Regulatory Pathways for Vaccines for Developing Countries

By Milstien, Julie; Belgharbi, Lahouari | Bulletin of the World Health Organization, February 2004 | Go to article overview

Regulatory Pathways for Vaccines for Developing Countries


Milstien, Julie, Belgharbi, Lahouari, Bulletin of the World Health Organization


Voir page 132 le resume en francais. En la pagina 133 figura un resumen en espanol.

Background

Vaccine regulation is a complex process, and improvement of national infrastructure in this area has progressed slowly. In 1999, WHO defined six regulatory functions that could be used to assess a NRA, monitor its improvement, and design interventions to impact it (Box 1) (1). This definition is useful in that it provides a transparent basis for assessing regulatory functions, while noting potential differences in data analysis because of differing risk--benefit scenarios (2). In fact, the differing risk-benefit assessment has led to product divergence (3, 4): for example, whole cell versus acellular pertussis vaccine and oral versus inactivated polio vaccine.

Box 1. Six regulatory functions defined by WHO to assess,
monitor, and improve national regulatory authorities

* Published set of requirements for licensing (of products and
manufacturers)

* Surveillance of Vaccine field performance (safety and efficacy)

* System for batch or lot release

* Use of the laboratory when needed

* Regular inspections of manufacturers for good manufacturing
practice compliance

* Evaluation of clinical performance through authorized clinical
trials)

Currently, vaccines are developed and used first in the industrialized world in which the regulatory decisions for these products are taken. New vaccines for the developing world targeted at diseases in developing countries may never be used in the industrialized world. These vaccines need to be under appropriate regulatory control from development to use to ensure they are sale, effective, and of high quality.

NRAs differ with respect to the export and import of vaccines. The US Food and Drug Administration was established by its national government with a mandate to function only for the domestic market. The European Medicines Evaluation Agency operates similarly on behalf of the countries of the European Community but has expressed interest in providing additional regulatory functions for vaccines made in Europe but targeted at developing markets. Many competent NRAs in the developing and industrialized worlds could make decisions on new product licensing, but they would need a new regulatory framework to do so on behalf of other countries in the developing world. Finally, some countries import vaccines only from assured sources, counting on the decisions of other regulatory authorities or the recommendations of WHO, or bath, because they lock the basic infrastructure to make regulatory decisions on their own. As many manufacturers distribute vaccines beyond their borders, the existing regulatory gaps must be addressed, or vaccine supply will be jeopardized.

This paper addresses three types of situations for which regulatory pathways must be assured, given the different national regulatory activities defined above:

1. To ensure that vaccines developed, produced, and licensed in an industrialized country for intended global use are evaluated for their safety and efficacy, not only for the target population in the country of manufacture but also in the target populations of the developing world. This would be the case for an 11-valent pneumococcal conjugate vaccine that could be used in many countries with different disease burdens.

2. To maintain a licence for a product developed, produced, and licensed in an industrialized country when there is no longer a product market in that country. This is the expected situation for combination vaccines based on diphtheria-tetanus-whole cell pertussis (vaccines manufactured and licensed in Europe).

3. To find a pathway to licensure for a product when the market is only in the developing world, regardless of where the product is developed. This could be the case for vaccines against many tropical diseases, such as malaria and leishmaniasis. Lack of a pathway represents "regulatory risk" for potential product developers. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Regulatory Pathways for Vaccines for Developing Countries
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.