News Feature | December 14, 2014

Foreign Drug Companies See Regulatory Delays In China

By Suzanne Hodsden

Changes in China’s regulatory procedure may mean delays of up to two years for many foreign pharmaceutical companies hoping to introduce new medicines to the Chinese market. The changes will affect over 33 new applications, Bloomberg reports.

The R&D-Based Pharmaceutical Association Committee (RDPAC) has raised concerns on what this could mean for pharma multi-nationals that are depending on a timely release of their products. The news has also spurred frustrations because the measures were released and put into immediate effect without any prior notice.

According to the RDPAC, drug makers typically have to wait two years to receive Chinese approvals to market new drugs, but now extensions in the process may have doubled the waiting period.

Before, the process was handled in two steps. First the company sought permission from China to conduct international clinical trials. Bloomberg notes that many companies conducted clinical trials in China specifically to speed this step. Second, the drug makers submitted their data for review and approval.

With the new changes, drug makers are now required to apply twice, once for clinical trial approval and a second time for permission to sell the drug in China.

In an RDPAC report published this week, the group cites McKinsey & Co., which estimates that the top 15 foreign multinationals that do business in China see an annual sales revenue of over $16 billion.

Joseph Cho, managing director of RDPAC, remarked, “Some of these investment plans are worth hundreds of millions of euros, and that’s why this has caused a big reaction from our member companies.”

One of the companies affected by the changes is German-based Bayer.

Joseph Scheeren, head global regulatory affairs for Bayer, told Bloomberg that Bayer has already been waiting for a year on regulatory approval for a new drug and now will have to wait even longer. He expressed his concerns over the affect this would have on the patent life of the products, which he did not name.

Lu Xianping, CEO of Chipscreen Biosciences, remarked that additional scrutiny could only benefit China and that some diseases might affect Asian patients differently.

“By adding a layer of approval, international multi-center clinical trials will be more carefully and rigorously examined,” he said.

Bloomberg noted that Chinese pharma companies would not be affected by the new changes.