Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea

2020 ◽  
Vol 7 (1) ◽  
pp. 71-81
Author(s):  
Kunta N. Reddy ◽  
Surenahalli G. Vasantharaju
Keyword(s):  
South Korea ◽  
Emerging Markets ◽  
Regulatory Authority ◽  
Pharmaceutical Manufacturer ◽  
Regulatory Requirements ◽  
Confidential Information ◽  
Master File ◽  
Regulatory Perspective ◽  
Similarities And Differences ◽  
And Control

Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market. Methods: The method carried out for every single study follows some patterns and certain pathways in order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities, Legislations, Guidelines and Experts opinion. Results: Regulatory requirements for filing a DMF for API registration vary from country to country. Even though a standard ICH-CTD format is available and most widely followed, there are some specific requirements recommended by drug authorities which are mandatory to be provided while filing to that particular country. Conclusion: Based on the current study it is clear that emerging markets possess more stringent requirements for API approval as compared to the regulatory market but the dispute is that the emerging markets do not have harmonized guidelines and are not transparent enough.

scholarly journals ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES

2013 ◽  
Vol 1 (4) ◽  
pp. 1-11
Author(s):  
Achin Jain ◽  
M P Venkatesh ◽  
Pramod T.M. Kumar
Keyword(s):  
Developing Countries ◽  
Regulatory Authority ◽  
Drug Product ◽  
Low Cost ◽  
East Asian ◽  
Developed Countries ◽  
Technical Document ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Similarities And Differences

Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping countries which makes the approval process tedious and time consuming for the later. To make thisprocess smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN)nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences,hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between boththe guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTDand highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations ofdeveloped countries.

scholarly journals Engineering care in pandemic technogovernance: The politics of care in China and South Korea’s COVID-19 tracking apps

2021 ◽  
pp. 146144482110207
Author(s):  
Youngrim Kim ◽  
Yuchen Chen ◽  
Fan Liang
Keyword(s):  
South Korea ◽  
Textual Analysis ◽  
National Belonging ◽  
Surveillance Studies ◽  
South Korean ◽  
Care Services ◽  
Ideological Dimension ◽  
And Control

This article critically examines South Korea and China’s COVID-19 tracking apps by bridging surveillance studies with feminist technoscience’s understanding of the “politics of care”. Conducting critical readings of the apps and textual analysis of discursive materials, we demonstrate how the ideological, relational, and material practices of the apps strategically deployed “care” to normalize a particular form of pandemic technogovernance in these two countries. In the ideological dimension, media and state discourse utilized a combination of vilifying and nationalist rhetoric that framed one’s acquiescence to surveillance as a demonstration of national belonging. Meanwhile, the apps also performed ambivalent roles in facilitating essential care services and mobilizing self-tracking activities, which contributed to the manufacturing of pseudonormality in these societies. In the end, we argue that the Chinese and South Korean governments managed to frame their aggressive surveillance infrastructure during COVID-19 as a form of paternalistic care by finessing the blurred boundaries between care and control.

scholarly journals Highly Pathogenic Avian Influenza Clade 2.3.4.4b Subtype H5N8 Virus Isolated from Mandarin Duck in South Korea, 2020

Viruses ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1389 ◽  
Author(s):  
Sol Jeong ◽  
Dong-Hun Lee ◽  
Jung-Hoon Kwon ◽  
Yu-Jin Kim ◽  
Sun-Hak Lee ◽  
...  
Keyword(s):  
Phylogenetic Analysis ◽  
Avian Influenza ◽  
South Korea ◽  
Highly Pathogenic Avian Influenza ◽  
Control Strategies ◽  
Highly Pathogenic ◽  
Pathogenic Avian Influenza ◽  
H5n8 Virus ◽  
And Control ◽  
Comparative Phylogenetic Analysis

In October 2020, a highly pathogenic avian influenza (HPAI) subtype H5N8 virus was identified from a fecal sample of a wild mandarin duck (Aix galericulata) in South Korea. We sequenced all eight genome segments of the virus, designated as A/Mandarin duck/Korea/K20-551-4/2020(H5N8), and conducted genetic characterization and comparative phylogenetic analysis to track its origin. Genome sequencing and phylogenetic analysis show that the hemagglutinin gene belongs to H5 clade 2.3.4.4 subgroup B. All genes share high levels of nucleotide identity with H5N8 HPAI viruses identified from Europe during early 2020. Enhanced active surveillance in wild and domestic birds is needed to monitor the introduction and spread of HPAI via wild birds and to inform the design of improved prevention and control strategies.

scholarly journals COVID-19 in South Korea: Proper timing for Easing Mask mandates after COVID-19 Vaccination

2021 ◽  
pp. 1-9
Author(s):  
Yun-Jung Kang
Keyword(s):  
South Korea ◽  
Disease Control ◽  
Prevention And Control ◽  
Control Measures ◽  
Social Distancing ◽  
Proper Timing ◽  
Control And Prevention ◽  
Prevention And Control Measures ◽  
And Control

Abstract As of 25 July 2021, the Korea Disease Control and Prevention Agency reported 1,422 new COVID-19 cases, 188,848 total cases, and 2.073 total deaths (1.10% fatality rates). Since the first SARS-CoV-2 case was reported, efforts to find a treatment and vaccine against COVID-19 have been widespread. Four vaccines are on the WHO’s emergency use listing and are approved of their usage; BNT162b2, mRNA-1273, AZD1222, and Ad26.COV2.S. Vaccines against SARS-CoV-2 need at least 14 days to achieve effectiveness. Thus, people should abide by prevention and control measures, including wearing masks, washing hands, and social distancing. However, a lot of new cases were reported after vaccinations, as many people did not follow the prevention control measures before the end of the 14 days period. There is no doubt we need to break free from mask mandates. But let us not decide the timing in haste. Even if the mask mandates are eased, they should be changed depending on the number of reported cases, vaccinations, as well as prevention and control measures on how circumstances are changing under the influence of mutant coronavirus.

scholarly journals Genetic and Pathogenic Characterization of QX(GI-19)-Recombinant Infectious Bronchitis Viruses in South Korea

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1163
Author(s):  
So-Youn Youn ◽  
Ji-Youn Lee ◽  
You-Chan Bae ◽  
Yong-Kuk Kwon ◽  
Hye-Ryoung Kim
Keyword(s):  
Phylogenetic Analysis ◽  
Disease Prevention ◽  
South Korea ◽  
Prevention And Control ◽  
Genetic Recombination ◽  
Detection Methods ◽  
Infectious Bronchitis ◽  
Reference Sequences ◽  
And Control

Infectious bronchitis viruses (IBVs) are evolving continuously via genetic drift and genetic recombination, making disease prevention and control difficult. In this study, we undertook genetic and pathogenic characterization of recombinant IBVs isolated from chickens in South Korea between 2003 and 2019. Phylogenetic analysis showed that 46 IBV isolates belonged to GI-19, which includes nephropathogenic IBVs. Ten isolates formed a new cluster, the genomic sequences of which were different from those of reference sequences. Recombination events in the S1 gene were identified, with putative parental strains identified as QX-like, KM91-like, and GI-15. Recombination detection methods identified three patterns (rGI-19-I, rGI-19-II, and rGI-19-III). To better understand the pathogenicity of recombinant IBVs, we compared the pathogenicity of GI-19 with that of the rGI-19s. The results suggest that rGI-19s may be more likely to cause trachea infections than GI-19, whereas rGI-19s were less pathogenic in the kidney. Additionally, the pathogenicity of rGI-19s varied according to the genotype of the major parent. These results indicate that genetic recombination between heterologous strains belonging to different genotypes has occurred, resulting in the emergence of new recombinant IBVs in South Korea.

Semiosis between Action and Passion

2014 ◽  
Vol 10 (4) ◽  
Author(s):  
Eliseo Fernández
Keyword(s):  
Biological Evolution ◽  
Cell Physiology ◽  
Concomitant Increase ◽  
Afferent Pathways ◽  
Surrounding Environment ◽  
Directed Action ◽  
Similarities And Differences ◽  
And Control ◽  
Self Organizing

AbstractAll organisms are autonomous, self-organizing wholes separated by semi-permeable boundaries from a surrounding environment. Across these boundaries conveyances of action and passion are channeled through efferent and afferent pathways. I analyze this scheme in terms of two fundamental processes: semiosis and control. I propose a unified account of the functioning of semiosis and of controlling and controlled actions by viewing organisms as systems that separate their responses (actions) from the actions their environment exerts upon them (passions). Semiosis and goal-directed action are seen as complementary forms of causation. Examples from cell physiology and the functioning of efferent and afferent pathways in plants and animals illustrate and expand these ideas.Based on this interpretation of the relations between semiosis and control I reach a generalized conception of purposeful action, linking the expansion of semiotic capacities throughout biological evolution to a concomitant increase in an organism’s powers for intervention in its environment.The fruitfulness of these ideas is substantiated through examples showing how they make intelligible phenomena previously deemed disparate. Examples include similarities and differences between signs and instruments, and analogies in the evolution of organisms and artifacts.

Foreword / Uvodnik

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Tomislav Topolovčan
Keyword(s):  
South Korea ◽  
Bosnia And Herzegovina ◽  
Original Research ◽  
Research Papers ◽  
High Quality ◽  
Great Pleasure ◽  
Research Results ◽  
Scientific Explanations ◽  
And Control

Dear readers!It is our great pleasure to present to you the first regular issue of the Croatian Journal of Education in 2021. This issue brings ten papers by authors from Bosnia and Herzegovina, Croatia, South Korea, Serbia, Spain and Turkey. Regarding the categorisation of the papers, this time we present four original research papers, three preliminary communications and three review papers. As previously, the featured papers advocate the thematic diversity of the concerns in the field of education. Furthermore, the papers present innovative, creative and multidisciplinary approaches to researching the issues of education. Through the research results and their interpretation, the presented works offer scientific explanations and understandings as well as predictions and control of the research phenomena in the field of education. Thereby we further develop the interdisciplinary and multidisciplinary direction of the Croatian Journal of Education. In this regard, we still wish you much success in your creative and innovative scientific projects, and we are looking forward to many more of your high-quality papers in 2021. --- Dragi čitatelji!Veliko nam je zadovoljstvo predstaviti vam prvi redovni broj Hrvatskog časopisa za odgoj i obrazovanje u 2021. godini. U ovom broju donosimo deset radova autora iz Bosne i Hercegovine, Hrvatske, Južne Koreje, Srbije, Španjolske i Turske. U pogledu kategorizacije radova, ovaj put predstavljamo četiri izvorna znanstvena rada te tri prethodna priopćenja i tri pregledna rada. Kao i do sada, u prikazanim radovima zastupamo tematsku različitost problematike odgoja i obrazovanja. Također, u radovima su zastupljeni inovativni, kreativni i multidisciplinarni metodološki pristupi istraživanja problematike odgoja i obrazovanja. Rezultatima istraživanja i njihovim interpretacijama, u predstavljenim prilozima ovoga broja, ponuđene su nove i inovativne deskripcije, klasifikacije, definicije, znanstvena objašnjenja i razumijevanja te predikcija i kontrola istraživanih fenomena odgoja i obrazovanja. Time i dalje razvijamo interdisciplinarnost i multidisciplinarnost Hrvatskog časopisa za odgoj i obrazovanje. Stoga nam je iznimno drago što na ovaj način predstavljamo nove znanstvene doprinose istraživanja autora predstavljenih priloga. U tom pogledu, i dalje vam želimo mnogo uspjeha u vašim kreativnim i inovativnim istraživanjima i znanstvenim projektima te se radujemo vašim novim kvalitetnim radovima u 2021. godini.

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