The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.
For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.
President Obama's trip to China was a productive one. Not to be overshadowed by the countries' new climate change accord is an agreement to expand the World Trade Organization's tariff-cutting Information Technology Agreement, to include a host of new products, including medical devices.
China's registration review process for imported medical devices and in vitro diagnostics has been shortened under new China FDA importation regulations that took effect last month, and companies that fail to follow the guidelines will not get a second chance, meaning any mistakes could prove fatal to a product's chances in China.
Bribery and pricing investigations aren't scaring Johnson & Johnson away from China. CEO Alex Gorsky tells The Wall Street Journal that his company is expanding full speed ahead in the fast-growing emerging market--and is actively looking at deals there to boost pharma sales.
Johnson & Johnson CEO Alex Gorsky likes to hint at trouble developing its Chinese sales, but don't expect him to come right out and criticize the prickly Chinese government. In an brief interview with The Wall Street Journal, Gorsky said J&J was looking for new acquisitions in China, with new drugs for lung cancer as one of its topic targets.
In a bit of a turnabout, Boehringer Ingelheim has landed a buyer from China for a U.S. plant it was closing even as it is building up its manufacturing operations in China.
Unfortunately for foreign devicemakers, import substitution appears to be one of the means by which China intends to achieve its goal of creating 10 med tech breadwinners worth 5 billion yuan ($820 million) apiece by 2020.
Multinational pharma companies have been targeting China for years with an eye on its aging population, expanding middle class and growing incidence of chronic maladies like diabetes. So how are Germany's leading pharmas, Bayer and Merck KGaA, carving out an edge for themselves? Reputation, tech-sharing and cold, hard cash.
J&J is officially cutting the ribbon on its new partnering office in Shanghai, completing the pharma giant's global plan to hit the ground running in all the world's top biotech hot spots. It's taking the wraps off of a lineup of new discovery deals with universities in the region. And it's spreading out feelers for more deals through satellite offices in Australia, Singapore and Japan.