Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

DS, Sandeep; CR, Sowmya; Vadakkepushpakath, Anoop Narayanan; MP, Gowrav

doi:10.5530/jyp.2022.14.7

JYP

2022

DOI: 10.5530/jyp.2022.14.7

|View full text |Cite

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

Sandeep DS¹,

Sowmya CR²,

Anoop Narayanan Vadakkepushpakath³

et al.

Abstract: Generic drug regulations and registration process in IndonesiaIndonesia has a population of about 272.25 million. The drug regulatory authority in Indonesia is the National Agency of Drugs and Food Control (NA-DFC), located in Jakarta, the capital of Indonesia. For the submission of generic drugs to be approved, the ACTD format is followed in Indonesia. 7 The generic drug registration and approval process in Indonesia is described in Figure 2.

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

Supporting

Mentioning

Contrasting

Year Published

2024

Publication Types

Select...

Article1

Relationship

Self Cite0

Independent1

Authors

Journals

Cited by 1 publication

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Generic Drug Registration and Country-Specific Requirements in Saudi Arabia, Qatar, Bahrain, and Oman

J.,

K. M.

2024

Int J Pharm Pharm Sci

View full text Add to dashboard Cite

Objective: This research aims to examine the regulatory framework and prerequisites for generic drug registration in the Middle East and North Africa (MENA) region, with a specific focus on the countries that make up the Gulf Cooperation Council (GCC). This will enable a deeper understanding of the procedures, records, schedules, and discrepancies related to registration. Methods: The study makes use of an extensive examination of the rules, regulations, and practices about the registration of generic drugs in the MENA. Official government sites, regulatory agencies, and respectable trade journals for the pharmaceutical sector were used as sources of information. The main procedures for registering generic drugs were explained and inspected, encompassing the submission of documents, dossier preparation, bioavailability/bioequivalence tests, and application filing. Results: There are substantial growth prospects for generics. Research highlights the sequential registration process for generic drugs, submitting documents electronically using the Common Technical Document (eCTD) method. For registration to be successful, specific records and data such as bioavailability/bioequivalence research data must be provided. Conclusion: The effective registration of generic medications in the MENA region, especially in the GCC nations, depends on understanding and abiding by nation-specific regulatory standards. The research offers a tactical guide that outlines the essential procedures, paperwork needs, and regional variances in the generic medicine registration process. The goal is to offer affordable healthcare solutions by navigating the regulatory landscape meticulously and streamlining the approval and market entry process for generic pharmaceuticals in the MENA region.

show abstract

Generic Drug Registration and Country-Specific Requirements in Saudi Arabia, Qatar, Bahrain, and Oman

J.,

K. M.

2024

Int J Pharm Pharm Sci

View full text Add to dashboard Cite

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

Cited by 1 publication

References 5 publications

Generic Drug Registration and Country-Specific Requirements in Saudi Arabia, Qatar, Bahrain, and Oman

Generic Drug Registration and Country-Specific Requirements in Saudi Arabia, Qatar, Bahrain, and Oman

Contact Info

Product

Resources

About