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Overseas checks of drugs to increase

Wang Xiaodong and Wang Xiaoyu
Updated: Jul 13,2018 9:02 AM     China Daily

China will intensify its inspections at the overseas production sites of drugs and medical equipment intended for export to China to ensure safety, the State Drug Administration, China’s top drug regulator, said on July 12.

Last year, Chinese drug inspectors conducted on-site inspections of 48 overseas pharmaceutical companies — more than six times the number conducted in 2016 — according to the administration’s Center for Food and Drug Inspection.

Inspectors also conducted overseas site inspections on 24 manufacturers of medical equipment, an increase of 26 percent from 2016, the center said.

One of the drugs to be covered this year is a vaccine that works against as many as nine types of HPV, a major cause of cervical cancer and one of the most common cancers among Chinese women, the center said.

The vaccine, developed by US company MSD, was approved by the administration in April.

But the center declined to give details about overseas site inspections planned for this year.

In 2016, overseas on-site inspections covered seven drugs, three of which failed inspections due to problems in quality control, management and reliability of data, the center said.

The regulator responded by suspending imports, ordering producers to rectify the problems and suspending approval procedures, the center said.

“Such on-site inspections have eliminated safety risks for imported drugs at the border, and propelled overseas drug and medical equipment producers to do more to follow Chinese laws and regulations,” it said.

However, lack of experience and personnel mean that China still faces many challenges in conducting effective site inspections overseas, it said.

The center started inspecting in 2011, but as of the end of last year only 107 inspectors had gone to overseas production sites, far short of what is needed, it said. The number of inspections overseas is far below the number conducted in China by developed countries, it said.

The center plans to do more, including training more inspectors.

Over the past several years, China has accelerated the assessment procedure for new drugs made overseas to meet demand from domestic patients.

Authorities have accepted the validity of data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment, following a guideline released by the central government in October.

The measure is expected to greatly expedite the use of new drugs in China and reduce delays. Previously, drug authorities in China did not accept clinical trial data collected outside the country, so overseas pharmaceutical producers had to go through lengthy approval procedures again in China even if their products were already in wide use abroad.