Simplified Chinese
The National Medical Products Administration has outlined its key priorities for 2019: advancing the improvement of the vaccine regulatory system.
Release date:
2019-02-28
Author:
Source:
China News Service
Abstract
According to the website of the State Administration for Market Regulation, nationwide pharmaceutical supervision and management work… Meeting The meeting was convened. At the conference, Jiao Hong, Director of the National Medical Products Administration, stated that in 2019, efforts would be made to further improve the vaccine regulatory system and firmly safeguard the safety baseline. Responsibilities for vaccine regulation will be strictly enforced, oversight and inspections will be strengthened, testing and inspection of vaccine batches will be intensified, and cases will be placed under special supervision and follow-up.
At the meeting, Jiao Hong outlined six key priorities for 2019: first, to improve the regulatory and standards framework and ensure the implementation of the “four strictest” requirements. This includes actively advancing the formulation, revision, and enforcement of laws and regulations, as well as accelerating the development of a robust standards system.
Second, we will deepen reform of the review and approval system to promote high-quality development of the pharmaceutical industry. We will accelerate the market launch of new drugs, make every effort to advance the evaluation of generic drug quality and therapeutic equivalence, and further push forward… Medical device Reform the review and approval system and improve the registration and filing management of cosmetics.
Third, we will advance the improvement of the vaccine regulatory system and firmly safeguard the safety baseline. We will strictly enforce vaccine regulatory responsibilities, strengthen oversight and inspection, intensify batch-release testing and inspections, and implement a case‑by‑case supervision and accountability mechanism.
Fourth, we will uphold the risk-management philosophy and rigorously prevent and control risks. We will strengthen oversight of high-risk priority products and enhance random inspections and monitoring, while severely cracking down on illegal and non-compliant activities.
Fifth, advance regulatory science research and enhance the modernization of regulatory practices.
Sixth, we will vigorously advance smart regulation and continuously innovate regulatory approaches and methods.
At the meeting, Jiao Hong also put forward three requirements: first, strengthen regulatory capacity, ensure that regulatory responsibilities are fulfilled, hold enterprises fully accountable for their own responsibilities, and reinforce local governments’ management accountability.
Second, we will strengthen capacity building, consolidate the regulatory foundation, refine the quality management system of regulatory authorities, establish and improve a pharmaceutical emergency management mechanism, and enhance the overall competence of regulatory operations.
Third, we will strengthen our service orientation and enhance regulatory effectiveness, putting our commitment to service into practice through concrete actions and building a new image of drug regulation characterized by integrity.
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