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 An overview on comparative study of registration requirements for generics in US, Canada and Europe

2020 ◽  
Vol 1 (4) ◽  
pp. 117-123
Author(s):  
Suryawanshi Meghraj ◽  
Jain minal
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Technical Requirements ◽  
Generic Drug Product ◽  
Similarities And Differences ◽  
Drug Approval Process ◽  
Country Specific

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

Review of Open Source Software (OSS)

2012 ◽  
pp. 26-40
Author(s):  
Bhasker Mukerji ◽  
Ramaraj Palanisamy
Keyword(s):  
Developing Countries ◽  
Public Sector ◽  
Open Source ◽  
Open Source Software ◽  
Low Cost ◽  
Source Code ◽  
Developed Countries ◽  
Economic Resources ◽  
Large Pool ◽  
Public Sector Organizations

The popularity of Open Source Software (OSS) in developing countries is quiet evident from its widespread adoption across government departments and public sector organizations. The use of OSS saves economic resources of cash starved countries, provides an opportunity to promote e-government, and to utilize their resources in other sectors. Many developing countries have a large pool of skilled developers who can modify the source code of the OSS at a very low cost. Many governments in developing and developed countries have switched to OSS which probably encourages others to follow the trend. It was not possible to follow the adoption trend in all the developing countries but the usage of OSS in countries like India, Brazil, and Venezuela provides us an insight. The successful adoption of OSS requires thorough analysis of its advantages as well as the issues associated with it. This chapter will provide an overview of OSS, characteristics of OSS developers, and their motivation to volunteer by contributing in OSS projects, followed by the advantages and issues associated with OSS.

Review of Open Source Software (OSS)

2011 ◽  
pp. 198-212
Author(s):  
Bhasker Mukerji ◽  
Ramaraj Palanisamy
Keyword(s):  
Developing Countries ◽  
Public Sector ◽  
Open Source ◽  
Open Source Software ◽  
Low Cost ◽  
Source Code ◽  
Developed Countries ◽  
Economic Resources ◽  
Large Pool ◽  
Public Sector Organizations

The popularity of Open Source Software (OSS) in developing countries is quiet evident from its widespread adoption across government departments and public sector organizations. The use of OSS saves economic resources of cash starved countries, provides an opportunity to promote e-government, and to utilize their resources in other sectors. Many developing countries have a large pool of skilled developers who can modify the source code of the OSS at a very low cost. Many governments in developing and developed countries have switched to OSS which probably encourages others to follow the trend. It was not possible to follow the adoption trend in all the developing countries but the usage of OSS in countries like India, Brazil, and Venezuela provides us an insight. The successful adoption of OSS requires thorough analysis of its advantages as well as the issues associated with it. This chapter will provide an overview of OSS, characteristics of OSS developers, and their motivation to volunteer by contributing in OSS projects, followed by the advantages and issues associated with OSS.

scholarly journals Physician’s role in prescribing opioids in developing countries

2019 ◽  
Vol 12 (6) ◽  
pp. e227072 ◽  
Author(s):  
Jorge A Roa ◽  
Alexandra Guevara ◽  
Carolina Guevara ◽  
Jaime Guevara-Aguirre
Keyword(s):  
Chronic Pain ◽  
Developing Countries ◽  
Preventive Measures ◽  
Low Cost ◽  
Developed Countries ◽  
Current Data ◽  
Standard Methods ◽  
Analgesic Effects ◽  
Normal Individuals ◽  
Definite Role

In developed countries, addressing the growing opioid addiction epidemic is focused on preventive measures, developing better overdose-reversal medications and designing newer strategies to treat addiction. Primary prescribers of the therapeutic use of opioids might play a definite role in the aetiology of the epidemics. Developing countries could be affected by similar issues; however, given that no updated statistics are available, it is possible that their populations undergo problems similar to those for which current data is available. Concerns have arisen regarding synthetic opioid tramadol which, given its fast and potent analgesic effects, low cost and easy availability is widely prescribed. A debate remains as to whether tramadol induces addictive effects like those of stronger analogues such as oxycodone or fentanyl. Here we present a case of tramadol dependence in an Ecuadorian patient and find that substance abuse can occur in normal individuals affected by chronic pain, otherwise treatable with standard methods.

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 Accounting systems in developing countries under sustainability: first glance from Ukraine and Ghana

2018 ◽  
Vol 2 (1) ◽  
pp. 37-46
Author(s):  
Inna Makarenko ◽  
Stephen Adu
Keyword(s):  
Sustainable Development ◽  
Developing Countries ◽  
Comparative Study ◽  
Stakeholder Participation ◽  
Sustainability Reporting ◽  
Developed Countries ◽  
Conceptual Frameworks ◽  
Integrated Reporting ◽  
Regulatory Requirements ◽  
Accounting Systems

The dissemination of sustainability reporting and integrated reporting is a key trend in the development of accounting systems under the influence of the concept of sustainable development. This statement is fair not only for developed countries, but also for developing countries. On the example of Ghana and Ukraine, a comparative study of regulatory requirements and conceptual frameworks for the compilation of sustainability reporting and integrated reporting has been conducted; the dynamics, size of reporting companies, their sectoral affiliation and the standards used are researched. It was proved that the basis for the promotion sustainability reporting and integrated reporting in these countries are regulatory requirements, as well as increasing the perception of CSR, the transparency and accountability of business, the practices of stakeholder participation and assurance the reliability of reporting for stakeholders.

scholarly journals SOCIAL SATIRE ON HIGHER EDUCATION: A COMPARATIVE STRUCTURAL SEMIOTIC STUDY OF THE MOVIES ALANGKAH LUCUNYA (NEGERI INI) AND PARASITE

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yulianeta Yulianeta ◽  
Rosmah Tami
Keyword(s):  
Higher Education ◽  
Developing Countries ◽  
Social Class ◽  
Educational System ◽  
Developed Countries ◽  
Common Belief ◽  
Semiotic Analysis ◽  
The Poor ◽  
Similarities And Differences ◽  
The Rich

It is commonly believed that obtaining a higher education is one way to elevate people's social class. Two movies, the Indonesian film Alangkah Lucunya (Negeri Ini) ALNI (2010) and the Korean Parasite (PR) (2019), challenge this common belief. The two movies criticize higher education by conveying the message in satire. To unveil the meaning of the two movies' social satires, this study used Roland Barthes's structural semiotic analysis on five primary codes to explore the codes that regulate the structure of the narrative of the text (film) to find similarities and differences of their focus of criticism regarding higher education. The use of satiric form to contrast and juxtapose the rich and the poor, and the educated and uneducated shows that both Alangkah Lucunya (Negeri Ini)  and Parasite uncover the influence of neoliberalism in the formal educational system that gives an impact to both lower and higher class, either in developed countries or developing countries. The satire content is intended to attract attention and to inspire people to move to change the situation.

Evolution of Low Technology Waste Water Disposal in the Developed Countries and Its Implication for the Developing Nations

1986 ◽  
Vol 18 (7-8) ◽  
pp. 59-62
Author(s):  
Robert W. Seabloom ◽  
Dale A. Carlson
Keyword(s):  
Developing Countries ◽  
Drinking Water ◽  
Low Cost ◽  
Developed Countries ◽  
Developing Nations ◽  
Safe Water ◽  
Lofty Goal ◽  
The Developed Countries ◽  
Sanitation Systems ◽  
Developed Nations

The majority of people in developing countries are without reasonable access to safe drinking water and are forced to live without proper sanitation. This lack of safe water and poor sanitation is the major cause of untold misery, disability, disease and death. The United Nations declared the 1980's as the “International Drinking Water Supply and Sanitation Decade” with the lofty goal of safe water and adequate sanitation for all by 1990. Realizing it required about 150 years for sanitation systems to evolve in the developed nations, it is important that the developing nations learn from their mistakes. The future sanitation systems for developing countries must use appropriate low cost technologies, rather than the conventional high cost water carriage sewerage technology of the developed nations. These low cost solutions when properly sited, designed, constructed and maintained are no less prestigious and as the overall environmental impacts become understood are in many instances the preferred solution.

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