December 12, 2016, Inside Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of ...

December 7, 2016, Covington Alert

In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the regime and uncertainty over its requirements.

November 2016, Insight Magazine

August 31, 2016, Inside Medical Devices

The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules).  This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which ...

March 25, 2016, Covington Alert

On March 23, 2016, Novartis AG (“Novartis”) agreed to pay $25 million to settle civil charges with the Securities and Exchange Commission (“SEC”) alleging that it violated the Foreign Corrupt Practices Act (the “FCPA”) by paying bribes to healthcare professionals (“HCPs”) in China from 2009 to 2013 to increase sales. Employees and managers of its two China-based subsidiaries attempted to hide the improper payments by using complicit third party agents and by improperly recording them as legitimate expenses for travel and entertainment, conferences, educational events, and medical studies. These books and records were later consolidated into the financial reports of Novartis, which is listed on the New York Stock Exchange. This conduct resulted in violations of the books and records and internal accounting controls provisions of the FCPA.

March 2016, Covington Alert

On March 1, 2016, the Securities and Exchange Commission announced an agreement with Qualcomm Incorporated to settle charges that it violated the Foreign Corrupt Practices Act by hiring relatives of Chinese government officials to gain business advantages in the Chinese telecommunications market. The SEC also alleged that Qualcomm provided gifts, travels, and entertainment -- including hospitality at sporting events such as the Olympics -- to Chinese officials and their family members to try to influence these officials to adopt and retain its technologies. According to the SEC, Qualcomm misrepresented these improper benefits in its books and records as legitimate business expenses. Qualcomm agreed to pay a civil money penalty of $7.5 million to the SEC without admitting or denying the SEC findings.

October 29, 2015, Covington Alert

2012, U.S. Chamber of Commerce