Model web site for medicines regulatory authorities
Purpose
The WHO DRA model web site is seen as a potential tool to help fight inappropriate use of the Internet, both for distribution of biased and dangerous drug information and unlawful sale of products via the Internet.
The model web site wishes to provide criteria and guidance for existing or new national DRA web sites addressing the following concerns:
- quality of pharmaceutical information available on the Internet
- purchase of drugs through the Internet
- global availability of the latest medical information
- professional advice on pharmaceuticals
The model web site identifies the minimum quantity of information a new national DRA should have on its web site, especially drug information that has been approved by new the DRAs. Different types of drug information, including lists of approved drugs, national drug regulations, information on how to ensure safe, efficacious and rational use of specific drugs, lists of approved companies and their authorized activities, details of persons and institutions with responsibility for drug regulation is of utmost importance to those working in the pharmaceutical sector, to health care professionals, procurement services and to the general public.
What are the problems currently encountered?
Good quality drug regulatory information can be difficult to find. A recent WHO survey showed that although some new national DRAs maintain web sites, most of these do not post comprehensive drug information, and very few provide access to drug marketing authorizations or approved drug information.
Lacking good quality drug information, health care providers and consumers may be uncertain as to which drugs meet national regulations and have been approved and which drugs may be imported. For consumers, these problems are being exacerbated by the growth in pharmaceutical e-trade, which is unregulated and uncontrolled. Ensuring rational use of drugs and efficient drug supply then becomes more difficult. At the same time, lack of drug information can suggest that new national DRAs are not “transparent”, ultimately leading to poor trust in the quality and legitimacy of their work.
How does WHO want to solve these problems?
For a start, drug regulatory information has to be made more widely available and more easily accessible. The Internet is a powerful information tool that can be used for this purpose. It can be a source of valuable, good quality information on the approved drugs available on different national markets.
For many new national DRAs, this will mean creating a web site. For others, the task will be to improve an existing web site.
To speed up the process, WHO is proposing this model web site to guide new national DRAs in creating user-friendly web-sites for health professionals, consumers/patients, other DRAs and industry.
How will we do it?
WHO has begun developing this model web site for new national DRAs in close collaboration with a selected group of WHO Member states; the model web site will then be field-tested for countries. Following field-testing and finalization of the model web site, supporting user manuals would be prepared.
The model web site includes a tool for importing data from the WHO Model System for Computer-assisted Registration (known as SIAMED) and other databases. SIAMED is used by many DRAs worldwide for ensuring that marketing authorizations are consistent with national drug policies.
A tool for requesting/downloading the WHO Type Certificate for Pharmaceutical Products Moving in International commerce will also be created.
What impact do we expect from the model web site?
By making pharmaceutical information available on reliable, accessible web sites, DRAs will greatly speed up the work of health professionals involved in drug procurement and supply. Better prescribing by medical doctors will also be facilitated and rational use of drugs improved. Just as important, communication and transparent dialogue among national DRAs, industry, consumers/patients and health professionals will be enhanced.
More generally, national DRAs will:
- increase the transparency of their own activities
- improve collaboration between DRAs, health professionals and academics
- improve the public health impact of drug regulatory work
- facilitate networking between DRAs to solve drug regulation problems
- offer reliable and unbiased drug information to guide Internet users.
This will also help to combat substandard and counterfeit drugs since increased availability of good quality drug regulatory information will enable quick verification of product registration status in various countries and help alert drug regulators and health care providers as regards misuse and irregularities.