China

By 2020, the Chinese pharmaceutical market is projected to be valued at $120 billion, although the lack of R&D in the industry is currently holding back further growth and innovation. This is due largely in part to slow regulatory and review processes that can delay drug approvals for up to eight years. The China Food and Drug Administration (CFDA) has begun expediting drug development, with the agency reviewing 9,394 new drug applications in 2015, a 90% increase from the prior year. In late 2015, the State Council also announced new policies to accelerate the CFDA’s approval process, including prioritizing drugs developed for AIDS, tuberculosis, cancer and rare diseases; allowing outsourcing of drug manufacturing to CROs; and implementing a one-time approval process by the CFDA instead of the previous phase-by-phase approval model. The CFDA also aims to improve drug quality of preclinical and commercialized drugs, increase employment numbers at R&D agencies and apply biosimulation technologies to drug development to enhance approval rates. Biologics is projected to be a major area of growth.

Source: Contract Pharma

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