WHO Quality Assurance and Safety

The Quality Assurance and Safety: Medicines team is responsible for providing guidance and support to countries on drug safety matters. The team is part of the Department of Essential Drugs and Medicines Policy, within the WHO Health Technology and Pharmaceuticals cluster. The purpose of the department is:
to help save lives and improve health by closing the huge gap between the potential that essential drugs have to offer and the reality that for millions of people – particularly the poor and disadvantaged – medicines are unavailable, unaffordable, unsafe or improperly used.

WHO works towards fulfilling this mission by providing global guidance on essential drugs and medicines, and working with countries to implement national drug policies.These are designed to ensure:

• equity of access to essential drugs
• drug quality and safety
• rational use of drugs.

The explicit objectives of the Quality Assurance and Safety: Medicines team are:
• to ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards.

For this policy to meets its objectives, the scope of pharmacovigilance needs to be extended to include the safety of all related health technologies, including medicines, vaccines, blood products, biotechnology, herbal medicines and traditional medicines.

Functions of the WHO Programme for International Drug Monitoring include: • Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centres, and from them to the WHO database. A data-mining approach (BCPNN) is used at the UMC to support the clinical analysis made by a panel of signal reviewers.
Provision of the WHO database as a reference source for signal strengthening and ad hoc investigations. Web-based search facilities and customized services are available • Information exchange between WHO and National Centres, mainly through 'Vigiflow', an e-mail information exchange system • Publication of periodical newsletters , (WHO Pharmaceuticals Newsletter and Uppsala Reports), guidelines and books in the pharmacovigilance and risk management area • Supply of tools for management of clinical information including adverse drug reaction case reports. The main products are the WHO Drug Dictionary and the WHO Adverse Reaction Terminology • Provision of training and consultancy support to National Centres and countries establishing pharmacovigilance systems • Computer software for case report management designed to suit the needs of National Centres (VigiFlow) • Annual meetings for representatives of National Centres at which scientific and organizational matters are discussed • Methodological research for the development of pharmacovigilance as a science.