China to Allow Some Drugs & Medical Devices Based on Approval by Foreign Regulators

China will allow use of some drugs and medical devices based on approval by foreign regulators, the government said Monday, in a move that could help to ease access to its health care market.

The step was one of a series announced by Chinese drug regulators to improve access to treatments and streamline an approval process that foreign suppliers complain is too slow and complex.

The communist government is in the midst of a marathon effort to expand access to health care for China’s 1.4 billion people. At the same time, it faces pressure from trading partners to open its markets for medical technology.

Regulators want to improve access to “urgently needed drugs and medical devices,” the CFDA said in a statement.

“Regarding drugs and medical devices that already are approved to go on the market abroad, they will be allowed on the market with conditions attached,” the agency said.

The agency gave no details of what products might be affected or how the approval process would work.

Suppliers of drugs and devices such as X-ray machines have long looked at China as a promising market but complain that a cumbersome approval process that can take up to seven years hampers market access.

In 2015, the CFDA promised to simplify drug approvals and clear a backlog of applications.

Despite such steps, suppliers say Beijing is backtracking in some areas, such as by excluding foreign products from catalogs used by hospitals to purchase medical equipment.

Also Monday, the CFDA said it would streamline the process for approving generic drugs, a step that could undercut potential demand for foreign products.

Source: Associated Press