDRC), the Shanghai government issued an opinion in April to delegate further its verification and approval authority. The opinion is good news for...

China's Ministry of Commerce (MOFCOM) has outlined its plans for the development of the pharmaceutical sector from 2011 to 2015, focusing on the distribution of drugs. The outline expands on various themes relating to the consolidation of the pharmaceutical...

China is currently carrying out the most far-reaching reform of its healthcare services since the period of 'opening up' began in the 1980s. Most attention is usually given to the government's initiatives to expand medical insurance, the quality...

The pharmaceutical and biotech industries have a rich and creative history with strategic collaborative arrangements. The benefits of partnering are many, including sharing of risk throughout the product development cycle, obtaining capital infusions, and gaining...