viernes, 10 de abril de 2015

WHO Drug Information Vol. 29, No. 1, 2015

OMS, abril 2015
Regulatory collaboration
The International Coalition of Medicines Regulatory Authorities (ICMRA)
Norms and standards
 Good review practices: guidelines for national and regional regulatory authorities
Safety news
Metoclopramide: not for children under one year of age;
Domperidone: further restrictions;
Nitrofurantoine: revised contraindication in renal impairment;
Oral diclofenac: prescription-only in United Kingdom;
Risperidone: not to be used in vascular or mixed-type dementia;
Hydroxyzine: new restrictions;
Codeine containing cough and cold medicines: not for children under 12;
Safety warnings
Linagliptin: possible liver toxicity;
Apixaban: interstitial lung disease;
Chlorhexidine: chemical burns in premature infants;
 Testosterone: caution about use in healthy men;
Telaprevir: renal impairment;
Simeprevir: leukopenia and neutropenia;
Mycophenolate mofetil and mycophenolic acid: hypogammaglobulinaemia and bronchiectasis; Vemurafenib: pancreatitis;
Abiraterone: thrombocytopenia;
Ziprasidone: rare but potentially fatal skin reactions;
Donepezil: rhabdomyolysis and neuroleptic malignant syndrome;
Ambroxol/bromhexine: rare severe skin reactions;
Nitric oxide cylinders: faulty valves ;
Unchanged recommendations
Analgesics in pregnancy
Manufacturing quality issues
GVK Biosciences: EMA recommends suspensions; Three Indian sites: Canada stops imports;
Falsified product alert
Falsified artemether/lumefantrine in West Africa
Regulatory news
Pre-market assessment
Generics information-sharing pilot expanded;
CFDA issues biosimilars development and evaluation guideline
EMA upgrades data systems;
Canada launches drug safety information web site
Regulatory oversight
FDA proposes new guidance on compounding;
CFDA strengthens good practice guidance for medical devices
EMA advice on antibiotics use in animals;
ECDC/EFSA/EMA first joint report
Drug availability
Canada announces requirement for reporting of drug shortages ;
EU industry proposal on reducing manufacturing-related medicines shortages
Bupropion & naltrexone: for weight management;
Liraglutide: for weight management;
Cangrelor: anti-clotting agent;
Edoxaban: anti-clotting agent;
Tolvaptan: for rare kidney disease;
Parathyroid hormone: to control blood calcium levels in hypoparathyroidism ;
Ceftolozane & tazobactam: for certain complicated infections;
Ceftazidime & avibactam: for certain complicated infections;
Finafloxacin: for outer ear infection ;
Peramivir: for influenza;
Lamivudine & raltegravir;
Meningococcal serogroup B vaccine ;
Human Papillomavirus 9-valent Vaccine, Recombinant: for prevention of certain cancers;
Sabin inactivated polio vaccine (sIPV);
Ceritinib: for certain lung cancers;
Nivolumab: for advanced melanoma , lung cancer;
Lenvatinib: for certain progressive thyroid cancers;
 Palbociclib: for advanced breast cancer;
 Safinamide: for Parkinson’s disease;
Autologous limbal stem cells: for limbal stem cell deficiency due to burns to the eyes;
Extensions of indications
Labelling changes
Diabetes pen devices: for single-patient use only;
Xpert® MTB/RIF test: can guide decisions on ending patient isolation;
Publications and events
Access to treatment
Adaptive licensing pathways; Appraisal of expensive medicines; BRICS Ministers tackle priority diseases; LDCs request extension of intellectual property rights waiver for medicines; Medicines Patent Pool signs licensing agreements for paediatric antiretrovirals; Anti-TB drug donation agreed
 Product development
New anti-tuberculosis medicine starts clinical testing
Disease updates
Ebola: an unforgiving virus; Non-communicable diseases: preventable early deaths; Tuberculosis: further to go; Malaria: fragile gains; HIV: fast track targets; Neglected tropical diseases: domestic investments needed;
 WHO matters
MQAS procurement guidelines now available in French;
Do you manufacture these APIs?
We are interested in you;
New phase of WHO’s external quality control laboratory scheme;
WHA resolutions now on oficial record;
 WHA67.20: Regulatory system strengthening for medical products;
WHA67.21: Access to biotherapeutic products, including similar biotherapeutic products, and  ensuring their quality, safety and efficacy;
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