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