IDEAS home Printed from https://ideas.repec.org/a/spr/aphecp/v13y2015i1p5-11.html
   My bibliography  Save this article

Definition and Classification of Generic Drugs Across the World

Author

Listed:
  • Rafael Alfonso-Cristancho
  • Tatiana Andia
  • Tatiana Barbosa
  • Jonathan Watanabe

Abstract

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30 % of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable. Copyright The Author(s) 2015

Suggested Citation

  • Rafael Alfonso-Cristancho & Tatiana Andia & Tatiana Barbosa & Jonathan Watanabe, 2015. "Definition and Classification of Generic Drugs Across the World," Applied Health Economics and Health Policy, Springer, vol. 13(1), pages 5-11, August.
  • Handle: RePEc:spr:aphecp:v:13:y:2015:i:1:p:5-11
    DOI: 10.1007/s40258-014-0146-1
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1007/s40258-014-0146-1
    Download Restriction: Access to full text is restricted to subscribers.

    File URL: https://libkey.io/10.1007/s40258-014-0146-1?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Andreas Seiter, 2010. "A Practical Approach to Pharmaceutical Policy," World Bank Publications - Books, The World Bank Group, number 2468.
    2. Bate, Roger & Jin, Ginger Zhe & Mathur, Aparna, 2011. "Does price reveal poor-quality drugs? Evidence from 17 countries," Journal of Health Economics, Elsevier, vol. 30(6), pages 1150-1163.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Thakur–Wernz, Pooja & Wernz, Christian, 2022. "Impact of stronger intellectual property rights regime on innovation: Evidence from de alio versus de novo Indian bio-pharmaceutical firms," Journal of Business Research, Elsevier, vol. 138(C), pages 457-473.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Roger Bate & Ginger Zhe Jin & Aparna Mathur & Amir Attaran, 2014. "Poor Quality Drugs and Global Trade: A Pilot Study," NBER Working Papers 20469, National Bureau of Economic Research, Inc.
    2. Roger Bate & Ginger Zhe Jin & Aparna Mathur, 2012. "In Whom We Trust: The Role of Certification Agencies in Online Drug Markets," NBER Working Papers 17955, National Bureau of Economic Research, Inc.
    3. Esther Atukunda & Anne Fitzpatrick, 2015. "An Evaluation of Factors Affecting Drug Quality: Evidence from the Antimalarial Market in Uganda," Working Papers 2015_03, University of Massachusetts Boston, Economics Department.
    4. Nicholas Wilson, 2015. "Can Disease-Specific Funding Harm Health? in the Shadow of HIV/AIDS Service Expansion," Demography, Springer;Population Association of America (PAA), vol. 52(5), pages 1671-1700, October.
    5. Daniel Bennett & Wesley Yin, 2014. "The Market for High-Quality Medicine," NBER Working Papers 20091, National Bureau of Economic Research, Inc.
    6. Roger Bate & Ginger Zhe Jin & Aparna Mathur, 2012. "Counterfeit or Substandard? Assessing Price and Non-Price Signals of Drug Quality," NBER Working Papers 18073, National Bureau of Economic Research, Inc.
    7. Lin, Yu-Shiuan & Lin, Min-Ting & Cheng, Shou-Hsia, 2019. "Drug price, dosage and safety: Real-world evidence of oral hypoglycemic agents," Health Policy, Elsevier, vol. 123(12), pages 1221-1229.
    8. World Bank, 2017. "Georgia Public Expenditure Review," World Bank Publications - Reports 27138, The World Bank Group.
    9. Fitzpatrick, Anne, 2023. "Which price is right? A comparison of three standard approaches to measuring prices," Journal of Development Economics, Elsevier, vol. 163(C).
    10. Dai, Rong & Watal, Jayashree, 2021. "Product patents and access to innovative medicines," Social Science & Medicine, Elsevier, vol. 291(C).
    11. Afschin Gandjour, 2013. "Reference Pricing and Price Negotiations for Innovative New Drugs," PharmacoEconomics, Springer, vol. 31(1), pages 11-14, January.
    12. Steve Morgan & Jamie R. Daw & Michael R. Law, 2013. "Rethinking Pharmacare in Canada," C.D. Howe Institute Commentary, C.D. Howe Institute, issue 384, June.
    13. Levaggi, Rosella & Marcantoni, Claudio & Filippucci, Laura & Gelatti, Umberto, 2012. "Not a good buy: Value for money of prescription drugs sold on the Internet," Health Policy, Elsevier, vol. 106(3), pages 241-245.
    14. Samuel Yaw Akomea & Olav Jull Sørensen & Kweku Amponsah-Efah, 2014. "Export Drivers And Barriers: Evidence From Ghanaian Pharmaceutical Manufacturing Firms," Global Journal of Business Research, The Institute for Business and Finance Research, vol. 8(2), pages 81-96.
    15. Srivastava, Divya & McGuire, Alistair, 2013. "Analysis of prices paid by low-income countries - how price sensitive is government demand for medicines?," LSE Research Online Documents on Economics 54487, London School of Economics and Political Science, LSE Library.
    16. Soppi, Aarni & Heino, Pekka & Kurko, Terhi & Maljanen, Timo & Saastamoinen, Leena & Aaltonen, Katri, 2018. "Growth of diabetes drug expenditure decomposed—A nationwide analysis," Health Policy, Elsevier, vol. 122(12), pages 1326-1332.
    17. Adrienne M. Lucas & Nicholas L. Wilson, 2018. "Can At-Scale Drug Provision Improve the Health of the Targeted in Sub-Saharan Africa?," American Journal of Health Economics, University of Chicago Press, vol. 4(3), pages 358-382, Summer.
    18. Srivastava, Divya & McGuire, Alistair, 2015. "Patient access to health care and medicines across low-income countries," Social Science & Medicine, Elsevier, vol. 133(C), pages 21-27.
    19. Barenji, Reza Vatankhah & Hariry, Reza Ebrahimi & Demirkol, Denizhan & Daim, Tugrul U., 2024. "Research landscape analysis for quality in Pharma 4.0 era," Technology in Society, Elsevier, vol. 76(C).
    20. Bonny Parkinson & Catherine Sermet & Fiona Clement & Steffan Crausaz & Brian Godman & Sarah Garner & Moni Choudhury & Sallie-Anne Pearson & Rosalie Viney & Ruth Lopert & Adam Elshaug, 2015. "Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review," PharmacoEconomics, Springer, vol. 33(9), pages 905-924, September.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:aphecp:v:13:y:2015:i:1:p:5-11. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.