A comprehensive study on regulatory requirements for development and filing of generic drugs globally

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

doi:10.4103/2230-973x.104392

Cited by 50 publications

(47 citation statements)

References 2 publications

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“…The regulatory requirements of different countries vary from one another. Therefore, it is challenging for pharmaceutical companies to develop pharmaceutical products which can be simultaneously submitted in every country for approval [5]. Some efforts were undertaken in 2009 by the Obama administration and his Drug Czar Gil Kerlikowske to redress this long-standing imbalance in U.S. drug policy, although the programs remain woefully underfunded [4].…”

Section: In the 21mentioning

confidence: 99%

Drug Approval Regulation: The Global Impacts

Patel¹

2017

JBMOA

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People want prescription drugs to be efficient as well to assist them in treating their ailments. The need of drug regulations was generated in the twentiethcentury as a result of disasters, tragedies, and misfortunes with public health in the past. The legal regulatory document in the form of pharmacopeia came in existence to regulate quality and standard of the medical supplements given to patients. Today, the drug approval criteria in different pharmacopeias differ regionally. Because of the approval process variations, pharmaceutical businesses are facing difficulty in approving new pharmaceutical products for marketing in many countries simultaneously. The review contains regulatory requirements and also, economic and social impacts of variation on pharmaceutical businesses. An effort is made to find solutions by making regulatory requirements globalized.

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Section: In the 21mentioning

confidence: 99%

Drug Approval Regulation: The Global Impacts

Patel¹

2017

JBMOA

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“…Two main regulatory bodies are responsible for the authorization of medical products, namely the FDA in the USA and the EMA in Europe . Both agencies published guidelines to assist the development of medical products in accordance with the law, provided in section 21 of the Code of Federal Regulations (FDA) and Directive 2001/83/EC (EMA), in order to protect consumers’ health and safety.…”

Section: General Demands On Camentioning

confidence: 99%

Status and trends in the development of clinical diagnostic agents

Opacic

Paefgen

Lammers

et al. 2016

WIREs Nanomed Nanobiotechnol

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Contrast agents (CA) are routinely used in clinical practice to improve the diagnosis of diseases and to monitor therapy response. The majority of CA comprises small molecules accumulating at pathological sites due to vascular abnormalities, such as changes in perfusion and permeability. For many diseases, high diagnostic accuracy can be achieved with contrast-enhanced imaging. This means that new CA will only succeed in translation if they either show superior performance with respect to diagnostic accuracy, safety and cost, support a new imaging modality, or are directly linked to the refinement of therapy, e.g., as a companion diagnostic. Unfortunately, these basic demands are often not carefully considered by the scientific community, leading to concepts with low chances of clinical translation. Thus, it is not surprising that, despite steadily increasing numbers of publications, there is quite the opposite trend when it comes to the clinical approval of new diagnostics. As a matter of fact, except for PET tracers, in the last decade, only a handful of CA received FDA or EMA approval. Furthermore, several approved products were discontinued by the manufacturers because of low market potential, a competitive own product, suboptimal clinical performance, or safety concerns. This review article discusses the current status of approved diagnostic probes for clinical imaging modalities, with a focus on new trends in CA development. In this context, molecularly targeted diagnostics or probes for emerging fields, such as image-guided surgery, nanomedicine, or theranostics, will be introduced and discussed with regard to their clinical translation. WIREs Nanomed Nanobiotechnol 2017, 9:e1441. doi: 10.1002/wnan.1441 For further resources related to this article, please visit the WIREs website.

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“…The country-specific regulatory requirements are summarized in Table V [ [17][18][19][20]. These guidelines are quite similar across various countries apart from the minor variations in number of exhibit batches and minimum stability requirement.…”

Section: N O M E N C L a T U R E O F I N N O V A T O R M E D I C I N mentioning

confidence: 99%

“…These guidelines are quite similar across various countries apart from the minor variations in number of exhibit batches and minimum stability requirement. The country-specific regulatory requirements are summarized in Table V [ [17][18][19][20].…”

Section: Generic Medicinesmentioning

confidence: 99%

Generic medicines: issues and relevance for global health

Rana

Roy

2015

Fundamemntal Clinical Pharma

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Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide.

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A comprehensive study on regulatory requirements for development and filing of generic drugs globally

Cited by 50 publications

References 2 publications

Drug Approval Regulation: The Global Impacts

Drug Approval Regulation: The Global Impacts

Status and trends in the development of clinical diagnostic agents

Generic medicines: issues and relevance for global health

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