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WHO DRUG INFORMATION VOLUME 22 NUMBER 2 2008 PROPOSED INN LIST 99 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION GENEVA WHO Drug Information Vol 22, No. 2, 2008 World Health Organization WHO Drug Information Contents Access to Medicines Lapatinib and hepatoxicity 96 Telbivudine and peripheral neuropathy 96 WHO prequalification: progress in 2007 79 International Nonproprietary Safety and Efficacy Issues Names Update on safety of heparin 84 International Nonproprietary Names Nicorandil-associated ulceration 85 for monoclonal antibodies: IFPMA Topiramate and other drugs causing proposal 97 glaucoma 86 Varenicline: serious psychiatric reactions 86 Montelukast : safety review 88 Regulatory Action and News Neurocognitive effects of chemotherapy 89 Dydrogesterone withdrawn for New MMRV vaccine recommendations 89 commercial reasons 108 Oseltamivir label updated with neuro- Enoxaparin contamination: batches psychiatric warning 90 recalled 109 Ketoconazole tablets: risk of hepato- Recombinant antihemophilic factor toxicity 90 approved 110 Alemtuzumab: infection-related deaths 91 Rotavirus vaccine approved 111 Mycophenolate mofetil: progressive New version of genetically engineered multifocal leukoencephalopathy 91 Factor VIIa approved 111 Modafinil: serious rash and psychiatric symptoms 92 Moxifloxacin: serious hepatic and skin International Pharmacopoeia reactions 92 Role of The International Pharmacopoeia Rimonabant: depression; psychiatric in quality assurance 113 reactions 93 Exenatide: risk of acute pancreatitis 94 Zanamivir: neuropsychiatric events 94 Proposed International Inosine ponophosphate dehydrogenase Nonproprietary Names: inhibitors: congenital anomalies 94 Strontium ranelate : life-threatening List 99 121 allergic reactions 95 77 WHO Drug Information Vol 22, No. 2, 2008 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 (PDF) of the latest WHO Drug Information To subscribe: send a message to [email protected] containing the text: subscribe druginformation 78 WHO Drug Information Vol 22, No. 2, 2008 Access to Medicines WHO prequalification: products. This offers a considerable increase in the choice of prequalified progress in 2007 medicines for these diseases. The Prequalification Programme for The total number of prequalified products medicinal products is a service provided in 2007 was the lowest since 2001. The by the World Health Organization (WHO) main reasons for this are: to facilitate access to medicines that meet international unified standards of quality, • decreasing number of new submissions; safety and efficacy for HIV/AIDS, malaria, tuberculosis and reproductive health. • submitted dossiers did not include sufficient evidence to prove quality, Work is carried out through: safety and efficacy of products; and • stringent assessment of pharmaceutical • little additional substantive evidence product dossiers; was provided in support of dossiers previously submitted. • inspection of pharmaceutical manufac- turing sites (both for finished dosage Certain product groups are urgently in forms and active pharmaceutical ingre- need of expansion to increase available dients) and contract research organiza- treatment options, i.e., second-line anti- tions (CROs); tuberculosis and paediatric antiretroviral combination products. In 2007, only one • prequalification of pharmaceutical antituberculosis treatment submission quality control laboratories (QCLs); and and two new submissions for paediatric • advocacy for medicines of assured antiretrovirals were presented for WHO quality. Prequalification. The Programme also provides high-level In the past year, the number and quality training, capacity building and technical of product dossiers submitted for assess- assistance to stakeholders from both the ment was very uneven. Conversely, a private and public sectors. The Bill & considerable number of new applicants Melinda Gates Foundation as well as approached WHO. However, most of the UNITAID are currently the principle newcomers have limited or no experience financial supporters of the WHO Prequali- in production to international standards fication Programme. and are not yet capable of generating the required evidence. The manufacturing New prequalified products conditions and quality specifications presented for reproductive health and Twenty-one products were added to the list antimalarial products were particularly of prequalified medicines in 2007 – all but poor. one being generics. The number of pre- qualified medicines now stands at 156. Efforts needed to reach A major achievement in 2007 was the prequalification status prequalification of five new products to The products prequalified in 2007 were, treat tuberculosis and three antimalaria on average, under assessment and 79 Access to Medicines WHO Drug Information Vol 22, No. 2, 2008 Summary of activities in 2007 The WHO Prequalification Programme: • Prequalified a total of 21 medicinal products, including 5 anti-tuberculosis and 3 anti-malarial medicines • Intensified and widened the scope of prequalification of quality control laborato- ries • Doubled the number of training workshops for capacity building in resource- limited countries • Organized 10 technical assistance missions for manufacturers to support im- provements in the quality of their products • Planned and implemented a comprehensive sampling and testing programme • Developed guidelines and standards to facilitate global quality assurance activi- ties, including pharmacopoeial monographs and chemical reference substances • Undertook special efforts to facilitate development of paediatric formulations • Recruited additional full-time staff to maintain sustainability and improve perform- ances of prequalification process • Streamlined the process between receiving a complete dossier and the first assessment or inspection of manufacturing sites • Developed tools to increase transparency and allow monitoring of the prequalifi- cation process adjustment for two years before attaining Maintaining the list compliance with international standards. of prequalified medicines During this period, eight to nine assess- Inclusion in the list does not mean that ment sessions and five inspections were the prequalified status of a product lasts required before the ultimate positive forever. All prequalified medicines have conclusions were reached. Thus, consid- to be checked regularly in order to ensure erable time and resources are needed that any changes undertaken by manu- from applicants, as well as dedication to facturers do not undermine the quality, implementing the necessary corrective safety and efficacy of the products. action, to meet international quality standards. In order to reach this objective, WHO assesses variations in manufacture and All involved stakeholders agree and carries out random quality control tests of understand that expansion of the list of prequalified medicines, as well as re- prequalified medicines can only be inspections of manufacturing sites. As the realized if capacity building and technical prequalified products list is constantly assistance activities increase in resource- growing, maintaining and updating the limited countries. Therefore, such actions information becomes increasingly impor- have become one of the core objectives tant in order to ensure the quality and of the Prequalification Programme. safety of the medicines. 80 WHO Drug Information Vol 22, No. 2, 2008 Access to Medicines Training Workshops organized in 2007 Date Location Content of training 16–20 April Cape Town, Pharmaceutical development with a South Africa focus on paediatric medicines 6–7 June Cairo, Egypt WHO Prequalification Programme – introduction for EMRO countries 25–27 June Kiev, Ukraine Dissolution, pharmaceutical product inter-changeability and biopharma- ceuticals classification system 10–14 September Dar Es Sallam, Assessment of dossiers based on Tanzania WHO Prequalification guidelines for staff of East Africa Community national medicine regulatory authorities 15–19 October Tallinn, Estonia Pharmaceutical development with a focus on paediatric medicines 5–9 November Jiaxing, China Pharmaceutical quality, Good Manufac turing Practice and bioequivalence with a focus on anti-tuberculosis products 26–29 November Rabat, Morocco Quality assurance, Prequalification and quality control in quality control laboratories 10–14 December Dakar, Senegal Good Manufacturing Practice training course for countries of francophone Africa 5–7 December Dar Es Sallam, Quality assurance, Prequalification and Tanzania development of standards in quality control laboratories Capacty building groups, including staff from regulatory for regulatory authorities agencies and quality control laboratories, Recognizing the importance of capacity and for manufacturers. Such training building through training and hands-on includes group sessions as well as practice, the WHO Prequalification communication between involved parties, programme organized nine training such as manufacturers and the present- courses in 2007 and co-organized four ers, who are themselves part of the training activities together with other assessment or inspection teams working partners in nine different countries. with the Prequalification Programme. These exercises offered tuition on gen- In 2007, four national
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