STUDY ON REGISTRATION AND REGULATORY REQUIREMENTS FOR VACCINES IN USA, EUROPE AND CANADA

2020 ◽  
Vol 9 (4) ◽  
Author(s):  
Shoukat Ali ◽  
Shanthakumar GS ◽  
Shrikanth P ◽  
Ayushi Agrawal ◽  
Navya BR
Keyword(s):  
European Medicines Agency ◽  
Pharmacovigilance System ◽  
Regulatory Requirements ◽  
Biological Preparation ◽  
Biologics License Application ◽  
License Application ◽  
Regulatory Guidelines ◽  
Post Marketing ◽  
Protection Efficacy ◽  
Health Canada

In recent years vaccines are the foremost necessary health intervention globally. An immunizing agent could also be a biological preparation that will increase the immunity to a specific wellness. The development of an immunizing agent could be a posh and tedious method. A strict regulatory guidelines used to figure out the protection, efficacy, and quality should be achieved throughout the development of a vaccine for its authorization. In USA biologics were regulated by the Centre for Biologics Evaluation and Research (CBER) beneath USFDA. In Europe, European Medicines Agency (EMA) regulates the biologics and authorization is granted by the European Commission (EC). In Canada, vaccines are regulated by Biologics and Genetics Therapy Directorate (BGTD) under Health Canada (HC). For Registration of vaccine, Biologics license application (BLA) in USA, marketing authorization application (MAA) in EU and New Drug Submission (NDS) Application in Canada ought to be submitted. While registration of a vaccine, post-marketing surveillancestudies such as VAERS should be done in USA, Pharmacovigilance system in Europe and Canadian Adverse Events Following immunization surveillance system (CAEFISS) in Canada monitors the safety of a vaccine.

Anti-TNFs: Originators and Biosimilars

2016 ◽  
Vol 34 (1-2) ◽  
pp. 132-139 ◽  
Author(s):  
Gerassimos J. Mantzaris
Keyword(s):  
First Generation ◽  
Legal Framework ◽  
European Medicines Agency ◽  
In Vitro Tests ◽  
Necrosis Factor Alpha ◽  
Comparability Exercise ◽  
Post Marketing ◽  
The Cost ◽  
Health Canada

In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFα) biologics has revolutionized the treatment of patients with inflammatory bowel disease (IBD) but the cost of biologic therapy now constitutes a large proportion of all healthcare expenditures. Patent expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce a highly similar version of the reference product. Similarity in structure, physicochemical properties, biologic activity, efficacy and safety must be demonstrated by a comprehensive comparability exercise that includes the most sensitive in vitro tests, models and clinical condition with pre-defined equivalence margins. Extrapolation of indications, inter-changeability and automatic substitution between BS and ORG depend on a legal framework that varies between different agencies. It is not, therefore, unexpected that marketing authorization by the European Medicines Agency and other regulatory agencies (but not Health Canada) of CT-P13 (Remsima™/Inflectra™) as infliximab (Remicade®) BSs for IBD by indication extrapolation has led to stormy discussions in the IBD community and beyond regarding the scientific adequacy of this decision. However, as we now have to live with BSs, we hope that the impeding automatic substitution in association with post-marketing pharmacovigilance, full traceability, registries and new studies will settle the controversy and will increase the confidence of physicians and patients. A universally adopted legal framework should be implemented because, as expected, the non-anti-TNFα BSs will be soon on the stage.

scholarly journals Regulatory Perspectives on Biopharmaceuticals for Chronic Inflammatory Diseases in North Africa: A Narrative Review

2019 ◽  
Vol 13 (1) ◽  
pp. 72-84
Author(s):  
Ouafa Mkinsi ◽  
Salima Lefkir-Tafiani ◽  
Héla S, Srairi ◽  
Samir Kochbati ◽  
Yasser M. El Dershaby ◽  
...  
Keyword(s):  
North Africa ◽  
Lower Cost ◽  
Inflammatory Diseases ◽  
Chronic Inflammatory Disease ◽  
World Health ◽  
European Medicines Agency ◽  
Regulatory Requirements ◽  
Access To Treatment ◽  
Chronic Inflammatory Diseases ◽  
Post Marketing

Introduction of innovative biopharmaceuticals has dramatically changed the treatment of chronic inflammatory diseases, but access to these very effective agents may be limited by economic constraints in some regions. The development of biosimilar products at a lower cost may allow wider access to treatment, but rigorous scientific evaluation is required to ensure similar quality, efficacy, and safety. The World Health Organization, European Medicines Agency, and United States Food and Drug Administration have created stringent guidelines for biosimilar regulatory approval, stipulating that high similarity be demonstrated in comprehensive comparability studies. Although these regulatory standards have been adapted in many countries, the legal/regulatory frameworks required for biosimilar authorization remain in development elsewhere, including North Africa. In some countries, “intended copies” are available despite inadequate evidence of comparability to the reference product and failure to satisfy biosimilar regulatory requirements. In North Africa, as the regulatory pathway for biosimilars is established, regulators will address several important challenges, including criteria for comparability, switching/substitution, post-marketing monitoring/risk management, and product naming conventions. Caution is advised to ensure that lower cost and broader access are not achieved at the expense of patient safety, and educational initiatives should be undertaken for clinicians/patients. In this review, we define the various types of biopharmaceuticals currently available for the treatment of chronic inflammatory disease, provide an overview of regulatory requirements for biosimilar approval and an update on the availability of these agents globally and in North Africa, and discuss crucial concerns related to their use from the viewpoint of North African rheumatologists.

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.

scholarly journals Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

2020 ◽  
Vol 11 ◽  
pp. 204209862090961
Author(s):  
Marina A. Malikova
Keyword(s):  
Pharmaceutical Industry ◽  
Health Professionals ◽  
Case Reports ◽  
Individual Case ◽  
Regulatory Requirements ◽  
Practical Applications ◽  
Safety Alert ◽  
Potential Safety ◽  
Post Marketing ◽  
Regulatory Decisions

Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, 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.

Werberecht und Absatzförderung/Preisrecht

2019 ◽  
Keyword(s):  
German Law ◽  
Pharmaceutical Products ◽  
Economic Feasibility ◽  
Sales Promotion ◽  
Insurance Companies ◽  
European Medicines Agency ◽  
Regulatory Requirements ◽  
Eu Directive ◽  
Health Insurance Companies ◽  
Advertising Law

The first lecture given at the 21st Marburg debates on pharmaceutical law addressed the criminal consequences of advertising law going hand in hand with sales promotion. It focused on clarifying which forms of cooperation are still desirable, necessary and allowed. In addition to dealing with the regulatory requirements involved in the contractual organisation of digital communication channels and the legal options offered by the information conveyed, among others, by health insurance companies about the economic feasibility of regu-lations on medication, the conference also highlighted the opportunities offered by fiscally optimised sales models for medical products. This main subject of discussion also encompassed upholding the EU directive on the protection of know-how on the publication of registration documentation by the European Medicines Agency. Pricing laws constituted a further main point of discussion at the conference, with issues re-lating to mixed pricing, the possibility of being exempt from factory discounts, the effects of the German law on increasing the provision of pharmaceutical products on forms of treatment with cytostatic agents, and the provision of discounts being addressed. With contributions by Dr. Manja Epping, Dr. Jan-Tobias Häser, Prof. Josef Hecken, Christian Hübner, Dr. Elmar Mand, Dr. Constanze Püschel, Dr. Christoph Ritzer, Dr. Stefan Todt, Peter von Czettritz, Wolfgang Voit

scholarly journals Regulatory aspects for Biologic Product licensing in Australia

2019 ◽  
Vol 7 (2) ◽  
pp. 1-6
Author(s):  
Sanjeev Kumar Maurya ◽  
Vikesh Kumar Shukla ◽  
Sunny Kumar Maurya ◽  
Prachi Kaushik
Keyword(s):  
Human Cells ◽  
Human Tissues ◽  
Animal Cells ◽  
Regulatory Requirements ◽  
Live Animal ◽  
Regulatory Aspects ◽  
Physiological Processes ◽  
Market Authorization ◽  
Regulatory Guidelines ◽  
Biologic Product

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.

scholarly journals The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation

2018 ◽  
Vol 9 (10) ◽  
pp. 601-608 ◽  
Author(s):  
Begoña Calvo ◽  
Javier Martinez-Gorostiaga ◽  
Enrique Echevarria
Keyword(s):  
Analytical Techniques ◽  
Cost Effective ◽  
Management Plan ◽  
European Medicines Agency ◽  
Complex Nature ◽  
Regulatory Requirements ◽  
Regulatory Issues ◽  
Cost Effective Alternative ◽  
Safety Considerations ◽  
Improve Patient

The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration. The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance activities, especially in the post-approval period. This paper addresses regulatory issues related to the approval of biosimilars in Europe associated with safety considerations linked to the development and use of these medicines. We also discuss the issues of immunogenicity, interchangeability and traceability of biological medicines.

scholarly journals REGULATORY GUIDELINES FOR APPROVAL OF BIOSIMILARS IN INDIA, EUROPE, BRAZIL AND CHINA: A COMPREHENSIVE OVERVIEW

2016 ◽  
Vol 8 (10) ◽  
pp. 7 ◽  
Author(s):  
Meenakshi K. Chauhan ◽  
Shipra Malik
Keyword(s):  
Medicinal Product ◽  
Phase 1 ◽  
European Medicines Agency ◽  
Biological Product ◽  
Comprehensive Overview ◽  
Two Phase ◽  
Regulatory Guidelines ◽  
Comparability Exercise ◽  
Biological Medicinal Product

<p>A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference biological product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise. EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in 2010 in Brazil and 2012 in India. Recently China published its guideline for biosimilar approval in 2015.</p><p>This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, Brazil, and China. These countries require comparability exercise of a biosimilar with reference biological product for generating comparative analytical, non-clinical and clinical data (usually one or two phase 1 and phase 3 comparative studies). A case study of infliximab biosimilar approval in India, Brazil and Europe has also been included.</p>

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