Regulatory Implementation Working Group

Counterfeit medical products pose a significant danger to public health in developing as well as developed countries. Counterfeits may be distributed through different distribution channels such as governmental health systems, hospitals, pharmacies, other legitimate or illegitimate distributors, as well as sold over the internet.

Because counterfeiters are good at what they do, licensed distributors, pharmacists, health care providers or patients are sometimes unable to detect or differentiate between counterfeit and genuine medical products. It has been difficult to assess the extent of the problem of counterfeit medical products around the world. Reasons being among others; lack of resources/skills to detect counterfeit medical products, absence or weak regulatory and enforcement systems, different definitions of counterfeit medical products in different countries worldwide, as well as variation in distribution systems. As a result, estimates on the actual extent of the problem may be incomplete and vary from country to country.

The Regulatory Implementation Working Group aims to:

  • promote implementation of Good Manufacturing, Good Distribution and Good Pharmacy Practice guidelines and quality assurance systems to ensure supply chain integrity;
  • develop model training materials aimed at improving quality assurance within and supervision of distribution chain;
  • develop guidance on the role of quality control laboratories in combating counterfeit drugs;
  • develop data collection tools and methodologies to assess national regulatory and enforcement systems in order to identify gaps and measures needed;
  • at the request of national authorities develop ad hoc projects to improve capacity to combat counterfeit medicines;
  • promote secure exchange of information and alerts among regulatory and/or enforcement officials as appropriate
  • promote networking and collaboration among national drug regulatory authorities
  • develop guidance for pharmacovigilance systems to include reporting and investigating suspected cases of counterfeit medicines
Resources
For comments

The "PROPOSAL FOR REVISION OF THE WHO GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS" was submitted to the 44th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations held 12-16 October 2009. The committee members reviewed all comments received to this proposal during the wide consultation process and adopted a revised version as Annex 5 to their report. This report is currently in print and will soon be available as WHO Technical Report Series No 957.
For more information please see the following web site:
:: http://www.who.int/medicines/services/expertcommittees/pharmprep/en/index.html

Useful links
Share

Contact details

Chair Regulatory Implementation Working Group:
Dr Ilisa Bernstein,
Director, Pharmacy Affairs,
Food and Drug Administration, USA