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WHO Drug Information Vol WHO Drug Information Vol. 29, No. 3, 2015 WHO Drug Information Contents Norms and standards 342 Antibiotics FDA regulation on use of antibiotics in food- 305 Assessing new medical products in health producing animals emergencies: the EUAL procedures 343 Herbal medicines EMA publishes scientific opinions on herbal medicines Medicines for women and children 343 Collaboration 324 Quality and availability of selected life-saving CFDA joins the ICMRA Interim Management reproductive health medicines in developing Committee ; PMDA publishes 2015 Strategic countries International Plan; EU and Swiss regulators sign confidentiality arrangement; First international generic drug regulators’ meeting Safety news held; Central African countries aim for 334 Restrictions regulatory harmonization Repaglinide : contraindicated with clopidogrel; 344 Law enforcement 334 Safety warnings Operation Pangea VIII nets record amount of Sitagliptin, saxagliptin, linagliptin, alogliptin : potentially dangerous products severe joint pain; Anagliptin : intestinal obstruction ; SGLT2 inhibitors : atypical diabetic ketoacidosis; Epoetin 345 Successful Phase III trial beta : possible increased risk of retinopathy in preterm infants; Adefovir pivoxil : fractures; Ingenol mebutate : Ebola vaccine : shown to be highly effective severe allergic reactions and herpes zoster; Asunaprevir, daclatasvir : decreased hepatic residual function; Influenza HA 345 Approved vaccine : optic neuritis; Abiraterone acetate : fulminant hepatitis, hepatic failure; Fingolimod : Rolapitant : for chemotherapy-induced nausea and vomiting; Asfotase alfa : for rare bone disease; Cangrelor : to prevent blood clotting during surgery; progressive multifocal leukoencephalopathy; Methylphenidate patches : permanent skin discolouration; Diazoxide : pulmonary Guanfacin : for attention deficit hyperactivity disorder; Valsartan & sacubitril : for heart failure; Alirocumab : hypertension; General use syringes : not to be used to store medicines; to lower cholesterol levels; Plasmodium falciparum (malaria) vaccine 337 Known risks ; Gefitinib : for certain lung cancers; Sonidegib : for locally advanced basal cell carcinoma; Brexpiprazole : for schizophrenia major depressive Ivabradine : heart problems in patients with angina ; Indapamide : toxic epidermal necrolysis ; NSAIDs: heart attack or disorder; Flibanserin : for acquired, generalized female hypoactive sexual desire disorder; Lumacaftor & ivacaftor : for cystic fibrosis; stroke; Paracetamol : additional measures for safe use; Diagnostic test to differentiate between types 338 Unchanged recommendations of HIV infection New anti-coagulants : No evidence to support routine blood monitoring; Retigabin (ezogabine) : long-term study on pigment changes; 349 Additional use approved 339 Safety reviews started Eltrombopag : to increase platelet counts in children with rare blood disorder; 339 WHO Notices of Concern Quest Life Sciences ; Svizera Labs Pvt Ltd 340 Falsified product alert Publications and events Falsified diazepam in Central Africa 350 Public health Special journal issue on vaccine hesitancy; First-ever report on global health Regulatory news service coverage; Meningitis C vaccine 341 Pre-approval processes needed EMA supports development of children’s 351 WHO matters medicines; TGA implements eCTD WHO response to the Ebola interim submissions; EMA proposes amendments to assessment panel report; Updated invitations good clinical practice guidelines for WHO prequalification 342 Post-marketing control 351 Upcoming events EMA launches pilot for voluntary post- Reminder – Joint WHO-UNICEF-UNFPA authorization safety studies; Medsafe meeting with manufacturers publishes revised pharmacovigilance guidelines Continued 303 WHO Drug Information Vol. 29, No. 3, 2015 Continued Consultation documents 383 Levomethorphan limit test for dextromethorphan-containing finished 352 The International Pharmacopoeia pharmaceutical products 352 Carbamazepine 357 Carbamazepine tablets 360 Carbamazepine chewable tablets International Nonproprietary 363 Carbamazepine oral suspension Names (INN) 366 Norethisterone 371 Norethisterone tablets 385 Recommended INN: List 74 375 Dextromethorphan hydrobromide 380 Dextromethorphan oral solution Abbreviations and web sites CHMP Committee for Medicinal Products for Human Use (EMA) EMA European Medicines Agency (www.ema.europa.eu) EU European Union FDA U.S. Food and Drug Administration (www.fda.gov) Health Canada Federal department responsible for health product regulation in Canada (www.hc-sc.gc.ca) MHLW Ministry of Health, Labour and Welfare, Japan MHRA Medicines and Healthcare Products Regulatory Agency, United Kingdom (www.mhra.gov.uk) Medsafe New Zealand Medicines and Medical Devices Safety Authority (www.medsafe.govt.nz) PRAC Pharmacovigilance Risk Assessment Committee (EMA) PMDA Pharmaceuticals and Medical Devices Agency, Japan (www.pmda.go.jp/english/index.htm) Swissmedic Swiss Agency for Therapeutic Products (www.swissmedic.ch) TGA Therapeutic Goods Administration, Australia (www.tga.gov.au) U.S. United States of America Note: The online version of this issue (available at www.who.int/medicines/publications/druginformation) has direct clickable hyperlinks to the documents and web pages referenced. 304 WHO Drug Information Vol. 29, No. 3, 2015 Norms and standards Assessing new medical products in health emergencies: the EUAL procedures Development and regulatory approval of medical products typically take many years. When an unprecedented Ebola outbreak devastated West African countries and kept on spreading, there were no approved vaccines, medicines or rapid diagnostic tests available to combat the disease. A WHO-convened ethical panel reached consensus that in this special situation, and provided certain conditions were met, it was ethical to use investigational products. In the months that followed, WHO not only convened global players to accelerate R & D for Ebola, but also developed rules on how to identify those investigational products that can be used in an emergency – with the agreement of the competent regulatory authority – while they are being studied further. The Emergency Use Assessment and Listing (EUAL) procedures are the first of their kind of a global nature. They are a step ahead in ensuring that the world is prepared for future emergencies. Unmet medical needs declared the Ebola outbreak to be a New medical products are approved every public health emergency of international year to treat the diseases that continue concern. to threaten the world’s populations, such Vaccines, treatments and diagnostics as cancer or diabetes. Research and were now urgently needed to contain the development (R & D) and regulatory outbreak, save lives and relieve suffering. approval of new products typically On 11 August 2014 a WHO-convened take many years and require long-term panel reached consensus that in the planning of investments. particular circumstances of the Ebola Ebola outbreaks have been known outbreak, and provided certain conditions to occur since 1976 (1), but they were are met, it is ethical to offer unproven always quickly contained with infection interventions that have shown promising control measures. When an Ebola results in the laboratory and in animal outbreak was confirmed in March 2014, models but have not yet been evaluated there was no approved medical product for safety and efficacy in humans as for the prevention or treatment of Ebola potential treatment or prevention (3). virus disease. However, this outbreak turned out to be unprecedented in size WHO leadership and complexity, with over 27 000 cases The panel of independent experts and 11 000 deaths on record in the most who reviewed WHO’s response to the recent WHO Ebola Situation report (2). On Ebola outbreak has commended the 8 August 2014 the WHO Director-General Organization for stepping up to fill a void 305 Norms and standards WHO Drug Information Vol. 29, No. 3, 2015 “We now know that the urgency of saving lives can accelerate R&D. We will harness this positive experience to develop a global R&D preparedness framework so that if another major disease outbreak ever happens again, for any disease, the world can act quickly and efficiently to develop and use medical tools and prevent a large- scale tragedy.” Marie Paule Kieny, WHO Assistant Director-General and WHO Ebola R & D team lead at a critical stage of the Ebola outbreak target countries to authorize the use of the (4). WHO’s Ebola R & D team successfully listed products in their territories. convened international partners to fast- WHO regulatory experts have long- track the development of needed products standing experience in identifying the best and provided leadership in the conduct of options of providing needed treatment trials for candidate vaccines and in the use when stringently approved products are of experimental therapies such as drugs out of reach. The WHO Prequalification and blood products. Team (PQT) assesses vaccines, When this race for time began, there medicines and diagnostic products for use was no guidance available on how to test in UN and donor-funded programmes. any candidate products in an emergency The head of the Ebola R&D Regulation situation, or how to regulate them. The group and most of its members came from Regulation group of the WHO Ebola PQT, and the group could thus draw on a R & D team rose to the task and worked vast amount of experience with regulation against the clock to propose a new model and manufacturing of medical products.
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