PR100458

HAIKOU, China, Nov. 3, 2023 /Xinhua=KYODO JBN/--

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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