• Journal of the Society of Cosmetic Scientists of Korea
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• v.23 no.1
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• pp.5-20
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• 1997

War and poverty depress the consumption of cosmetics, while peace and prosperity encourage their proliferation. With the end of World War II, the US, Europe and Japan witnessed rapid growth of their cosmetic industries. The ending of the Cold War has stimulated the growth of the industry in Eastern Europe. Improved economies, and mass communication are also responsible for the fast growth of the cosmetic industries in many Asian nations. The rapid development of the cosmetic industry in mainland China over the past decade proves that changing economies and political climates can deeply affect the health of our business. In addition to war, economy, political climate and mass communication, factors such as lifestyle, religion, morality and value concepts, can also affect the growth of our industry. Cosmetics are the product of the society. As society and the needs of its people change, cosmetics also evolve with respect to their contents, packaging, distribution, marketing concepts, and emphasis. In many ways, cosmetics mirror our society, reflecting social changes. Until the early 70's, cosmetics in the US were primarily developed for white women. The civil rights movement of the 60's gave birth to ethnic cosmetics, and products designed for African-Americans became popular in the 70's and 80's. The consumerism of the 70's led the FDA to tighten cosmetic regulations, forcing manufacturers to disclose ingredients on their labels. The result was the spread of safety-oriented, "hypoallergenic" cosmetics and more selective use of ingredients. The new ingredient labeling law in Europe is also likely to affect the manner in which development chemists choose ingredients for new products. Environmental pollution, too, can affect cosmetics trends. For example, the concern over ozone depletion in the stratosphere has promoted the consumption of suncare products. Similarly, the popularity of natural cosmetic ingredients, the search of non-animal testing methods, and ecology-conscious cosmetic packaging seen in recent years all reflect the profound influences of our changing world. In the 1980's, a class of efficacy-oriented skin-care products, which the New York Times dubbed "serious" cosmetics, emerged in the US. "Cosmeceuticals" refer to hybrids of cosmetics and pharmaceuticals which have gained importance in the US in the 90's and are quickly spreading world-wide. In spite of regulatory problems, consumer demand and new technologies continue to encourage their development. New classes of cosmeceuticals are emerging to meet the demands of increasingly affluent Asian consumers as we enter the 21st century. as we enter the 21st century.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• Journal of Acupuncture Research
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• v.32 no.4
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• pp.91-102
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• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• The Korean Journal of Applied Statistics
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• v.23 no.1
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• pp.139-150
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• 2010

In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on $2\;{\times}\;4$ crossover design, while a $2\;{\times}\;3$ crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under $3\;{\times}\;2$ crossover designs is proposed and some statistical points are discussed with $2\;{\times}\;3$ crossover design and $2\;{\times}\;3$ extra-reference design through simulation studies.

• Journal of the korean academy of Pediatric Dentistry
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• v.47 no.2
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• pp.228-234
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• 2020

Chloral hydrate (CH) has been used in sedation for over 100 years. CH was first synthesized in 1832, the sedative properties were observed in 1861. Because of its easy synthesis, its use was widespread since 1869. There is a record of the use of CH in children as early as 1894. Recently there have been many controversies about safety of CH. Because of the low cost and relatively safe experience CH has still been used for dental sedation in children. After the US FDA recommendation in 2006, US pharmaceutical companies no longer produce commercial CH. However, CH has been used in the form of suspensions prepared from raw materials in many areas of the United States, and reports of adverse events related to death have continued. CH is the most commonly used drug for sedation in Korea, and there have been some reports of side effects. Dexmedetomidine, propofol and midazolam were introduced as an alternative for CH. There are various limitations in using them in the pediatric dentistry area and there are many things to consider. The purpose of this review is to analyze the complications of CH and status of use in Korea, and to introduce alternatives to CH.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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• pp.471-481
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• 2005

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

• Korea Trade Review
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• v.44 no.2
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• pp.109-126
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• 2019

Import refusals can be considered a new method of non-tariff barriers. This study aims to analyze reputation spillover effects on fish and fishery products imported from ASEAN countries to the U.S. FDA. The supply of aquatic products is not stable due to various factors such as reduction of fish stocks and climate change. Fish is a basic food ingested directly, but there are many ways to control the safety of aquatic products. ASEAN countries account for about 20% of U.S.imports in fish and fishery products. For Southeast Asian countries, fish and fishery products comprise a high proportion of exports revenue. Despite the large share of exports to the U.S., Southeast Asia countries have been receiving many import refusals from the United States. In this study, a theoretical model for examining import refusals is suggested using the negative binomial counting process. The reputation spillover effect, was divided into two spillover effects of 'neighbor reputation' and 'sector reputation'. Results show that there exists a neighbor reputation spillover effect. It can be said if there was a import refusal of the same product from neighboring countries in the preceding year, the home country have a possibility to experience import refusals of the same product. Therefore, it is interpreted that neighboring countries have good standard compliance can help home countries to effectively reach the target markets. Our findings have a important policy implication for ASEAN exporters of fish and fishery products.

• Journal of Pharmaceutical Investigation
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• v.35 no.1
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• pp.57-63
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• 2005

Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.

• YAKHAK HOEJI
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• v.59 no.1
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• pp.40-46
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• 2015

The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

• Journal of Dental Rehabilitation and Applied Science
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• v.30 no.3
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• pp.231-237
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• 2014

Botulinum toxin has been used for treating chronic migraine under US Food and Drug Administration approval since 2010. However there is no definitive guideline for injection point. The aim of this study is to propose an effective and safe injection guideline by reviewing the previous studies.