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WHO DRUG INFORMATION VOLUME 20• NUMBER 2 • 2006 PROPOSED INN LIST 95 INTERNATIONAL NONPROPRIETARY N A M E S F O R P H A R M A C E U T I C A L SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information Vol 20, No. 2, 2006 World Health Organization WHO Drug Information Contents Regulatory Issues Fluoxetine approved for children and adolescents 89 Drug Regulation in 2006: vision Withdrawal of marketing application for and challenges 61 Surfaxin® 89 International Conference of Drug Resumed marketing of natalizumab 90 Regulatory Authorities (ICDRA): EU Regulation on compulsory licensing recommendations 61 published 90 Safety and Efficacy Issues Emerging Diseases Tenofovir and nonsteroidal anti- Tissue infectivity and transmissible inflammatories: acute renal failure 69 spongiform encephalopathies 91 Update on status of contraceptive skin patch 69 SSRI antidepressants linked to lung ATC/DDD Classification disorder in newborns 70 ATC/DDD Classification (temporary) 97 ACE inhibitors and birth defects 70 ATC/DDD Classification (final) 100 ACE inhibitors and pregnancy 71 Gadolinium-containing contrast agents Recent Publications, and nephrogenic systemic fibrosis 71 Gatifloxacin and blood glucose Information and Events disturbances 72 Interagency Emergency Health Kit 2006 103 Therapeutic guidelines for rheumatology 103 Essential Medicines Specifications for pharmaceutical preparations 103 WHO Model List of Essential Medicines New guidance for pharmacists on and developed countries: a comparison counterfeit medicines 104 with the Lothian Joint Formulary 73 Marketed unapproved drugs — policy Adherence to WHO’s Model List of guide 104 Essential Medicines in two European WHO guidelines on avian influenza 104 countries 78 WHO analgesic ladder 105 Resources for paediatric formulations 104 Regulatory Action and News Transgenic antithrombin alfa approved 86 Consultation Document EMEA Management Board moves for International Pharmacopoeia: revision greater transparency 86 of monographs for antimalarials and Bupropion approved for seasonal draft proposals for antiretrovirals depression 86 Artesunate 106 Decitabine approved for myelodysplastic Artesunate tablets 107 syndromes 87 Lamivudine oral solution 107 Medical device innovation initiative 88 Lamivudine tablets 109 Topotecan/cisplatin for late-stage cervical Zidovudine and lamivudine tablets 112 cancer 88 Rapid approval of vaccine for prevention of cervical cancer 89 Proposed International Rasagiline approved for Parkinson Nonproprietary Names: disease 89 List 95 115 59 WHO Drug Information Vol 20, No. 2, 2006 Regulatory Issues Drug regulation in 2006: vision and challenges The Twelfth International Conference of Drug Regulatory Authorities (ICDRA) held in Seoul, Republic of Korea, from 3 to 6 April 2006 has once again provided drug regulators with a unique opportunity to meet and discuss the particular challenges of medicines regulation. The continuing need to harmonize and strengthen collaboration is underscored by the increasing complexity of the medicines market and technical skills needed to regulate innovative prod- ucts. The latest ICDRA was hosted by the Korea Food and Drug Administration in collabora- tion with the World Health Organization. The event was highly appreciated by developed and developing countries for its continuing role in fostering a regulatory forum where matters of urgency and international relevance can be openly debated. On this occasion, the event led to adoption of the following recommendations which regulators consider important in assuring the quality, safety and efficacy of medical products. International Conference of Drug Regulatory Authorities (ICDRA): recommendations Access to medicines: new regulatory medicines of quality which address public pathways for public health needs health needs. 1. In the assessment of products, particularly Emerging diseases and crises those developed for public health needs, management: regulatory challenges countries should make use of new regulatory pathways provided by highly-evolved regula- 1. The fight against emerging diseases tory agencies in order to avoid duplication of requires global collaboration and multi- effort. This would enable optimal use of limited disciplinary effort. Member states should resources. ensure their national regulatory agencies are closely involved in national strategic decision 2. In cooperation with well resourced regula- making processes and are engaged as key tory agencies, WHO is urged to assist Mem- stakeholders in national contingency planning. ber States to provide training on the best use In this context, national regulatory agencies of regulatory information on product approvals should develop business continuity plans and available in the public domain. may also have a role in facilitating vaccine and pharmaceutical research and develop- 3. WHO should continue its efforts to ment, and development of blood screening prequalify active pharmaceutical ingredients tests. for medicines for priority diseases, including HIV/AIDS, malaria and tuberculosis. Informa- 2. WHO should take a leading role in the tion concerning prequalified products and global preparedness for pandemic infections. approved sites should continue to be made Central to its role as the global leading health public in the form of WHO public inspection agency, WHO should cooperate with Member reports. States to ensure transparency of epidemio- logical information, co-ordinate information 4. WHO should assist national regulatory and technology transfer on clinical trials and agencies to develop innovative approaches to research and assist Member States through improve access to safe and effective essential developing WHO standards for pre-marketing 61 World Health Organization WHO Drug Information Vol 20, No. 2, 2006 WHO Drug Information e-mail table of contents and subscriptions available at: http://www.who.int/druginformation 60 Regulatory Issues WHO Drug Information Vol 20, No. 2, 2006 evaluation of pharmaceuticals developed for caregivers will have better information upon pandemic use. It is important for national which to make choices. Furthermore, the regulatory agencies to find mechanisms to publication of various risk management share clinical trial results and epidemiological guidances, the improvement of scientific data. National regulatory agencies should not methods of adverse event signal detection and allow the threat of pandemics to compromise better and earlier communication of drug safety the principles of safety, efficacy and quality of concerns to health professionals and the public vaccines and pharmaceuticals being consid- are being developed. In addressing challenges ered for licensing approval. of obtaining quality adverse event reports, cooperation between regulatory agencies and 3. National regulatory agencies should ensure communicating effectively with the public are that robust post-marking surveillance systems foremost. are in place to ensure that pharmaceuticals approved during a pandemic will continue to Member States should: be closely monitored and subject to further 1. Develop ways to ensure early communica- assessment of their safety, efficacy and tion to the public when an emerging safety quality. To achieve this, national regulatory concern arises. agencies should work with, among others, authorities for disease surveillance and the 2. Give patients, healthcare professionals and vaccine and pharmaceutical industry as close consumers quick and easy access to the most partners. up-to-date and accurate information on medicines. 4. During a pandemic, the demand for blood and blood products is likely to increase. On 3. Encourage participation in WHO activities the other hand, there could be lack of blood for reporting and collecting adverse reactions donations because of high morbidity and to medicines and vaccines, and seek ways to mortality of prospective donors. WHO should enhance reporting rates. assist Member States -when drawing up contingency plans to include measures to 4. Improve scientific methods of adverse event maintain the integrity of their blood transfusion signal detection. system, the continued supply of blood and blood products, and maintain transparency WHO and Member States should: and information sharing. New challenges in safety of medicines 5. Encourage pharmacovigilance planning in all public health programmes wherever High-profile drug safety issues present possible. numerous challenges for drug regulators. New ways to improve knowledge about benefit/risk WHO should: assessment, methods of signal detection, and communications to health professionals and 6. Encourage cooperation between regulatory the public are continually being sought. authorities when a new signal emerges. Spontaneous adverse drug reaction reporting has long been the cornerstone of pharma- Herbal medicines: covigilance and continues to serve a vital safety through quality function, but changes in public expectations and drug development are encouraging 1. Quality control of herbal medicines is regulators to think about pharmacovigilance complicated and difficult, and high-technology as early as possible in the product life cycle. could be of valuable support. However, when country capacity is limited, continued use of The aim of pharmacovigilance planning is to dependable basic technical methods and tests provide regulators with a proactive approach is recommended. to filling in knowledge gaps, while also improving the probability of detecting impor- 2. Governments should provide