On 31st Oct., the 2nd Boao International Conference on Real World Studies of 
Medical Products, held in Boao, Hainan, was attended by nearly 1,000 
participants from domestic and international pharmaceutical regulatory 
agencies, academic societies, industrial associations, pharmaceutical 
enterprises, etc. 

The conference featured a plenary session and eight sub-forums, and encompassed 
various fields related to international real-world research, and the scientific 
development of pharmaceutical product regulation. The topics covered real-world 
research, drug regulation, pharmaceutical instrument regulation, traditional 
Chinese medicine regulation, biostatistics, as well as economics. The 
conference provided a platform for exchanges and innovations of real-world data 
research and pharmaceutical product regulatory practices, offering new methods, 
standards and pathways for advancing the role of real-world research of 
pharmaceutical products in regulatory decision-making across China and the 
whole globe.

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

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

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

Source: Hainan Boao Lecheng International Medical Tourism Pilot Zone

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