The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

HAIKOU,China,Nov. 3,2023 -- On 31st Oct.,the 2nd Boao International Conference on Real World Studies ofMedical Products,held in Boao,Hainan,was attended by nearly 1,000participants from domestic and international pharmaceutical regulatoryagencies,academic societies,industrial associations,pharmaceuticalenterprises,etc.

The 2nd Boao International Conference on Real World Studies of Medical Products

The conference featured a plenary session and eight sub-forums,and encompassedvarious fields related to international real-world research,and the scientificdevelopment of pharmaceutical product regulation. The topics covered real-worldresearch,drug regulation,pharmaceutical instrument regulation,traditionalChinese medicine regulation,biostatistics,as well as economics. Theconference provided a platform for exchanges and innovations of real-world dataresearch and pharmaceutical product regulatory practices,offering new methods,standards and pathways for advancing the role of real-world research ofpharmaceutical products in regulatory decision-making across China and thewhole globe.

It's worth noting that the National Medical Products Administration and the Hainan provincial government jointly initiated a pilot project for theapplication of clinical real-world data in June 2019. In the meantime,theHainan Boao Lecheng International Medical Tourism Pilot Zone (Lecheng PilotZone) has been actively collecting real-world evidences and researching toexplore how to assist the regulatory decision-making,offering new methods forthe reform of the national evaluation system of pharmaceutical products.Nowadays,the real-world research in the Lecheng Pilot Zone has stepped on afast track,largely matching the international advanced level in pharmaceuticaltechnology,instrument and drugs. It has become a key channel to accelerate themarket entry of innovative international pharmaceutical products to China.

According to Deputy Director of Biostatistics and Epidemiology,Real WorldEvidence Department,Merck,Germany,Real world study is a significantinstitutional innovation in the Hainan Free Trade Port. "We learnt that fourdrugs and nine medical devices have been approved by National Medical ProductsAdministration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng. Welook forward to seeing more advances made in this field in China."

To date,the Lecheng Pilot Zone has 26 operational medical institutions and hasestablished extensive and deep collaborations with over 170 pharmaceuticalproduct enterprises from 20 countries and regions,importing more than 350critically-needed pharmaceutical products.

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