China 2018 Drug Administration Annual Recapitulation
COVID-19 and China

In 2018, the frequency of published drug administration policies, rules, reforms and acts is most in all past years, so are the landing speed and the depth of the impact. Besides, the administrative organization structure changed - China Food and Drug Administration (CFDA) became history and what followed are three organizations: National Healthcare Security Administration (NHSA), National Health Commission and National Medical Products Administration (NMPA). The regulation of generic drugs entered a critical stage; oncological therapeutics were covered under national healthcare security; the new version of essential medicine catalog was published…… Along with the construction of national drug administration system, innovative acts and policies were installed, which have significantly impacted the entire drug industry.


China Food and Drug Administration announced public consultation about Drug Inspection Rules according to the Drug Administration Law and the Drug Administration Act. To normalize and regulate the process of drug inspection, CFDA drafted the Drug Inspection Rules to urge involved departments to build quality control system and take the responsibilities in drug inspection.


The Ministry of Industry and Information Technology of the PRC published the announcement of allying four departments to constructing production base for low mix and frequently-in-shortage drugs. The policy aimed at ensuring the supply of low mix and small production volume drugs in the market, which had been unstably provided due to pharma enterprises’ low incentive to produce. The base can integrate the market demand requests and swiftly respond, which guarantees the stable supply of various kinds of low mix and small production volume drugs.


CFDA published 2017 Drug Inspection Report, In the report, CFDA had authorized 394 drugs to be on market in China. The registration and application queue waiting to be reviewed had dropped to 4,000 cases comparing to the peak 22,000 cases in 2015.


The State Council of the PRC released a document aimed at promoting the research and availability of generic drugs and improving their quality and efficacy to lower healthcare costs and to better meet public demand.


CFDA published the announcement of reinforcing the scene inspection work in chemical generic injection drugs registration and application. While maintaining the rigorous review disciplines, the committee may request for scene inspection, especially for injection drug reviews.


NMPA published the announcement of drug follow-up inspection work of 2018. NMPA continued 2018’s random inspection and follow-up inspection works of 201 drug manufacturing enterprises to reinforce the drug administration.


NMPA announced the adjustments in drug clinical trial review process. The adjustment aimed at encouraging drug innovations and accelerating novel therapeutics, meeting the public medical need and clarifying the responsibilities of applicants.


In order to intensify the administration and ensure the quality of processed Chinese medicines, NMPA published the centralized management plan of processed Chinese medicines


Aiming at meeting the international criteria of application materials of the chemical generic drug long-term stability research, accelerating the progress of generic drug’s integrated reviews and encouraging new generic drug, NMPA published an announcement of new adjustments in chemical generic drug’s long-term stability research application materials’ requirements. In the announcement, submitted-for-review materials must include three registered samples’ 6-month long-term stability lab data.


NHSC issued the notification of adding 17 cancer drugs in the national basic medical insurance program. The expansion of drug coverage makes cancer drugs more affordable for cancer patients. The retail prices of the 17 drugs will fall by about 57 percent on average, and most of the imported drugs will be cheaper than neighboring countries and regions.


Intending to elevate drug quality and safety, NMPA published the guidelines of drug’s digital tracking system construction. The realization of “one drug one code, synchronized code and drug” is the direction of the construction. In order to speed up the process of drug information share and reinforce the administration of drug’s safety and quality, the drug information must be traceable from the origin to the end.


On December 28th, 2018, NMPA published the notification of the reviews of generic drug quality and effect’s consistency. NMPA will continuously release the exemptions or simplification the human-body-equivalent test variety catalogs and specific review requirements for exceptional cases. If enterprises encounter critical technical problems, they can reach drug review institutes for more information.

According to the Administration Center of China E-government Network published 2019 Pharmaceutical Industry Development Report, the pressure of drug price drop and the boosted production costs generated by new drug’s heavy investment will decrease pharmaceutical industry’s profitability, M&A will remain active and listed enterprises will compete for market share through investing more in R&D. With a preliminary estimate, the total profit of China’s pharmaceutical industry will reach USD 3.43 billion in year 2019, which is 6% YOY growth.


*Contributor: XU Tao

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