KFDA Aims at Gaining Public
Confidence in
Safety of Foods, Medicines

Builds up a cooperative safety management community between civilian and gov't sectors

The commissioner of the Korea Food and Drug Administration said his office will make efforts to raise the public policy consensus rate by creating a transparent policymaking process and continuously expanding public participation in the process. "In order to enhance public trust, I will strive to establish a solid confidence foundation by sharing objective facts and information through expanded and diversified bilateral communication channels with both the public and our policy clients."The following are excerpts of a recent written interview with NewsWorld by Yun Yeo-pyo, commissioner of the Korea Food and Drug Administration (KFDA).
Question: About three months have passed since you took office. How has your job been during this short period?
Answer: I know well the fact that the KFDA has come under severe criticism and admonition rather than applause and encouragement despite its staff's undaunted efforts as the agency's work is at the center of public concern and social issues. In reality, however, the KFDA's public recognition as a full-fledged and core institution responsible for the safety of foods and drugs is high, but it still fails to gain enough confidence to meet the public's high demands.
In order to enhance public reliability, I will strive to establish a solid confidence foundation by sharing objective facts and information through expanded and diversified bilateral communication channels with both the public and our policy clients. I will make efforts to raise the public policy consensus rate by creating a transparent policymaking process and continuously expanding public participation in the process. I will push food and drug safety management policies designed to meet the public's expectations.
Q: Public concerns and expectations on the government's role in ensuring the safety of foods is mounting. What steps will be in place to ensure the safety of foods?
A: Of late, a series of accidents involving the discovery of alien matters has occurred, heightening public misgivings and distrust toward foods. I see high public expectations and concerns over the safety of foods. The KFDA implemented the measures announced on March 23 to increase public trust over public health and the safety of foods.
Among the major steps, first, it has worked out steps to help food makers take their cue in the control and management of alien matters, especially processes designed to cut down on the presence of alien matters and ways for distribution firms to handle, investigate and settle such incidents.
Secondly, it has built up a rapid mechanism designed to respond to customers'complaints in which food makers are required to report claims concerning alien matters to administrative authorities, including the KFDA, and customers are encouraged to participate in their voluntary management programs.
Thirdly, a swift retrieval mechanism has been activated. Businesses that are swift to recall the products in question on a voluntary basis will be given a more lenient administrative punishment. Additionally, a food record tracking system and a retrieval grading system have been introduced.
Fourthly, those who sell harmful foods intentionally and habitually will be dealt with through stern punishment measurements such as prison terms, class action lawsuits and a profit-retrieval system.
Fifthly, safety checks on imported foods will be reinforced by conducting random inspections of imported raw ingredients and on-site checks of the factories of exporting countries.
Sixthly, they call for the expansion of an advanced food safety management system where the Hazard Analysis Critical Control Points (HACCP) system is applied to small and medium enterprises (SMEs) on a gradual basis.
Our administration will do its utmost to make sure that people have no apprehensions about their foods by implementing the countermeasures without a hitch.
Q: What's the biggest issue in the pharmaceutical field's In this regard, what policies do you employ?
A: Since the inauguration of the new government, restriction reform and strengthened competitiveness have emerged as much talked-about topics of our society. The KFDA has been preparing measures to reform the restrictions and increase the competitive edge in the pharmaceutical sector since last year. On April 25, it announced a package of comprehensive measures to ensure the safe management of pharmaceuticals and explained it to the CEOs of pharmaceutical firms.
Speaking specifically, the package contains the top three urgent tasks the KFDA will carry out in the interests of the pharmaceutical industry to reform restrictions in such areas as permit examination and post-management jobs.
First of all, in order to solve the top three urgent tasks, a drug approval examination task force will be formed to execute a backlog of drug approvals and permits, including bioequivalent (BE) tests within a short period while relaxing procedural restrictions unrelated to safety management.
An approval system will be redesigned from the viewpoint of the clients in order to enhance the competitiveness of the industry while supporting corporate activities for the development of new products such as the flexible operation of systems for lessening the corporate burden and restriction reform for strategizing clinical tests.
Q: This year marks the 10 anniversary of the establishment of the KFDA. What priority policies is your agency pursuing?
A: Despite a short period of 10 years, the KFDA has established itself as a solid institution responsible for the protection of public health. However, new policy circumstances, characterized by uncertainties, convergence, diversification, excessive competition and knowledge informatization as well as complex and diverse policy demands have required new paradigms.
In order to realize the dual goals of expanding safe management nets of foods and pharmaceuticals and building up the infrastructure of the industry as the one with a virtuous circle, the KFDA strives to do its utmost to develop positive policies in the new perspective, focus on core capabilities based on practical policies and reestablish itself as a scientifically prestigious, reliable and honored institution by taking an attitude of serving the general public and offering services tailored to meet the customers'needs.
As part of efforts to evolve Korea into an advanced country that takes the lead in ensuring public health and enhancing national competitiveness, the agency plans to step up a preventive food management regime considering the public sentiment over the safety of foods. To this end, we will create a better environment for children's food, expand scientific and preventive management of harmful substances ranging from raw materials to finished products, step up preventive countermeasures against food poisoning and other safety accidents, and conduct organic and systematic controls over the production, customs clearance and distribution of imported foods.
Secondly, the KFDA will make efforts to ensure safety through leading the buildup of safety infrastructure and establish a competitive, virtuous structure for the health industry.
Thirdly, it will build up a safety management net tailored to meet the public's needs. The general public will be given scientific information on safety to offer them the right choice while safety standards through on-site consulting on safety will be enhanced and a solid quality management system designed to make people feel safe will be put in place.
Fourthly, it will strengthen the infrastructure on the safety of foods and medicines in order to cope with rising demand for safety management. We will establish such a foundation on safety and efficacy based on scientific reliability, such as an Oriental medicine quality certification system, work out an evaluation system on the safety of BINT (BT, IT and NT) convergence products such as nanotech-treated items and effectively cover areas vulnerable to safety management problems through the protection of the underprivileged.
Fifthly, we will encourage the civilian and government circles to collaborate in building up an effective joint safety management community.
Q: This year, the 10 anniversary of the establishment of the KFDA, is a significant year for the agency to make another leap forward. Will you comment on ways of developing the KFDA?
A: Our agency was established by taking its cue from the U.S. Food and Drug Administration, a globally recognized institution. As of 2007, the U.S. FDA has a budget 11 times greater than the KFDA along with 7.3 times as many employees. Despite the KFDA lagging behind advanced countries in terms of manpower and resources infrastructure, I bet on the conviction that our staff members are not less enthusiastic or capable than their counterparts in any other country in protecting and promoting public health through thorough safety management of foods and medicines.
However, policy environment and policy demands are complex and diverse, so a case involves a myriad of related-interest parties. In this context, the KFDA fails to effectively solve problems with a one-point system as it did in the past, but it is more desirable to rely on the multi-point system designed to ensure mutual management through the establishment of a joint civilian-government cooperative safety management community.
The KFDA's role in the joint civilian-government cooperative safety management community is to serve as a core manager in setting the direction of policies on the safety management of foods and medicines, coordinate and manage them. That is considered to be an approach suitable for a networking society to effectively solve social issues by mutually linking the government, the market and the civic society. The KFDA looks to boost the autonomy of the private sector by rationalizing restrictions for the purpose of the effective establishment and operation of the joint civilian-government cooperative safety management community, invigorate communication exchanges, institutionalize participation and delegate business areas in which the private sector has a competitive edge and expand cooperation among inter-agency and intra-agency organizations. nw

Yun Yeo-pyo, commissioner of the Korea Food and Drug Administration