Essential medicines and health products

WHO Drug Information

Volume 23, Number 2, 2009

Quality Assurance and Safety of Medicines

WHO Drug Information

Publication details

Number of pages: 108
Languages: English

This issue of the WHO Drug Information opens with an article on the regulatory and safety challenges of approving and monitoring the safety of biosimilar medicines and focuses on major points of the process recently established by the European Union (EU) for approving biosimilars.

A follow-on article discusses the availability, quality and safety of blood and blood products and the necessity of creating sustainable regulated blood and plasma Programmes. For the past 25 years, efforts have focused on improving the safety and efficacy of components derived from blood and plasma, developing and validating new methods, and seeking new therapeutic uses. Transmission of infectious diseases by blood has underscored the importance of quality systems and effective regulation in the preparation of plasma as a raw material for use in the manufacture of medicinal products and supply of other blood components such as platelets and red cells.

A feature article outlines the potential contribution of clinical pharmacologists to government regulatory responsibilities. A clinical pharmacologist can provide the link between government and health care outcomes, serving also as a powerful advocate of evidence-based medicine. They can be invaluable in addressing current challenges such as assessing new medicines, providing unbiased medicines-related information, contributing to treatment guideline development, identifying preventable adverse drug reactions through promoting rational use of medicines and improving prescribing practices

The section on Safety and Efficacy provides information on signals and reports of adverse drug reactions and other safety issues. This is complemented by Regulatory Action and News which gives the latest developments from regulatory authorities.

Corruption in the pharmaceutical sector can take various forms. Whether it is bribery of a government official, falsification of efficacy and safety data, theft in the distribution chain or recruitment of personnel based on favouritism, its impact on public health and government financial resources can no longer be ignored. WHO's recently established Good Governance for Medicines Programme provides readers with its first global report.

Recent Publications, Information and Events indicates recently available source material and training courses.

The journal concludes with Proposed List number 101 of International Nonproprietary Names (INN).