Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries

2020 ◽  
Vol 7 (2) ◽  
pp. 117-125
Author(s):  
Mohit ◽  
Aakash Deep ◽  
Gaurav Khurana ◽  
Jagdeep Kumar ◽  
Akshay Monga
Keyword(s):  
Latin American ◽  
Drug Product ◽  
Emerging Market ◽  
Pharmaceutical Companies ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Regulatory Development ◽  
In Cis ◽  
Regulatory Organization ◽  
Latin American Countries

The product registration in the rest of the World is a challenging task because the regions under it are not harmonized. CIS and Latin American regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. Both the regions follow their regional checklist for Drug Product Registration. Latin America includes a group of countries like Brazil, Guatemala and Peru etc, whereas CIS includes Russia, Ukraine, Uzbekistan, Armenia and Tajikistan etc.

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

2019 ◽  
Vol 6 (1) ◽  
pp. 62-70 ◽  
Author(s):  
Mohit ◽  
Aakash Deep ◽  
Gaurav Khurana ◽  
Jagdeep Kumar ◽  
Akshay Monga
Keyword(s):  
Saudi Arabia ◽  
Drug Product ◽  
Emerging Market ◽  
Review Article ◽  
Pharmaceutical Companies ◽  
Pharmaceutical Drugs ◽  
Regulatory Requirements ◽  
The World ◽  
Regulatory Development ◽  
Regulatory Organization

Background: The product registration in rest of the world is a challenging task because they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. ASEAN used ACTD format and GCC used ICH CTD format for drug product Registration. ASEAN includes a group of countries like Singapore, Philippines etc. Whereas GCC includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE. Conclusion: This review article focuses on general regulatory requirements of registration of pharmaceuticals in ASEAN and GCC region.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Politics and Governance in Emerging Market Countries

2021 ◽  
pp. 097491012110043
Author(s):  
Min Liu
Keyword(s):  
Economic Growth ◽  
Latin American ◽  
Good Governance ◽  
Emerging Market ◽  
Critical Factor ◽  
Political Stability ◽  
Asian Countries ◽  
Emerging Market Countries ◽  
Future Improvement ◽  
Latin American Countries

The rise of emerging market countries is of great significance for improving global governance. This study finds that 30 emerging market countries (E30) 1 , especially those in Africa and Asia, are relatively weak in governance. In the future, improvement in governance would be a critical factor for the economic growth of E30 countries, especially if these countries enjoy political stability. Though most of the E30 countries lack political stability, they have the capability for good governance, and their governments are striving to become more effective, which is particularly true for Asian countries. Unfortunately, for Latin American countries, corruption is a serious problem likely to undermine economic development in the region.

scholarly journals Private Regulierung der Weltwirtschaft

2006 ◽  
Vol 36 (142) ◽  
pp. 127-143
Author(s):  
Ingo Malcher
Keyword(s):  
Latin American ◽  
Emerging Market ◽  
Governance Structure ◽  
Strong Impact ◽  
Private Institutions ◽  
Private Governance ◽  
Private Regulation ◽  
Rating Agencies ◽  
Latin American Countries ◽  
The International Monetary Fund

Alongside with the liberalization of financial markets organizations of private regulation have become more important since the nineties. Private institutions such as Rating Agencies or financial market instruments as the Emerging Market Bond Index (EMBI+) are part of the private governance structure and have a strong impact on countries’ economic, financial and social policy and in some cases have become more important than has the International Monetary Fund (IMF) or the World Bank. Especially for the new leftwing governments of Latin America, which have emerged around the millenium change, these mechanisms and instruments of private regulation are of strong importance as they are still backing neoliberal hegemony although there is a crisis of the neoliberal consensus within the continent. These instruments should therefore be seen as enforcement measures of the neoliberal hegemony because they make sure that Latin American countries are employing market friendly policies.

scholarly journals Drug Registration requirements for Pharmaceuticals in Emerging markets

2020 ◽  
Vol 8 (4) ◽  
pp. 73-82
Author(s):  
Sri Lakshmi Sowjanya Reddy Singam ◽  
Koushik Yetukuri ◽  
Rama Rao Nadendla
Keyword(s):  
Drug Product ◽  
Emerging Market ◽  
Technical Document ◽  
Regulatory Requirement ◽  
Drug Products ◽  
Technical Requirements ◽  
Drug Registration ◽  
Pharmaceutical Enterprise ◽  
Pharmaceutical Industries ◽  
Human Use

Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.

scholarly journals Comparative study of Regulatory requirements of Drug Product in Emerging market

2019 ◽  
Vol 7 (3) ◽  
pp. 48-62
Author(s):  
Preeti Patel ◽  
Jitendra Kumar Badjatya ◽  
Madhuri Hinge
Keyword(s):  
Drug Product ◽  
Emerging Market ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Technical Requirements ◽  
Regional Registration ◽  
Drug Registration ◽  
Pharmaceutical Industries ◽  
Requirements Quality ◽  
Human Use

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

scholarly journals Regulatory requirements for Drug master file in context to Canada and Australia

2018 ◽  
Vol 6 (2) ◽  
pp. 41-47
Author(s):  
Meghna Danej ◽  
Ronak Dedania ◽  
Sanket Gandhi ◽  
Juhi Randeria ◽  
Kankrej Gaurav
Keyword(s):  
Drug Product ◽  
Electronic Format ◽  
Regulatory Requirements ◽  
Master File ◽  
Drug Products ◽  
Eu Legislation ◽  
New Drug ◽  
Regulated Markets ◽  
Clear Idea

Drug Master Files are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Canada and Australia which are consider as highly regulated markets (HRMs). In CANADA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product MFs. In AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. They consist of eight phase for DMF registration. Where EU guidelines adopted in Australia include references to EU legislation. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission. Compare DMF regulatory requirements in the above-mentioned countries so that reader can have clear idea on how to file DMF.

Test Use in Spain, Portugal and Latin American Countries

1999 ◽  
Vol 15 (2) ◽  
pp. 151-157 ◽  
Author(s):  
José Muñiz ◽  
Gerardo Prieto ◽  
Leandro Almeida ◽  
Dave Bartram
Keyword(s):  
Latin American ◽  
Ad Hoc ◽  
Task Force ◽  
Test Construction ◽  
European Federation ◽  
Psychometric Characteristics ◽  
Testing Practices ◽  
Professional Psychologists ◽  
Test Use ◽  
Latin American Countries

Summary: The two main sources of errors in educational and psychological evaluation are the lack of adequate technical and psychometric characteristics of the tests, and especially the failure to properly implement the testing process. The main goal of the present research is to study the situation of test construction and test use in the Spanish-speaking (Spain and Latin American countries) and Portuguese-speaking (Portugal and Brazil) countries. The data were collected using a questionnaire constructed by the European Federation of Professional Psychologists Association (EFPPA) Task Force on Tests and Testing, under the direction of D. Bartram . In addition to the questionnaire, other ad hoc data were also gathered. Four main areas of psychological testing were investigated: Educational, Clinical, Forensic and Work. Key persons were identified in each country in order to provide reliable information. The main results are presented, and some measures that could be taken in order to improve the current testing practices in the countries surveyed are discussed. As most of the tests used in these countries were originally developed in other cultures, a problem that appears to be especially relevant is the translation and adaptation of tests.

Test movement in Ibero-Latin American countries

2010 ◽  
Author(s):  
Solange Muglia Wechsler ◽  
Maria Perez Solis ◽  
Conceicao Ferreira ◽  
Isabel Magno ◽  
Norma Contini ◽  
...  
Keyword(s):  
Latin American ◽  
Latin American Countries
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