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E-mail China.org.cn, October 16, 2024
Poster News:
I noticed that the resolution adopted at the third plenary session of the 20th Central Committee of the Communist Party of China (CPC) has outlined plans to refine the food and drug safety responsibility system. Which aspects primarily touch upon the drug safety responsibility system? What specific ideas and measures does the medical products administration have in this regard? Thank you.
Li Li:
Thank you for your questions. I will address them. The implementation of responsibilities is the basis and premise for ensuring drug safety. It can be said that the reforms outlined by the third plenary session of the 20th CPC Central Committee regarding the refinement of the drug safety responsibility system capture the key to ensuring drug safety. This system involves a wide range of elements. We need to coordinate the implementation of supervisory responsibilities of government departments, the primary responsibilities of companies and the jurisdictional responsibilities of local Party committees and local governments, so that responsibilities are shared and efforts are united.
First, the drug regulatory authorities must fulfill their supervisory responsibilities. The supervision of drugs is a duty assigned to the drug regulatory authorities by law, and we are duty-bound. Drug regulatory authorities at all levels must strictly implement supervisory powers and enhance collaboration across regions and levels. The responsibilities and the imperative of fulfilling them must be communicated to specific officials in specific positions. We need to continuously improve the risk consultation mechanism for drug safety and help establish a regular and sustainable approach to identifying, assessing and addressing drug risks within key links, such as clinical trial management, contract drug manufacturing and online drug sales, as well as with key products like vaccines and drugs and medical devices chosen through centralized procurement, and also in key areas, such as rural and suburban areas. In the meantime, we need to strengthen collaboration with public security, health and healthcare security departments to improve systems, such as coordination between administrative law enforcement and criminal justice and joint disciplinary actions, and intensify law enforcement efforts to effectively deter illegal and criminal activities in the field of drug safety.
Second, pharmaceutical companies must fulfill their primary responsibilities. Drug safety depends not only on supervision, but also on production. As those who conduct drug research and development, production, and distribution, pharmaceutical companies hold primary responsibility for drug safety, so they must assume legal obligations for ensuring drug quality and safety. Drug regulatory authorities need to enforce effective supervision, provide more legal and cautionary education to companies, and encourage them to establish robust quality management systems tailored to their specific circumstances and products, so that every participant in the drug production and distribution chain meets their responsibilities, and drug quality and safety are ensured as a result.
Third, local Party committees and local governments must fulfill their jurisdictional responsibilities. General Secretary Xi Jinping has said that "it is a bounden responsibility for Party committees and governments at all levels to ensure drug safety. " According to the requirement for Party committees and governments to share these responsibilities, all localities should make it clear that Party committees and governments take overall responsibility for drug safety within their jurisdictions, with their primary leaders serving as the chief individual responsible for drug safety. Drug regulatory authorities will improve the mechanism for admonition regarding drug safety responsibilities. Localities will be encouraged to integrate drug safety into their economic and social development plans, to regularly assess and analyze their local drug safety conditions, to strengthen technical support capabilities for drug review, inspection, testing, etc., and to support supervisory authorities in fulfilling their legal responsibilities to ensure drug safety for their own regions.
At the same time, we should engage society more effectively in joint efforts for drug safety. Given that drug safety is crucial for people's health and lives, we must supervise drug safety for the people and with their support. We should actively develop teams to assist with supervision through collecting and communicating drug safety information as well as engaging in volunteer activities, and fully leverage the role of professionals, such as pharmaceutical company employees and licensed pharmacists. Through these efforts, we will promote public participation in joint efforts for drug safety. Thank you.
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