Earticle

Currently, local electromagnetic compatibility standards for medical equipment in Korea are not harmonized with international standards, which causes inconveniences to local manufacturers for their exports because the national standards the manufacturers apply for do not meet requirements of international standards. So these local standards in Korea are harmonized with international standards currently being used have been analysed.

Chlorhexidine gluconate is widely used for oral gargles, lens cleaners, feminie cleanser solutions, and antiseptics due to a strong antibacterial effect and low toxicity. The test method of chlorhexidine gluconate solution is listed in Korean Quasi-drug Codex(KQC), but it is difficult to apply to products with low concentration of chlorhexidine gluconate to be quantitatively analyzed. The purpose of this study is reviewing current analytical methods of chlorhexidine gluconate and establishing its internationally harmonized method. As a result, the test method of chlorhexidine gluconate would be reflected in the revision process of KQC and expected to provide the convenient method for quality control of quasi-drugs, cosmetics and drugs containing chlorhexidine gluconate.

New narcotics are appearing frequently all around the world, and health authorities are busy to cope with these. Because Korea has no specific article about drug designation in narcotic act, drug list of its enforcement ordinance should be amended whenever new narcotics appear. Such a procedure is time-consuming and ineffective. Some related statutes of other countries were investigated to improve this. An emergency procedure of USA and Germany which designates individual drugs temporarily omitting some procedure in urgent cases was introduced to our act on June, 2011. An analogue system of USA that a substance which has a substantially similar chemical structure with a controlled substance will be treated as a controlled substance is effective to cope with newly appearing derivatives, but the definition is too vague. The scope of each analogue is definite in New Zealand and UK, but the scientific background is not clear. For urgent improvement, some analogues were added to our drug list on February, 2011 based on Canadian analogue system.

In this study, We have proposed developed assay of ‘5% phytonadione’ in Korean Pharmaceutical Codex. Suggested test methods was developed by HPLC with ultraviolet detector. The assay was performed in an isocratic elution using a mobile phase composition of dehydrated ethanol and distilled water (95:5, v/v) and the analyte was monitored at 254 nm. The developed method was validated through linearity, range, system suitability, precision, accuracy, recovery and inter-laboratory variation according to the AGuideline on analytical procedures and method validation of pharmaceutical productsB(KFDA, 2008.12). The results of these study showed high specificity for 5% pytonadione. The coefficient of determination (R2) was 0.9998 and the recovery was 100.2%. Evaluation of precision was performed by comparative analysis of two equipments, and each equipment showed the relative standard deviations (RSD) 0.4% and 0.2%. The developed method was successfully applied to estimate the amount of phytonadione in 5% Phytonadione.

Codification of medical device safety information is essential in promotion of medical device safety information reporting and in systemization of reported information. This research aims to suggest code system of medical device safety information applicable to Korea. Literature review was conducted on the globally used code systems, including GHTF, ISO code system, MedDRA, US FDA code system. The assessment showed that US FDA code system is the most suitable system for Korea in consideration of its stratified structure and its applicability in data analysis. The conclusion was confirmed by experts in medical device industry. The principal institute organized consultation meetings and a workshop to request for opinions of industry leaders. In combination of literature review and experts' opinion, the principal institute finally concluded that US FDA code system is the most suitable. Additionally, US FDA code system was translated to develop a Korean version of code system, and suggestions for revising current medical devices regulations were developed to implementation of this code system in this study.

The aim of this study is to establish the limit of endotoxin on the pharmaceuticals. 16 items listed in the Korean Pharmacopoeia Codex were selected as sample and the endotoxin limit was calculated according to Decision of Limit for Bacterial Endotoxins, General Information of Korean Pharmacopoeia. And the contents of endotoxin in the samples were assayed according to Bacterial Endotoxin Test, the General Test, process and apparatus of Korean Pharmacopoeia and the experimental values were compared with calculated limits of endotoxin of the samples, and then final endotoxin limits of the samples were prepared.

In Korea, Government is actually determining the pricing of medicines. That is because most of the medicines are covered by National Insurance System and Government has the autority to fix the ceiling price covered by National Insurance System. It is rationalized on the fact that the medicines are significantly important in National health and Korea has a characterized National Insurance System. In this paper, the history of the pricing system in Korea is reviewed and lawsuit cases related to the pricing system are reviewed. The power of Government to determine the price of the medicines can be authorized, but the power should be used properly. I expect rational and proper answers to the problem of pricing is going to be suggested on and on.

Advances in communication networks including Internet have increased the usability of telemedicine and corresponding requirements. Since technologies associated with telemedicine have also gone through radical advances and changes, the chances for advanced telemedicine and its benefits are very high. On the other hand, the consideration of interoperability in domestically developed telemedicine systems necessitates systematic assessments of the performance, as well as the criteria for standard-based telemedicine systems, in a long-term strategic context. In this paper, we propose a set of performance evaluation criteria for telemedicine systems by using standards associated to health care.

Infant·childhood is the time to experience a big change physically and physiologically. Because there would be high possibility to cause a harmful influence in the long term if the exposure to hazards, it is required to manage the medical devices for an infant and a child strictly by preparing the standards to be applied the characteristics of an infant and a child. Among these medical electrical equipment, a Phototherapy unit is one of most important equipment to be used frequently in the hospitals in order to treat infant so that the standard for a Phototherapy unit is required to evaluate the safety and performance of the equipment. To develop the standard of a Phototherapy unit, the following international standards were examined; KS C 60601-2-50 a Phototherapy unit, IEC 60601-2-50(2000): a Phototherapy unit, EN 60601-2-50 (2000): a Phototherapy unit, KFDA guideline for a Phototherapy, the standards of manufacturers. In this study, through survery and inspection of international standards and guideline for a phototherapy unit, survery and inspection of international and domestic manufacturers' test items, proposals standards for the product by technical review, we suggest the standard for a Phototherapy Unit.

“Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity”, which was adopted on 2010 and will enter into force in 2014, requires the prior informed consent for access to genetic resources (including traditional knowledge) as well as the mutually agreed terms for the benefit-sharing from their utilization. Following this Protocol, the States rich in genetic resources will strengthen their biological sovereignty and ask the fair and equitable benefit-sharing, which will bring extra burden in the use of foreign biological resources. Because this Protocol not only includes genetic resources but also their derivatives for benefit-sharing, there will be the greatest impact on health industry producing natural herb drugs, functional foods and functional cosmetics. In this article, the preemptive actions against this Protocol in the field of food, drug and cosmetic industries was suggested. Since it is expected that Korea Food and Drug Administration will play roles as a Check Point as well as a National Focal Point in implementing Nagoya Protocol, it is recommended that a newly improved biological resources DB used in food, drug and cosmetic area should be constructed based on current “Herb Medicine” website in order to minimize the impact of Nagoya Protocol on domestic health industry, and that some laws, bylaws and guidelines in the field of health area should be further revised or amended in order to regulate the implementation of Nagoya Protocol in the field of food, drug and cosmetic industry.

Packaging process is a special process under the definition of GMP. That is, it shall be managed specially since the state of sterilization and product cannot be checked completely in the following inspection or test after packaging. The special management like this shall be started from the validation. Recently in case of the sterile product, the importance of packaging work process which maintains sterility and protects products together with the sterilization process is being highlighted. However, it is urgent to conduct a study on the guideline which can evaluate the safety and validity of packaging process since it is the actual situation in Korea not only that there is no guideline possible to evaluate the safety and validity of packaging process, but also that there is no practice case which is known widely. Therefore, we would like to develop the guideline which can be utilized at the site by reinterpreting current status on standards and studies in relation to the packaging at home and abroad through this study. Packaging validation may be referred to as the work checking the feasibility for the packed final product whether the process, facility or system functions properly as it was intended to with the objective evidence. This report would like to present practice cases such as various data analyses to perform the IQ (installation qualification), OQ (operation qualification), PQ (performance qualification) and packaging validation. The final objective of this research task is to build the guideline to packaging validation of medical devices which coincides with international standards and to reflect it to the screening and evaluation, etc. for the advancement in GMP operation of the medical device manufacturer. It is expected that the technological level of medical device manufacturer on GMP operation will be enhanced by preparing the guideline to packaging validation and practice standards through this study, and that it will contribute not only to the development of medical device industry, but also to the securement of health and safety of our people.

The biopharmaceutical drugs which are produced by recombinant DNA technology or new biotechnology and used for the treatment of human diseases have developed since 1980s, and successfully introduced in drug market. Some of them became blockbuster drugs and have entered in the category of major drugs having a grand market size. In this study, the registry of the biopharmaceutical drugs in official compendium including Korean Pharmacopoeia was investigated by comparing foreign pharmacopoeias such as US Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia. In Korea, biologic drugs have been regulated by the official notification[The Criteria and Test of Biologics\, and the recombinant pharmaceuticals has been also regulated in this notification. However, the market expansion of drugs in this category requires the official registry in the official compendium. In this article, the necessity of registration of some selected biopharmaceuticals in the official compendium is addressed, and the consideration points in general notices, general rules of preparations, general tests and general information of Korean Pharmacopoeia is suggested. In addition, the registration of biosimilar drugs in official compendium, for example in Korean Pharmaceutical Codex, is also proposed, for taking action on the market entrance of biosimilar drugs following the expiration of patent of oldest biopharmaceutical drugs. This will be helpful in more effective management and regulation of biopharmaceutical drugs and in harmonization with international requirements.