WHO Drug Information Vol. 24, No. 2, 2010 World Health Organization WHO Drug Information Contents WHO Prequalification Regulatory Action and News Programmes Ceftobiprole medocaril: discontinuation WHO Prequalification of diagnostics, of sale 111 medicines and vaccines 83 Bufexamac : revocation of marketing WHO Prequalfication of Medicines authorization 111 Programme: Inspection of finished Rosiglitazone: authorization suspended 111 pharmaceutical product manufacturers 87 Sitimagene ceradenovec: withdrawal of marketing authorization application 112 Albinterferon alfa-2b: withdrawal of Regulatory Harmonization marketing authorization application 112 Optimization of medicines regulatory Docetaxel: withdrawal of marketing authority web sites 91 authorization application 112 Rotarix® oral vaccine: new information 113 Essential Medicines Paediatric Medicines Regulators Network113 Regulatory action needed to stop the sale of oral artemisinin-based Consultation Document monotherapy 98 The International Pharmacopoeia Emtricitabine and tenofovir tablets 115 Safety and Efficacy Issues Sulfadoxine and pyrimethamine Leflunomide and peripheral neuropathy 105 tablets 118 Saquinavir mesylate: prolongation of QT and PR intervals 106 Recent Publications, Human immune globulin: intravascular Information and Events haemolysis 106 Life-saving antivenoms: guidelines Irinotecan-induced severe neutropenia: and database 123 UGT1A1 variant alleles 107 Sources of paediatric medicines 123 Combination of niacin/laropiprant and Multidrug and drug-resistant tuberculosis123 simvastatin: myopathy 108 Guidelines for the treatment of malaria 124 Entacapone/carbidopa/levodopa: Where there are no pharmacists 124 prostate cancer 109 Becaplermin contraindicated in cancer patients 109 Proposed International Panitumumab: hypersensitivity reactions 110 Nonproprietary Names List 103 125 81 World Health Organization WHO Drug Information Vol. 24, No. 2, 2010 Announcement The 14th International Conference of Drug Regulatory Authorities (ICDRA) will be hosted by the Health Sciences Authority, Singapore, in collaboration with the World Health Organization The ICDRA will take place in Singapore from 30 November to 3 December 2010 Updated information is available at: http://www.icdra2010.sg http://www.who.int/medicines/icdra 82 WHO Drug Information Vol. 24, No. 2, 2010 WHO Prequalification Programmes WHO Prequalification of international, harmonized quality and safety standards and seeks to ensure that diagnostics, medicines other agencies and organizations pro- and vaccines mote and adhere to these standards. The Programme is also working with United World Health Organization (WHO) pre- Nations (UN) partners and procurement qualification is a highly visible service organizations to harmonize procurement having an immediate impact for countries. requirements for diagnostics. In areas WHO prequalification programmes for where no prequalified products yet exist, diagnostics, medicines and vaccines it advises on purchase of non-prequalified operate on similar principles and offer a products. valuable assurance of quality. Each programme regularly conducts technical Capacity building and performance reviews to identify The WHO Programme for Diagnostics potential gains in efficiency. Prequalification is working with Burkina Faso, Côte d’Ivoire, South Africa and Diagnostics Tanzania to strengthen implementation of regulations concerning registration and In recent years, the number of diagnostic licensing of diagnostics and to establish products for priority diseases such as systems for postmarketing surveillance. HIV, TB and malaria has increased. Of (Activities will be extended to China WHO’s 193 Member States, fewer than during 2010.) one-third have a regulatory system in place and even where regulations for Guidance documents highlighting require- diagnostics exist, they are often not ments for inspections and quality man- enforced. agement systems are being finalized for use by manufacturers seeking to obtain Approximately 85% of applications WHO prequalification. submitted to the WHO Programme for Diagnostics Prequalification are for Cost effectiveness products made in less stringently regu- Prequalification of diagnostics stimulates lated countries, particularly in Asia. innovation and helps create a secure Moreover, as the target markets for these market for good-quality, safe and appro- diagnostics are resource-limited coun- priate diagnostics that would otherwise tries, the manufacturers concerned do not not be accessible. For example, prequali- consider that they need to obtain licens- fication of diagnostics stimulates develop- ing from a stringent regulatory authority. ment of technologies such as rapid tests, The Programme targets its assessment appropriate for use at primary health care efforts at such products, paying particular level and by non-lab technicians (which attention to appropriateness for use in promotes task shifting). During the past resource-limited settings and advocating four years, the UN and Global Fund to for the development of innovative diag- Fight AIDS, Tuberculosis and Malaria nostics for such settings. (GFATM) procurement of HIV and malaria The WHO Programme for Diagnostics rapid tests has ranged between 10 and Prequalification bases its activities on 18 million tests annually. 83 WHO Prequalification Programmes WHO Drug Information Vol. 24, No. 2, 2010 WHO facilitates access to safe, appropri- international, harmonized quality and ate diagnostics of good quality at reduced safety standards. This includes working cost, saving money that can be used to with the GFATM and procurement organi- purchase additional diagnostics or in- zations to harmonize procurement and vested in other health care interventions. quality assurance requirements. In areas In the USA, for example, a rapid HIV test for which no prequalified product yet costs around ten US dollars, while the exists, and on behalf of UN partners, the UN/WHO price is around one US dollar. WHO Prequalification of Medicines Savings are also generated since health Programme organizes, upon request, care costs associated with poor-quality expert assessment reviews to advise on diagnostics are reduced. Additionally, the levels of risk associated with purchase of value of laboratory services is increased non-prequalified products. It also advises through reliable accurate diagnosis and UNFPA and the WHO Department of the efficacy of treatment programmes is Reproductive Health and Research on improved. More patients can therefore be methods for prequalifying condoms and treated. intrauterine devices. Information and guidance Concurrently, activities to prequalify Information on WHO’s procedure for quality control laboratories are also of prequalifying diagnostics, together with great value to agencies and organizations guidance and application forms, and a who provide or fund significant quantities wide range of technical documents and of medicines for disease treatment reports, can be found at: http://www.who. programmes. National prequalified int/diagnostics_laboratory/ evaluations/ laboratories enable rapid and reliable en/ and the WHO Programme for Diag- analysis of medicines quality analysis nostics Prequalification web site is at close to locations where the medicines http://diagnostics_ laboratory technology/ are in actual use. By 2009, 11 laborato- ries have been prequalified and a further Medicines 28, most of which are in Africa, have expressed interest in becoming prequali- WHO’s list of prequalified medicines is fied or are undergoing assessment. used by the GFATM, UNICEF, the World Bank, international nongovernmental The WHO Prequalification of Medicines organizations (NGOs) and, increasingly, Programme is closely linked to WHO’s by government procurement agencies as quality assurance normative work and a basis for many procurement decisions. provides “real life” feedback for develop- Similarly, the Model Quality Assurance ment of pharmaceutical norms and Guideline developed by the WHO Pre- standards. The Programme is further qualification of Medicines Programme is linked to WHO pharmacovigilance activi- used by the US President’s Emergency ties and monitoring of adverse drug Plan for AIDS Relief (PEPFAR) and the reactions (ADRs) provides follow-up on World Bank to guide organizations that the quality and safety of prequalified procure medicines in improving their medicines. Joint planning and implemen- quality systems. tation of prospective proactive safety monitoring for selected prequalified new More generally, the WHO Prequalification products (such as an amodiaquine + of Medicines Programme has done much artesunate fixed-dose combination to ensure that medicines procured by UN product for malaria) will be an important agencies and other organizations meet source of information. 84 WHO Drug Information Vol. 24, No. 2, 2010 WHO Prequalification Programmes Capacity building The above activities contribute to: Unlike other regulatory options (such as product approvals/registration by a • more effective regulation and production stringent regulatory authority, including of medicines of assured quality; US FDA tentative approval), the WHO • more rapid development of new, quality Prequalification of Medicines Programme products; faster regulatory approval of is open to participation of regulators from products, and developing countries. For example, these regulators can actively participate in • identification of norms and standards dossier assessments and inspections. needed