Drugs’ Path to China Slows as Regulatory Delays Add Up, J&J Says

The Chinese pharmaceutical market is becoming increasingly challenging for drug companies because of how long regulators there take to approve new medicines, Johnson & Johnson’s Chief Scientific Officer Paul Stoffels said.

“It takes much longer now to get products approved,” Stoffels said in an interview Wednesday at the World Economic Forum in Davos, Switzerland. “If there’s anything slowing us down in China it’s much more that than the economic situation.”

It can take as long as seven years for J&J to introduce a new product in China, he said, and the process requires “much more investment.” J&J is the world’s biggest maker of health products, and is based in New Brunswick, New Jersey.

Foreign pharmaceutical companies in China have expressed concerns that regulations are slowing approvals. At least thirty-four applications from multinational drug companies have been or will be delayed after Chinese regulators began requiring an added administrative procedure before drugs can be approved, according to R&D-Based Pharmaceutical Association Committee, or RDPAC, an industry group.

Previously, Chinese approval for drugs developed through international trials took about two years, and may now take twice as long, according to RDPAC.

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