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WHO Drug Information Vol 23, No WHO Drug Information Vol 23, No. 1, 2009 World Health Organization WHO Drug Information Contents Quality of Medicines Erlotinib: Use in hepatic impairment and advanced solid tumours 32 WHO medicines prequalification: Generic piperacillin and tazobactam: progress in 2008 3 medication errors 33 Safety of artemisinin combination therapy: Herbal and Traditional pregnant women 33 Medicines WHO Congress on Traditional Medicine Regulatory Action and News and the Beijing Declaration 8 Efalizumab: suspension of marketing authorization 35 Contusugene ladenovec: withdrawal of Biomedicines Update marketing application 36 Global norms and standards for biological Paliperidone: withdrawal of application quality, safety and efficacy 12 for extension of indication 36 First EMEA meeting of Committee for Safety of Medicines Advanced Therapies 36 The mobile laboratory: a new concept in medicines surveillance 16 Consultation document International Pharmacopoeia Pharmacovigilance Focus Oxytocin 38 Oxytocin injection 43 Monitoring the safety of off-label medicine use 21 Drotrecogin alfa: what relation to Recent Publications, thrombosis? 22 Information and Events Low availability, high prices keep Safety and Efficacy Issues essential medicines out of reach 46 Genetic basis of adverse drug events 26 Sources and prices of selected Anaesthetic infusion with pain pumps: medicines for children 46 articular chondrolysis 26 Two international summer courses Atomoxetine: serious liver injury 27 in the Netherlands 47 Drotrecogin alfa: ongoing safety review 28 Global politics of pharmaceutical Clopidogrel bisulfate: ongoing safety monopoly 48 review 29 Modafinil: adverse skin and psychiatric reactions 30 Recommended International Levothyroxine update 30 Nonproprietary Names: Temsirolimus: hypersensitivity reactions 31 List 61 Continued vaccination with Gardasil® 32 49 1 World Health Organization WHO Drug Information Vol 23, No. 1, 2009 WHO Drug Information is also available online at http://www.who.int/druginformation NEW ! WHO Drug Information DIGITAL LIBRARY with search facility at http://www.who.int/druginformation Subscribe to our e-mail service and receive the table of contents of the latest WHO Drug Information (To subscribe: send a message to [email protected] containing the text: subscribe druginformation) 2 WHO Drug Information Vol 23, No. 1, 2009 Quality of Medicines WHO medicines prequalification: progress in 2008 The WHO Prequalification Programme for considerable breakthrough in making Medicines (PQP) was initiated in 2001 as user-friendly formulations available that a service provided by the World Health will also improve efficacy of treatment. Organization (WHO) to facilitate access to medicines that meet unified interna- The number of products prequalified in tional standards of quality, safety and 2008 was the highest in six years. The efficacy for HIV/AIDS, malaria, tuberculo- main reasons for this were: sis and reproductive health. • Increasing number of well prepared new The work is carried out through: submissions in 2007–2008. • Stringent assessment of pharmaceutical • Improved quality of evidence to demon- product dossiers. strate quality, safety and efficacy of products. • Inspection of pharmaceutical manufac- turing sites (both for finished dosage • Expanded staffing component in 2007. forms and active pharmaceutical ingre- • Implementation of management effi- dients) and contract research organiza- ciency tools which improve the evalua- tions (CROs). tion process. • Prequalification of pharmaceutical quality control laboratories (QCLs). List of prequalified medicines Inclusion in the list does not mean that • Advocacy for medicines of assured the prequalification status of a product is quality. assured indefinitely. All approved medi- cines have to be checked regularly to The Bill & Melinda Gates Foundation as ensure that any changes undertaken by well as UNITAID are the main financial manufacturers do not undermine the supporters of PQP. quality, safety and efficacy of the product. Newly prequalified medicines In order to achieve this objective, WHO Forty products were added to the list of carries out re-inspections of manufactur- prequalified medicines in 2008, an ing sites as well as random quality control increase from 21 products in 2007. The tests of prequalified medicines. Since the total number of prequalified medicines prequalified products list is constantly currently stands at 196. being added to, information maintenance and updating becomes crucial to the A major achievement in 2008 was the preservation of established international prequalification of new products specially standards. designed to treat HIV/AIDS in children, as well as the first fixed-dose combination New submissions to PQP tablets of artesunate and amodiaquine to Certain product groups are urgently in treat malaria. These products represent a need of expansion to increase available 3 Quality of Medicines WHO Drug Information Vol 23, No. 1, 2009 In 2008, the WHO Medicines Prequalification Programme: • Prequalified a total of 40 medicinal products. The list of prequalified medicines now contains nearly 200 products. • Prequalified the first ever fixed-dose combination tablets of antiretroviral medi- cines designed for use in children to treat HIV/AIDS, and the first fixed-dose combination tablets of artesunate and amodiaquine to treat malaria. • Organized 11 training workshops for capacity building in resource-limited coun- tries for staff of regulatory authorities and pharmaceutical manufacturers. • Provided manufacturers with scientific advice and technical assistance to sup- port improvements in the quality of their products. • Implemented the biowaiver concept to facilitate evaluation of product dossiers. • Prequalified six quality control laboratories. • Planned and implemented three comprehensive medicines sampling and testing programmes in countries that were recipients of drug donations. • Revised and updated the procedure for prequalification to increase transparency and accountability of prequalification performance. • Contributed to the development of guidelines and standards to facilitate global quality assurance activities, including pharmacopoeial monographs and chemi- cal reference standards. • Opened prequalification to include zinc and influenza products and considerably expanded the invitation list of reproductive health products. treatment options (e.g., second-line required. Insufficient quality specifications antituberculosis and paediatric antiretrovi- presented for reproductive health and ral combination products). However, it antimalarial products and manufacturing was again noted that the number of conditions are of particular concern. products submitted for evaluation within this category was insufficient to meet In recent years, documented quality current demand. This is mainly due to a assurance of medicines has become an lack of commercial incentives available to essential requirement of international manufacturers to develop products funding agencies for successful bidding in intended for small or non-profitable procuring essential medicines for devel- markets. oping countries. Manufacturers should therefore be increasingly motivated to In the past year, the number and quality invest in enhancing their own manufactur- of product dossiers submitted for assess- ing and control processes to improve the ment continued to present many chal- quality of submissions to the PQP. lenges. Newcomer manufacturers having limited or no experience in production Technical assistance to manufacturers according to international standards have Time and resources are needed from great difficulty in submitting the evidence applicants to obtain product prequalifica- 4 WHO Drug Information Vol 23, No. 1, 2009 Quality of Medicines tion and this includes dedication to Capacity building of implementation of corrective action to regulatory authorities meet international quality standards. It In 2008, the PQP continued to offer follows that an increase in the number of national regulatory personnel from available prequalified medicines can only resource-limited countries a three-month be achieved based on increased capacity full-time post at WHO. These rotational building and technical assistance activi- positions for quality assessors are aimed ties. at creating links and form a network between WHO and the countries in- Consequently, since 2006, the PQP has volved, as well as enhance information provided coordinated technical assistance exchange between both parties. aimed at resolving specific practical problems encountered by manufacturers In addition, assessors from less re- or quality control laboratories. Assistance sourced regulatory authorities continue to is provided by qualified professionals in participate in PQP assessment sessions the form of an audit and training in where they account for one-third of the technical or regulatory areas. total external assessor contribution. Since 2008, inspectors from these Such action in resource-limited countries authorities are invited to take part in has become one of the core activities of WHO inspections as observers. Regula- PQP since 2007 and will remain so for tors from the WHO Africa Region have the following years. In 2008, PQP pro- been especially active in this process. vided eight technical assistance missions to pharmaceutical manufacturers in five Dossier assessments different countries. and expert advice In 2008, seven assessment sessions Training were organized at the UNICEF Supply WHO
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