Regulatory Requirements for Pharmaceutical Product Registration in UAE

Year : 2024 | Volume :11 | Issue : 01 | Page : 1-7
By

    Achin Jain

  1. Neenu Ganesh

  1. Manager, Procter and Gamble Home Product Private Limited, Mumbai, Maharashtra, India
  2. Associate Professor, Oriental College of Pharmacy, Navi Mumbai, Maharashtra, India

Abstract

Over the past decade, the healthcare industry in the United Arab Emirates (UAE) has experienced remarkable growth, positioning itself as the second-largest healthcare industry in the Middle East, trailing only Saudi Arabia. Recognizing the significance of healthcare, the UAE government has prioritized its development and actively promoted it as part of the national development plan. The Ministry of Health (MOH) has played a crucial role in this endeavor by allocating substantial funds to the public sector and focusing on the private market. The UAE has become an attractive market for pharmaceutical and healthcare industries due to several factors. Firstly, the country has witnessed a rise in public and private wealth, primarily driven by the oil boom, resulting in increased healthcare spending. Additionally, the UAE has a strong and continuously improving healthcare infrastructure that enables the delivery of high-quality healthcare services. Moreover, the UAE has established a relatively favorable regulatory environment, facilitating the approval process for pharmaceutical companies to introduce their medicines. This regulatory landscape, combined with the absence of significant local competitors, has made the UAE a desirable market for pharmaceutical and healthcare industries. The objectives of the mentioned study are to provide a comprehensive understanding of the organizational structure of the Ministry of Health (MOH) in the UAE. Additionally, the study aims to offer insights into the pharmaceutical regulatory body in the UAE and provide information on the registration requirements for pharmaceutical products. In summary, the healthcare industry in the UAE has witnessed significant growth, supported by government initiatives, increased healthcare spending, and a favorable regulatory environment. The study seeks to provide valuable insights into the organizational structure of the MOH, the pharmaceutical regulatory framework, and the registration process for pharmaceutical products in the UAE.

Keywords: United Arab Emirates (UAE), (HAAD) health authority – Abu Dhabi, (DHA) Dubai health authority, (NDA) national defense academy, (CTD) common technical document modules.

[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]

How to cite this article: Achin Jain, Neenu Ganesh.Regulatory Requirements for Pharmaceutical Product Registration in UAE.Research & Reviews: A Journal of Drug Formulation, Development and Production.2024; 11(01):1-7.
How to cite this URL: Achin Jain, Neenu Ganesh , Regulatory Requirements for Pharmaceutical Product Registration in UAE rrjodfdp 2024 {cited 2024 Mar 15};11:1-7. Available from: https://journals.stmjournals.com/rrjodfdp/article=2024/view=141134


Browse Figures

References

1.United Arab Emirates – Country Commercial Guide. [Online] Available from: https://www.trade.gov/country-commercial-guides/united-arab-emirates-healthcare-and-life-science [accessed on 11 Feb 2024]
2.Ministry of Health, UAE. Organization Structure. [Online] Available from: https://mohap.gov.ae/en/about-us/organization-structure [accessed on 11 Feb 2024]
3.Registration of a Conventional Pharmaceutical Product [Online] Available from: https://mohap.gov.ae/en/services/registration-of-a-conventional-pharmaceutical-product [accessed on 11 Feb 2024]
4.Renewal of Registration of a Conventional Pharmaceutical Product [Online] Available from: https://mohap.gov.ae/en/services/renewal-of-registration-of-a-conventional-pharmaceutical-product [accessed on 11 Feb 2024]
5.Minor Variation for Registered pharmaceutical product in UAE. [Online] Available from: https://www.khidi.or.kr/fileDownload?titleId=259380&fileId=1&fileDownType=C&paramMenuId=MENU01872 [accessed on 11 Feb 2024]
6.UAE pharmaceutical industry set to benefit from lifestyle changes. [Online] Available from: https://www.thepharmaletter.com/article/uae-pharmaceutical-industry-set-to-benefit-from-lifestyle-changes [accessed on 11 Feb 2024]
7.Urbanization: regional trends [Online] Available from: https://www.undp.org/sites/g/files/ zskgke326/files/migration/arabstates/MainReportScreen-30-46.pdf [accessed on 11 Feb 2024]
8.Jain A, Ganesh N. Post Approval Life Cycle Management of Variations for Generic Drugs in Brazil. Research & Reviews: A Journal of Drug Formulation, Development and Production . 2017; 4(1 6p.
9.Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Drug Product in China. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 1–6p.
10.Fletcher J, Ahmed M, Pharo C. ASEAN-China drug development. A comparison of ASEAN and Chinese drug registration requirements. In: Regulatory Rapporteur; 2010: 9(7/8).


Regular Issue Subscription Original Research
Volume 11
Issue 01
Received January 13, 2024
Accepted January 24, 2024
Published March 15, 2024