Export Registration of Pharmaceuticals in Rest of World Countries (Row)

Badjatya, Jitendra Kumar; Bodla, Ramesh Babu; Musyuni, Pankaj

doi:10.22270/jddt.v3i1.391

Cited by 4 publications

(3 citation statements)

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“…The reduction of duplication of effort and accelerated market access without compromising safety standards will benefit both the industry and patients. Additionally, it would make it easier for regulatory agencies to work together more closely, which might improve information sharing and mutual recognition of approvals [43] [44]. Understanding regulatory methods has a tremendous impact on the larger public health context.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Regulatory Strategies for Generic Product Approval across Asian Nations

Nelavala

2024

Int. J.Exp. Biomed. Res.

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The pharmaceutical industry is critical for providing accessible, affordable healthcare globally. This study compares regulatory strategies for generic drug approvals in Europe and Asia, focusing on India, China, and Japan. It analyzes legal frameworks, evaluation criteria, data requirements, and approval timelines, aiming to understand the impact on the efficiency of generic drug market entries in these regions. The research methodology includes reviewing regulatory guidelines, legislative documents, scholarly publications, and conducting interviews and surveys with industry experts. Preliminary findings reveal significant differences in the legal and procedural requirements across Asian nations, with variations in the emphasis on local clinical data and approval timelines. These disparities affect market accessibility, competition, and healthcare affordability. Insights from this study are vital for pharmaceutical companies navigating international markets and for policymakers aiming to harmonize and expedite approval processes, ultimately improving global access to cost-effective healthcare solutions.Top of Form

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Section: Discussionmentioning

confidence: 99%

Analysis of Regulatory Strategies for Generic Product Approval across Asian Nations

Nelavala

2024

Int. J.Exp. Biomed. Res.

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“…Based on that, the patients will need more medicines expanding the market for pharmaceuticals in the country. Portuguese Agencia Nacional de Vigilance Sanitaria, commonly referred to as ANVISA, is the name of the Brazilian Health Surveillance Agency 22,23 the Brazilian Regulatory Authority ANVISA is that is liable for approval and surveillance of foods, medicines, cosmetics, tobacco, public health, medical devices and maintaining cleanliness of ports, airports 24,25 For the registration of pharmaceuticals (innovator, generic, and comparable drugs) in Brazil, RDC No. 60/ 2014 was published in 2014.…”

Section: Latin Americamentioning

confidence: 99%

Regulatory framework and disparities of complex generics in United States, European Union & Latin America

Bhatt,

Tank,

Shah

et al. 2023

Journal of Generic Medicines

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The regulatory agencies all over the world have defined the pathway and the regulations for approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for approval of biosimilar. According to this viewpoint, the approval of complex generics, also known as non-biological complex pharmaceuticals, is not subject to any clearly defined regulations (NBCDs). Although they differ from biologic products, complex medicines are constructed of huge, extremely complex, and synthetic components. The regulatory frameworks that are currently being used for complicated generics are opaque and uncertain. The market for complex generics is huge and there are fewer generic competitors in this area. In addition, the cost of bringing such generics into the market is high. Thus, there is a need for a well-defined pathway and guidance documents for the authorization of generic versions of complex drug products. The paper focus on the regulatory frameworks that the USA, EU, and Latin America have developed at this time to allow for the introduction of complicated generics to the market. In order to analyse regulatory policies in the USA, Europe, and Latin America for the marketing of NBCD copies, a case study of a product with an approved generic version is used. It also describes on the regulatory disparities existing among the three agencies in the light of complex generics.

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“…Gulf Co-operation Council Countries are also called Middle East Countries i.e. Bahrain, Qatar, Saudi Arabia, UAE and Kuwait [14]. The import of superior drug products is under the control of Gulf Countries [15].…”

Section: Modulesmentioning

confidence: 99%

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

Mohit

2019

ACCTRA

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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.

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Export Registration of Pharmaceuticals in Rest of World Countries (Row)

Cited by 4 publications

References 0 publications

Analysis of Regulatory Strategies for Generic Product Approval across Asian Nations

Analysis of Regulatory Strategies for Generic Product Approval across Asian Nations

Regulatory framework and disparities of complex generics in United States, European Union & Latin America

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

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