• Home
  • Browse Issues
    • In Press
    • Current Issue
    • Special Issue
    • Past Issues
  • About
    • Editorial Board
    • Bibliographic Listings
    • Peer Review Process
    • Open Access Policy
    • Plagiarism Policy
    • Copyright Policy
    • Retraction Policy
    • Editorial Policy
    • Disclaimer
  • Author Guidelines
  • Submit Article
  • Contact

Subscribe to Updates

Get the latest creative news from FooBar about art, design and business.

Facebook Twitter Instagram
International Journal of Pharmaceutical Investigation
Facebook Twitter Instagram
Submit Article Author Guidelines
  • Home
  • Browse Issues
    1. In Press
    2. Current Issue
    3. Special Issue
    4. Past Issues
    5. View All

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023
  • About
    • Editorial Board
    • Bibliographic Listings
    • Peer Review Process
    • Open Access Policy
    • Plagiarism Policy
    • Copyright Policy
    • Retraction Policy
    • Editorial Policy
    • Disclaimer
  • Author Guidelines
  • Submit Article
  • Contact
International Journal of Pharmaceutical Investigation
Home»JPHI»Vol 13 Issue 3»How Generic Drugs are Registered in Europe, United Kingdom, Australia and New Zealand? – A Drug Regulatory Perspective
Vol 13 Issue 3

How Generic Drugs are Registered in Europe, United Kingdom, Australia and New Zealand? – A Drug Regulatory Perspective

July 5, 2023Updated:July 7, 20232 Mins Read
Share
Facebook Twitter LinkedIn Pinterest WhatsApp Email

International Journal of Pharmaceutical Investigation, 2023,13, 3, 440-445.
DOI: 10.5530/ijpi.13.3.055
Published: July 2023
Type: Review Article

Authors: 

Sandeep DS
Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, Karnataka, INDIA

Lavanya YK
Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru, Karnataka, INDIA

Shailesh T
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.

ABSTRACT

The present study describes the process of regulatory submission and generic drug registration in Europe, the UK, Australia, and New Zealand. The information and data for the compilation of the present review has been obtained from the relevant journals and from the official websites of respective drug regulatory authorities of Europe, the UK, Australia, and New Zealand. The generic drug approval process differs from one country to another. Europe follows multiple registration processes and the applicant decides the pathway based on the product category while the other three countries stick to a single registration process. All four countries follow the electronic CTD format for submitting the regulatory documents which allows the evaluation process more convenient and easier. The British Pharmacopoeia is a single reference guide for the quality control of medicines in all four countries under this study. From this study, it was concluded that in Europe and UK it takes about 12 months for dossier review for the approval of the generic drug. TGA of Australia takes approximately 11 months of timeline for generic drug approval whereas; MEDSAFE of New Zealand takes just 200 calendar days for generic drug registration which is quicker as compared to the other three countries.

Keywords: CTD, EMA, MHRA, TGA, MEDSAFE.

Review Article
Previous ArticleConcept of Abdaal e-Advia (Therapeutic Interchange) in the Light of “Maqala Fi- Abdal Al- Adwiya Al- Maustamala Fi -Al -Tib Wa Al- Ilaj” Known as “Kitab Al- Abdal”
Next Article Bridging the Gap: Aligning GMP Requirements for Generic Manufacturing across the US, EU and Japan

Related Posts

Past Work Done on the Matrix Tablets: A Quick Reference for the Research Beginner in Sustained-release Dosage Forms

July 21, 2023

Overview on Evolving Variants of Novel Coronavirus and Control Measures in India

July 21, 2023

An Overview of the Various Appropriate Types of Cell Lines for the Production of Monoclonal Antibodies

July 21, 2023
Download PDF
Cite this Article
Citation Output

Read in Readcube
  • Download PDF
  • ReadCube
Citations & Metrics
Article Metrics
  • Dimensions Metrics
  • Page Views
  • Related
Total Views 0
Last Month Views 0
Click for PLUM.MX Metrics Search this article in Google Scholar Related Articles in Google Scholar Search related in PUBMED


About
About

publishing peer-reviewed scholarly reviews, themed issues and research articles within the entire scope of the Pharmaceutical field. The journal particularly aims to foster the dissemination of scientific information by publishing manuscripts related to Pharmacy and Related Fields.

We're accepting new submissions right now.

Facebook Twitter RSS
Editor Picks

Overview on Evolving Variants of Novel Coronavirus and Control Measures in India

July 5, 2023

An Overview of the Various Appropriate Types of Cell Lines for the Production of Monoclonal Antibodies

July 5, 2023

Ashwagandha: A Flagship Herb of Ayurveda from Past to Present Nano Era

July 5, 2023

Dental Pulp Stem Cells: Biology and Promise for Regenerative Medicine

July 5, 2023
STAY CONNECTED

Contact Editor-In-Chief
Editor, International Journal of Pharm Investigation
#9, Vinnse Tower, Wheeler Road Extn.
St. Thomas Town, 560084, Bangalore, INDIA
Email: editor@jpionline.org

© 2023 Phcog.Net | Published by : EManuscript.
  • Home
  • Submit Article
  • Disclaimer
  • Contact

Type above and press Enter to search. Press Esc to cancel.