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.

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 Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia

2020 ◽  
Vol 7 (1) ◽  
pp. 37-44
Author(s):  
Shivani Jani ◽  
Nilesh Patel ◽  
Urvi Chotaliya ◽  
Ashok Patel
Keyword(s):  
European Union ◽  
Union Member ◽  
Regulatory Requirements ◽  
Member States ◽  
Registration Process ◽  
Eu Membership ◽  
Regulatory Guidelines ◽  
Small Countries ◽  
European Union Member States ◽  
The Eu

Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. Method: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guidelines of European Union for pharmaceuticals was carried out. Result: The comparison of guidelines showed that there are still some changes needed in the guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European Union. Some of the points in the guidelines are very different from the guidelines of EU. Conclusion: So it was worthwile to study the regulatory requirements of pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia.

scholarly journals Multicenter Epidemiological Study of Osteoporotic Fractures in Eurasia (EVA Study). A step towards reducing the burden of age-related diseases

2020 ◽  
Vol 22 ◽  
pp. 01019
Author(s):  
Alla Zakroyeva ◽  
Olga Lesnyak ◽  
Sarkis Sahakyan ◽  
Georiy Ramanau ◽  
Viktor Kazak ◽  
...  
Keyword(s):  
Preventive Intervention ◽  
Osteoporotic Fractures ◽  
Population Based ◽  
Fracture Probability ◽  
Population Based Study ◽  
Age Related ◽  
Cis Countries ◽  
Clinical Instrument ◽  
In Cis ◽  
Country Specific

To extend elderly patients’ active longevity, practitioners all over the world need a precise clinical instrument to assess the 10-year osteoporotic fractures probability and choose the optimal preventive intervention. The purpose of this research is to assess major osteoporotic (OP) fractures incidence in CIS countries and to create country-specific computing FRAX clinical prediction tools. Method. We carried out a cohort population-based study (EVA) in Russia, Belarus, Armenia, Moldova, Kazakhstan, and Uzbekistan in 2011-2018. The age- and sexspecific OP fracture incidence values were incorporated into the computing FRAX models. Results. We revealed that the highest standardized HP incidence was obtained in Kazakhstan (338 and 255 per 100 000 per year for women and men older than 50 years resp.) and Moldova (331, 0 and 155, 0 per year for women and men resp.), the lowest in Armenia (201 and 136 per 100 000 per year for women and men resp.). The FRAX models showed that in Kazakhstan, Uzbekistan, and Moldova, elderly people had the highest hip fracture probabilities. Estimates reveal that the OP fractures numbers in the EVA-project countries will grow by 1.5-3 times by 2050. Conclusion. The created national FRAX instruments should enhance the accuracy of determining fracture probability among older people, help clinicians to make decisions concerning OP prophylactic, and to step forward to reducing the burden of age-related diseases.

scholarly journals Registration Process of Medical Devices in CIS Countries

2021 ◽  
Vol 9 (2) ◽  
pp. 35-42
Author(s):  
Ayesha bi Shaik ◽  
G. Ramakrishna
Keyword(s):  
Medical Devices ◽  
Medicinal Products ◽  
Regulatory Requirements ◽  
International Treaty ◽  
Eurasian Economic Union ◽  
Independent States ◽  
The Common ◽  
Economic Union ◽  
Cis Countries ◽  
In Cis

The Commonwealth of Independent States (CIS) is a region with constant, and often quite radical, changes in medical device regulations. This article summarizes the most significant new regulations in the largest CIS countries in order to provide a clearer picture of the regulatory requirements for medical devices in the region. The article also examines the new registration procedure for medical devices placed on the common market within the Eurasian Economic Union (EAEU) in accordance with the International Treaty within the EAEU. This Treaty defines the common principles and rules of circulation of medicinal products and medical devices.

3D Printing in Pharmaceuticals: Regulatory Perspective

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal
Keyword(s):  
New Technologies ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Major Research ◽  
Data Bases ◽  
Drug Products ◽  
Regulatory Perspective ◽  
Regulatory Guidelines ◽  
Recent Developments ◽  
Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

2016 ◽  
Vol 4 (2) ◽  
pp. 1-9
Author(s):  
Lincy Joseph ◽  
Mathew George ◽  
Kalpesh K Malaviya ◽  
Kalpesh K Malaviya ◽  
Bincy K Chacko ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Approval ◽  
Evaluation Agency ◽  
Approval Process ◽  
Registration Process ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Government Websites ◽  
Drug Approval Process ◽  
Regulatory Sites

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements. 

Unemployment and output dynamics in CIS countries: Okun’s law revisited

2016 ◽  
Vol 49 (34) ◽  
pp. 3453-3479 ◽  
Author(s):  
Marat Ibragimov ◽  
Rustam Ibragimov
Keyword(s):  
Okun’S Law ◽  
Okun's Law ◽  
Cis Countries ◽  
In Cis

scholarly journals FACTS ON DRUG REGULATIONS

2018 ◽  
Vol 2 (3) ◽  
pp. 43-47
Author(s):  
Rajkumar Gupta
Keyword(s):  
Life Cycle ◽  
Drug Regulation ◽  
Pharmaceutical Products ◽  
Regulatory Requirements ◽  
Ministry Of Health ◽  
Drug Products ◽  
Drug Regulations ◽  
The Law ◽  
Basic Facts

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

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