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

Restrictions

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

 

 Pharmacovigilance

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

 

Antibiotics

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

 

Approvals

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;

 

Disponible en

http://apps.who.int/medicinedocs/documents/s21798en/s21798en.pdf