Hongqiao Forum holds parallel session on drug safety governance

The ongoing seventh Hongqiao International Economic Forum in Shanghai on Wednesday held a Parallel Session on Global Drug Safety Governance and Chinese Drug Regulation Innovation during which attendees exchanged views on the latest policies in Chinese pharmaceutical regulation and the internationalization of the pharmaceutical industry.

According to Zhao Junning, deputy director of China's National Medical Products Administration, in recent years, China has continuously deepened reform and innovation in drug regulatory policies, accelerated the review and approval process to meet urgent clinical needs, and established a scientific regulatory system covering the entire product lifecycle.

In 2023, the on-time completion rate for drug registration applications increased to 99.7 percent. Since the beginning of 2024, 91 drug registration applications have been included in the priority review and approval program, 69 applications in the breakthrough therapy program, and 17 applications have received conditional approval, Zhao said.

Meanwhile, China's National Medical Products Administration encouraged multinational enterprises to introduce advanced technologies into domestic production to promote the upgrading and development of the domestic pharmaceutical industry, he added.

"In international exchanges and cooperation, the National Medical Products Administration (NMPA) actively participates in global drug safety governance, fully engages in the development and implementation of international regulatory standards, aligns drug and medical device registration standards with global practices, and promotes the internationalization of China's pharmaceutical industry, continuously enhancing global recognition of Chinese innovative drugs," said Zhao.

Participants at the forum also shared their willingness to continue expanding the Chinese market and achieve cooperation, leveraging the momentum of the China International Import Expo (CIIE).

"China's made a lot of progress in strengthening the drug regulatory authorities. For example, taking some important policy innovations in recent years to speed up the time for registration of new drugs and to improve policy. This is important for the people in China so that they know that drugs and vaccines are safe and effective. But this is also important for people around the world. China is an increasing exporter of vaccines, of medicines, of active pharmaceutical ingredients. So China's regulatory strength is important, just not for China, but for around the world," said Martin Taylor, WHO Representative to China.

The Hongqiao International Economic Forum is held in tandem with the China International Import Expo (CIIE) , running from Tuesday till Sunday.

This year's CIIE has attracted participants from 152 countries, regions and international organizations. The overall exhibition area of the expo exceeds 420,000 square meters, with 297 of the global Fortune 500 enterprises and international industry leaders, and nearly 800 purchasing groups from different countries taking part, the number of which reached a new high.

Hongqiao Forum holds parallel session on drug safety governance

To meet the timeline of starting independent customs operations by the end of 2025, the government of south China's Hainan province issued a series of regulations to stipulate import and export management of Free Trade Port (FTP), with two major documents on environmental safety and medicine import put into effect recently.

To further explain the effects and scope of the two documents, the local government held press conferences on Monday and Tuesday.

The "Several Provisions on the Management of Entry Environmental Safety Access in the Hainan Free Trade Port" took effect on Wednesday, which clarified the scopes and responsibilities regarding potential environmental issues of vessels and import products.

"The document regulates the access management of special items such as hazardous waste, remanufactured products, carry-on items of entry personnel, and radioactive materials. Meanwhile, it clarifies that the storage sites for transit goods should meet environmental safety management requirements, to avoid environmental pollution," said Di Weijie, deputy director of the Department of Ecology and Environment of Hainan Province.

In addition, the administrative rule on zero-tariff import of medicines and medical devices in Hainan Free Trade Port was put into effect on Tuesday, stipulating that before Hainan FTP starts independent customs operations, medical institutions, higher medical education institutions, and pharmaceutical research institutes registered in the Hainan's Boao Lecheng Pilot Zone with independent legal status and approved eligibility can import designated pharmaceuticals and medical devices under the zero-tariff policy.

"The scope [of medicines and medical devices imported under 'zero-tariff' policy] consists of two categories: imported pharmaceuticals and medical devices already approved for registration in China, and specially licensed pharmaceuticals and medical devices for the Boao Lecheng Pilot Zone," said Jia Ning, director of Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, during the press conference.

With policy supports and related efforts like the Ever Lasting International Innovation Medicine Exhibition held in the Boao Lecheng Pilot Zone, medicine and health care is expected to be a new pillar industry for Hainan.

New regulations clarify environment, medicine import issues in Hainan Free Trade Port