WHO Drug Information Vol. 25, No. 1, 2011 World Health Organization WHO Drug Information Contents International Harmonization Mometasone furoate/formoterol fumarate: 14th International Conference of Drug withdrawal of marketing authorization Regulatory Authorities 1 application 37 International Conference of Drug Briakinumab: withdrawal of marketing Regulatory Authorities: personal authorization application 37 reminiscences 18 Omacetaxine mepesuccinate: withdrawal of marketing authorization application 38 Zoledronic acid: withdrawal of application WHO Prequalification of for an extension of indication 38 Medicines Programme Pandemic influenza vaccine (H5N1): Inspection of API manufacturing sites 24 withdrawal of marketing authorization application 38 Safety and Efficacy Issues ENCePP launch electronic register ATC/DDD Classification of studies 28 ATC/DDD Classification (temporary) 40 Methysergide and retroperitoneal fibrosis 28 ATC/DDD Classification (final) 43 Clozapine and life-threatening gastro- intestinal hypomotility 29 Recent Publications, Tamoxifen and anti-depressants: drug interaction 30 Information and Events Dronedarone : severe liver injury 31 Assessment of 26 African regulatory Dolasetron mesylate: abnormal heart authorities 46 rhythm 32 Quality of antimalarials in sub-Saharan Sitaxentan: update following withdrawal 32 Africa 46 Bevacizumab use in breast cancer Good governance for medicines 47 treatment 33 EC/ACP/WHO Partnership on Pharma- Latest developments in pharmaco- ceutical Policies 47 vigilance 33 Recommended International Regulatory Action and News Nonproprietary Names Influenza Global operation against illegal List 65 49 and counterfeit medicines 37 1 World Health Organization WHO Drug Information Vol. 25, No. 1, 2011 WHO Drug Information Digital Library, e-mail table of contents and subscriptions available at: http://www.who.int/druginformation 2 WHO Drug Information Vol. 25, No. 1, 2011 International Harmonization 14th International Conference of Drug Regulatory Authorities The success of the recent 14th International Conference of Drug Regulatory Authori- ties (ICDRA) held in Singapore from 30 November to 3 December was attested by the presence of 345 participants from over 90 agencies. In addition to the event, partici- pants were invited to celebrate thirty years of ICDRAs. Both developed and develop- ing country officials joined in confirming the value and impact of this forum to national, regional and international medicines regulation by contributing to seven plenaries and nineteen parallel workshops. The quality of the information offered and the lively dis- cussion led to adoption of recommendations which regulators consider important in assuring the quality, safety and efficacy of medicines. These are set out below and on the following pages. The 14th ICDRA was hosted by the Health Sciences Authority of Singapore in collabo- ration with the World Health Organization. The Conference continues to be a corner- stone of international harmonization of medicines regulation and is highly appreciated for the platform it provides in highlighting matters of urgency and relevance to an often difficult but vital sector of the health care system. ICDRA RECOMMENDATIONS Improving drug regulation action between regulatory agencies and as part of health systems civil society, scientific institutions, strengthening governmentally-managed health insur- ance systems and reimbursement Major trends relating to regulatory support schemes. for medical products present medicines Given the current fast-paced and exacting agencies and WHO with numerous climate, it is difficult for regulators to draw challenges. The increasing complexity of a fair balance between the potential risks regulatory work — whether as a result of of a new medicine and public expecta- new technologies, globalization of com- tions of availability and safety. Addition- mercial activities or internationalization of ally, the introduction of high performance product development — is particularly information systems and instant access onerous. together with demand for relevant, quality Increasing autonomy of management and information puts greater pressure on decision-making in governmental regula- regulators to react professionally and with tory systems, together with greater transparency in a minimum of time. interaction between regulators and the private sector in the development of In spite of many positive developments in standards and regulations has led to the the Global regulatory arena it is worrying need for greater efforts to improve inter- that the gaps among regulatory systems 3 International Harmonization WHO Drug Information Vol. 25, No. 1, 2011 are rather increasing than decreasing. Medicines regulatory authorities should: This is partly caused by the human and financial resource gap existing between • Commit to and collaborate in prioritizing, well-resourced and resource-constrained developing and teaching regulatory settings. science to strengthen scientific robust- ness in advancing regulatory innovation A medical products regulatory system, and thought leadership, exploring new supported by relevant legislation, is an regulatory tools and frameworks, and essential component of a functioning conducting environmental scanning. health system. A medicines regulatory system includes, at the very least, the • Keep abreast of developments in health necessary legislation and regulation, a technology assessment to minimize regulatory authority which subjects all duplication of activities and explore pharmaceutical products to premarketing ways to better interface with parties evaluation, marketing authorization and involved in health technology assess- postmarketing surveillance. The regula- ment. tory system should also include an • Take account of the wider health and inspectorate, access to a medicines non-health environment in which they quality control laboratory, enforcement operate nationally and internationally, mechanisms and safety monitoring. proactively strengthen networks, en- Moderators gage stakeholders, and clarify policies John Lim, Singapore and Thomas and positions in order to enhance their Lönngren, European Union regulatory mission and effectiveness, especially in crisis preparedness and Presentations risk management. Challenges of biomedical advancement – • Work with their governments to reiterate evolving role of the regulator. John Lim, to the WHO governing bodies (World Singapore Health Assembly and Executive Board) Drug regulation and public health in the the importance of strengthening regula- EU. Thomas Lönngren, EU tory capacity and cooperation as an essential part of overall health systems Strengthening regulatory capacity around strengthening. the Globe: our common and vital interest. Margaret Hamburg, USA Collaboration and cooperation among Recommendations regulatory agencies WHO should: The rapid advancement in biomedical • Continue to assist medicines regulatory sciences and the invention of novel authorities (MRAs) in garnering political therapeutic products have made it more support at national or regional levels to critical than ever for medicines regulatory build regulatory capacity. agencies to work together to achieve the goal of protecting and advancing public • Work with Member States in ongoing health. promotion of collaboration and coordi- nation to develop MRA capacity in The 14th ICDRA re-affirmed the impor- pharmacovigilance, identifying core tance of regional harmonization efforts minimum functions, and mapping of which are already on-going in different major initiatives that may facilitate parts of the world in various forms and cooperation. models. It was also recognized that WHO 4 WHO Drug Information Vol. 25, No. 1, 2011 International Harmonization could further support these collaborative • Provide a protected electronic platform initiatives by providing technical assist- for regulators to share information and ance where capacity building is needed. experience on specific regulatory topics Furthermore, WHO is in a unique position of common interests, similar to that for to facilitate networking and information the Paediatric Medicines Regulators exchange among regulators. Network (PmRN). Moderators • Facilitate twinning of less developed Supriya Sharma, Canada and Christina agencies with well-established agencies Lim, Singapore for capacity building and training. Presentations Report from the pre-ICDRA meeting: Recent developments in cooperation of Effective collaboration: the future regulatory authorities among ASEAN for medicines regulation countries. Yuppadee Javrongrit, Thailand Recommendations Collaboration among regulatory authori- ties in the European Union: a micro- Promotion of increased regulatory agency perspective. Alar Irs, Estonia effectiveness First joint product assessment experience WHO should: from EAC partner states. Hiiti Sillo, Tanzania • Actively promote cooperation and collaboration programmes and use information generated by other MRAs Reporting back from the pre-ICDRA meeting. Stewart Jessamine, New Zea- as a tool to improve regulatory capacity land and effectiveness. • Collect best practices of collaboration Recommendations and cooperation between medicines regulatory authorities including informa- Regional working groups should: tion exchange, joint assessments and • Strengthen efforts to build capacity to inspections and activities aimed at reducing duplication. develop/adopt common technical standards and requirements. • Work with national MRAs to