Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
About us

WHO Medical Product Alerts – Background

pms_home280px

Objective

To ensure a timely, proportionate, accurate and consistent response to health events arising from SF medical products which represent a significant threat to International public health

Criteria

WHO will take the following criteria into account before issuing a Medical Product Rapid Alert:

  • Has the report been validated (e.g. through laboratory analysis)?
  • Does a genuine and significant threat to public health exist?
  • Does the risk extend beyond the country where the product was first discovered?
  • Have any warnings or alerts already been issued concerning the SF medical product and if so when and where?
  • Have adequate steps been taken to remove the product from the supply chain?
  • Is the report recent or is it likely the SF product remains in circulation?

 

Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The prompt reporting of adverse reactions can lead to the early identification of SF medical products. 10% of SF medical products reported to the Global Surveillance and Monitoring System are associated with a toxic reaction in patients. This ranges in severity from a rash on the skin through to hospitalizations and fatalities.

However 90% of SF medical products reported do not cause a toxic reaction in the patient, but do fail to treat the disease or condition for which they are intended. These cases are very difficult to identify and can lead to serious consequences for patients who believe they are treating their condition when they are not.

Increasing pharmacovigilance reporting by healthcare professionals and patients and raising awareness concerning the importance of reporting an unusual lack of efficacy of a medical product is an important component in identifying SF medical products that have reached consumers.

Reporting

Some countries have put in place patient reporting systems, telephone hotlines and web based reporting systems all of which can assist in identifying SF medical products. Some of the most serious cases reported to WHO by National Regulatory authorities have originated from patients, nurses and pharmacists.

Market Surveys

Regular sampling and surveying of both the regulated and unregulated supply chains is a way of identifying SF medical products.

Different methodologies are used to sample the market and range from random sampling through to targeted sampling of particular products and outlets.

The WHO are currently consulting on recommendations on the content of a survey protocol for surveys of the quality of medicines.

Surveying is another important tool in assessing access to quality, safe and efficacious medical products.