- Tous > Medicine Information and Evidence for Policy > Information and Publications
- Tous > Quality and Safety: Medicines > Blood Products and Related Biologicals
- Tous > Quality and Safety: Medicines > Counterfeit Medicines
- Tous > Quality and Safety: Medicines > International Nonproprietary Names
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Tous > Quality and Safety: Medicines > The International Pharmacopoeia
- Tous > Prequalification of Medicines > WHO-UNICEF-UN Project
- Mots-clés > access - blood products
- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > counterfeiting - measures to combat
- Mots-clés > harmonization of medicines regulation
- Mots-clés > medicines registration
- Mots-clés > Prequalification of diagnostics, medicines and vaccines - WHO
- Mots-clés > registration - Accelerated Registration Pilot Project
- Mots-clés > safety and efficacy
- Mots-clés > substandard/spurious/falsely-labelled/falsified/counterfeit medicines
(2013; 93 pages)
The first issue for 2013 opens with a feature article on access to safe and effective blood products in low and middle income countries and the initiative to recognize blood products as essential medicines. Blood products include blood and blood components produced as single-donor products for direct transfusion (red blood cells, platelets and plasma) as well as numerous plasma-derived medicinal products (albumin, polyvalent and specific immunoglobulins and blood coagulation factors) that are prepared in fractionation facilities from pools of thousands of plasma units. Unfortunately, a recent meeting report has highlighted the large amount of wastage of separated plasma because infrastructure for further manufacture is often lacking in low and middle income countries.
The Current Topics section presents an update on four initiatives. The first concerns the Member State Mechanism on Substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) Medical Products which was established in May 2011 by the World Health Assembly to promote international collaboration on strategies and address the falsification of medicines from the standpoint of public health, excluding trade and intellectual property considerations. The second item describes the Accelerated Registration Pilot Project which is a new collaborative activity between medicines regulators in developing countries and international experts working with WHO’s Prequalification of Medicines Programme. This encourages national regulatory authorities to fast track the registration of medicines that have already been assessed and approved by WHO’s prequalification procedure. The third describes the Programme for Promoting the Quality of Medicines which is funded by the US Agency for International Development and implemented by the US Pharmacopeial Convention. Its aim is to increase the availability of affordable, high-quality medicines to treat patients worldwide suffering from multidrug-resistant tuberculosis by providing technical assistance at no cost to manufacturers. A final short summary provides feedback from the latest meeting in Nanchang, China, of the International Generic Drug Regulator’s Pilot Project created to promote regulatory collaboration and convergence in generic drug regulatory programmes and address challenges posed by increasingly heavy workloads, globalization, and the growing complexity of scientific issues.
The section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling changes. This is complemented by the section on Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-making and risk assessment.
Recent Publications, Information and Events, provides brief summaries of several recently-published documents and online resources.
The journal concludes with the 69th Recommended List of International Nonproprietary Names (INN).