Drugs from overseas to get on fast track

2017-07-14
China Daily

China will continue to intensify international exchanges and cooperation in drug supervision to promote the domestic application of new medicines developed overseas to meet demand, China’s top drug regulator said on July 13.

The drug authorities will also encourage the domestic pharmaceutical industry to improve its capacity and competitiveness to promote the international visibility of Chinese medical and pharmaceutical products, Wu Zhen, vice-minister of the China Food and Drug Administration, said at the opening ceremony of the BRICS Meeting on Drug Regulatory Collaboration in Zhengzhou, Henan province.

On June 19, the administration announced it joined the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, which focuses on guidelines for worldwide pharmaceutical development.

“Joining the council means the Chinese drug regulatory authorities, pharmaceutical industry and research and development institutes will gradually adopt internationally accepted standards and guidelines, actively participate in the formulation of international rules and promote quicker domestic application of new drugs developed in other countries,” Wu said.

China is the second-largest market for pharmaceutical products in the world. Annual revenues of the pharmaceutical industry in China exceed 2.5 trillion yuan ($368.6 billion), and annual exports of pharmaceutical products exceed 13.5 billion yuan, Wu said.

“China has great pharmaceutical production capacity, so it can provide support to the health of the people in BRICS nations and other countries,” he said.

BRICS comprises Brazil, Russia, India, China and South Africa.

The administration has adopted a series of reform measures on the review and approval of new drugs to accelerate approvals and meet the needs of domestic patients in recent years, Wu said.

The authorities will encourage medical institutions to give priority to new drugs that have proved effective and are reasonably priced, and support the inclusion of such new drugs in the list of drugs whose cost can be reimbursed by basic medical insurance programs, according to a draft regulation released by the administration in May.

Certain types of drugs and medical equipment already in use in other countries, such as those for curing rare diseases, can also gain priority approval for sale in the domestic market, the draft said.

As of the end of June, the administration had established routine work relations with drug regulatory authorities in 66 countries, and signed 42 agreements for bilateral cooperation with 28 countries and regions, said Yuan Lin, chief of the administration’s international cooperation department.