China ahead of Japan but behind US and EU in terms of review designations, finds GlobalData

China reformed its regulatory system in 2015 to include various fast-track programs to drive the development of drugs for unmet medical needs and serious conditions. This has allowed China to overtake Japan, but it still lags the US and EU markets in terms of the number of drugs designations awarded, reveals GlobalData, a leading data, and analytics company.

Reportedly, the introduction of review designations by China’s National Medical Products Administration (NMPA) in 2015 has shown some success, with over 190 drugs awarded a priority review, breakthrough therapy, or accelerated approval review designations.

Quentin Horgan, Senior Drugs Database Analyst, comments: “NMPA awarded review designations to 108% more drug candidates annually than Japan from 2017 to October 2021 despite Japan’s attempts to stimulate the development of drugs via its review designation scheme in 2017, named ‘Sakigake’ as part of the wider ‘Japan Revitalization Strategy’ intended to accelerate innovative pharmaceuticals’ path to market and to promote the involvement of foreign companies.”

However, China remains behind the EMA and the FDA in terms of the number of drugs awarded review designations. During the 2016-2021 period, the US awarded approximately nine times more designations and the EU awarded three times more designations than China.

Their leading position can be attributed to their head start, with the US implementing its review designation program with its first designation, the Orphan Drug designation in 1983, and the EU following suit in 2000.

Horgan concludes: “While Chinese review designations currently lag behind the US and the EU designation award numbers, it is likely that going into the future it will aim to increase the number of drugs awarded designations to match these industry leaders.”

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