OBJECTIVES: In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the “Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)” were analyzed. METHODS: The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. RESULTS: Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. CONCLUSIONS: Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure- Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.
European Union ; Korea

OBJECTIVES: In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the “Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)” were analyzed. METHODS: The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. RESULTS: Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. CONCLUSIONS: Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure- Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.
European Union ; Korea

No abstract available.
Child* ; European Union* ; Humans

This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.
European Union ; Marketing ; United States

PURPOSE: To investigate the esophagographic findings of early esophageal cancer(EEC), and to compare thesewith the pathologic results, and to thus determine the most useful method of esophagography for the detection ofEEC. MATERIALS AND METHODS: We examined 18 patients(M : F = 16 : 2) with pathologically proven EEC ; 17 cases weresquamous cell carcinoma and one was adenocarcinoma. Tumor size, shape and location were evaluated byesophagography and the findings were compared with the pathologic results. RESULTS: The tumors were 0.5-7 cm insize ; all except two were smaller than 4cm. Twelve were located in the middle esophagus, five cases in the loweresophagus and one case in the upper esophagus ; in ten cases, the margin was ill-defined. Esophagography showedthat eight cases were of the superficial depressed type, seven were the superficial elevated type, and three werethe tumorous type. All 18 cases were detected by double contrast study, but mucosal relief study and bariumfilling study revealed only ten and eight cases, respectively ; for the detection of EEC, double contrast studywas thus the most useful. CONCLUSION: EEC was commonly demonstrated in the middle esophagus with an ill-definedmargin ; it was of the superficial depressed or elevated type. For the detection of EEC, double contrast study wasthe most useful.
Adenocarcinoma ; Esophageal Neoplasms* ; Esophagus ; European Union

The comprehensive European Board of Ophthalmology Diploma (EBOD) examination is one of 38 European medical specialty examinations. This review aims at disclosing the specific procedures and content of the EBOD examination. It is a descriptive study summarizing the present organization of the EBOD examination. It is the 3rd largest European postgraduate medical assessment after anaesthesiology and cardiology. The master language is English for the Part 1 written test (knowledge test with 52 modified type X multiple-choice questions) (in the past the written test was also available in French and German). Ophthalmology training of minimum 4 years in a full or associated European Union of Medical Specialists (UEMS) member state is a prerequisite. Problem-solving skills are tested in the Part 2 oral assessment, which is a viva of 4 subjects conducted in English with support for native language whenever feasible. The comprehensive EBOD examination is one of the leading examinations organized by UEMS European Boards or Specialist Sections from the point of number of examinees, item banking, and item contents.
Cardiology ; Disclosure ; Europe ; European Union ; Ophthalmology* ; Specialization

European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.
Device Approval ; European Union ; Product Surveillance, Postmarketing

During the seven-year transitional period of European Union Directive 2004/24/EC, only a few of traditional Chinese medicines had been approved for registration. In other words, the EU directive has become an unavoidable registration barrier to hinder Chinese enterprises from entering EU market. By analyzing difficulties of enterprises in registration in EU and studying the only successful case in China--Di Ao Group, this article proposes countermeasures in the hope of providing effective reference for Chinese enterprises in expanding EU market, and promoting the internationalization progress of traditional Chinese medicine.
European Union ; Humans ; Medicine, Chinese Traditional

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on
European Union ; Marketing ; Reagent Kits, Diagnostic

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.
European Union ; Industry ; Reagent Kits, Diagnostic