• Proceedings of the PSK Conference
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• 2003.10a
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• pp.35-37
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• 2003

Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)

• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• Natural Product Sciences
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• v.10 no.6
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• pp.310-314
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• 2004

This is the re-arrangement of the 2004 Asia Nutrition & Dietary Supplement Conference organized by ABF(The Asia Business Forum) in Singapore, especially regulatory view of point of health functional foods for Korea, Japan, and China. Foods that may have health benefits beyond the traditional nutrients that they contain are often called 'Functional Foods'. The concept of functional foods has become popular in recent years, first in Japan and later in other countries, including the USA. In USA, The functional foods was controlled by ACSH (the American Council on Science and Health). In Korea, 'Functional Foods'. was defined on the 'The Law for the Health Functional Foods'(Law No. 6727 : effective as of $26^{th}$, Aug. 2002). KFDA(Korea Food and Drug Administration) is the only authority body for approval, advertisement and claims for the Health Functional Foods in Korea. In Japan, the Japan Health Food and Nutrition Food Association controls the approval, regulate functional foods' advertisement and claims under the name of FOSHU (Foods for Specified Health Uses). In China, the State Food and Drug Administration(SFDA) is the only authoritative organization for the application, supervision and administration of health related products. Asia, especially Korea, Japan and China, is one of the leader in the vitamins and dietary supplement(VDS) market. Regulatory issues on restrictions are the most important how to tap into the health functional foods market including Korea.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Journal of Society of Preventive Korean Medicine
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• v.18 no.1
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• Archives of Pharmacal Research
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• v.21 no.2
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• pp.89-105
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• 1998

In the past decade, significant progress has been achieved in the battle against hepatitis B virus. In addition to the immunomodulating agents such as interferon-.alpha., and thymosin, many novel antiviral agents have been discovered, among which nucleoside analogues are the mainstay. New-generation compounds such as 3TC and famciclovir have shown promise in the treatment of patients chronically infected by this virus, and are on the line for approval. However, viral rebound after cessation of therapy still remains a major problem. Additionally, the reports on the drug resistance to these antiviral agents suggest that combination therapy will be the eventual strategy (Bartholomew et al., 1997; Tipples et al., 1996). Therefore, developments of safe and effective antiviral agents which do not cross-resist with currently available antiviral drugs are still much needed.

• Health Policy and Management
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• v.16 no.4
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• pp.147-168
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• 2006

Technological innovation has been regarded as the core competence for the economic growth of individual, as well as organization and country. Pharmaceutical innovation, what we call new medicines, influence people's longevity and productivity by increasing output per hour worked. Therefore, using claims data on virtually all the drugs and diseases of over 550,000 people enrolled in National Health Insurance Program in Korea, we examined the impact of the vintage (original FDA and KFDA approval year) of drugs used to treat a patients from July 1st to December 31st in 2002 on the patient's mortality at the end of 2004, controlling for demographic characteristics(age and sex), utilization of medical services, and the nature and complexity of illness. We found that people using newer drugs are less likely to die at the end of 2004, conditional on covariates. The estimated mortality rates were declining with respect to drug vintage for 1970s, 1980s and 1990s and highly significant. In addition to estimating the model for the entire sample, we estimated the model separately for several disease categories classified by Korean Classification of Disease. Estimates of three drug vintage variables for subgroups of people with (1)neoplasms, (2)endocrine, nutritional and metabolic diseases, and (3)the diseases of circulatory system displayed similar patterns.

• YAKHAK HOEJI
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• v.52 no.2
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• pp.151-159
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• 2008

Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

• The Korean Journal of Nuclear Medicine
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• v.38 no.2
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• pp.140-142
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• 2004

As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. for clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.

• Journal of Korean Medical classics
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• v.27 no.4
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.