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WHO Drug Information

WHO drug Information Vol. 31, No. 2, 2017 WHO drug Information Contents Medicines regulation Regulatory news 153 Regulating medicine manufacturers: 177 Pre-market assessment is an on-site inspection the only Assessment of generics in China; New fast- option? track pathway in India ; australian orphan drug programme; EU Priority medicines 158 Placebo and drug kits in clinical trial scheme; EU medical devices regulation design 179 Adverse events reporting Pharmacovigilance in Europe; Adverse events of illicit drugs in UK. Quality monitoring 180 Supply 162 Survey of the quality of selected GMP for compounded medicines; Reporting antiretroviral medicines circulating in of shortages in Canada; Dispensing five African countries categories in Switzerland 180 Antimicrobial resistance India national action plan; New investments in Safety news Canada; Tripartite alignment on requirements 166 Safety warnings for antibacterials Dulaglutide; Darbepoetin alfa ; Caspofungin 181 Collaboration ; Pneumococcal vaccine ; Pembrolizumab EU and African regulators meet; Report on ; Vemurafenib ; Denosumab; Gadolinium EMA FDA assessment pilot; Swiss A

153 WHO Drug Information Vol. 31, No. 2, 2017 Medicines regulation Regulating medicine manufacturers: is an on-site inspection the only option? The Australian approach to …

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