WHO DRUG INFORMATION, Volume 23, Number 1
A quarterly journal providing an overview of topics relating to medicines
development and regulation targeted to a wide audience of health professionals and policy makers
www.who.int/druginformation
WHO Drug Information Digital Library
(Search engine for Volumes 1-21 from 1987 to 2007)
WHO Drug Information, Volume 24 Number 4
The final issue for 2010 features a survey on service quality provided to
manufacturers by the WHO Prequalification of Medicines Programme. Designed
to measure the level of service provided by the Programme as well as the
levels of service expected from regulatory authorities by manufacturers, the
survey includes items relevant to the assessment of product dossiers and
on-site inspections of manufacturing facilities in a way that separates
service design from service delivery. The results provide direction for
improvements to the current Programme and have implications for future
strategic development.
This first section follows with two other items of information on WHO
prequalification. The WHO Prequalification of Medicines Programme (PQP) has
recently begun prequalification of selected active pharmaceutical
ingredients for products for HIV and related diseases, malaria and
tuberculosis. A new database for vaccines prequalified by WHO by type of
vaccine, manufacturer and country of manufacture is now available on WHO's
web site. This will enable immunization programme managers, procurement
agencies, regulatory authorities and other partners to consult summary pages
for each prequalified vaccine and seek information such as date of
prequalification, vaccine presentation, route of administration, shelf life,
packaging and cold chain requirements.
The section on Safety and Efficacy highlights information on signals and
reports of adverse drug reactions, with other news from around the world,
including labelling changes. This is complemented by the section on
Regulatory Action and News which provides the most recent developments from
regulatory authorities, and particularly those having an impact on
decision-making and risk assessment. This is followed with information on
Recent Publications, Information and Events covering news on how the US
Government will share patents with the
Medicines Patent Pool followed with reports from two scientific workshops on
clinical trials and global medicines and development and evaluation of
future nanomedicines. Finally, a recent article is reviewed on lack of
opioid accessibility for pain victims.
The latest International Pharmacopoiea consultation documents are proposed
for comment on capreomycin sulfate, capreomycin for injection, efavirenz
tablets, efavirenz, emtricitabine and tenofovir tablets, emtricitabine
capsules, emtricitabine and tenofovir tablets, levamisole tablets,
levofloxacin, levofloxacin tablets and levonorgestrel tablets
The journal concludes with the 104th Proposed List of International
Nonproprietary Names (INN).
Contents
WHO Prequalification Programmes
WHO Prequalification of Medicines Programme: survey of service quality
provided to manufacturers 293
WHO initiates pilot prequalification of active pharmaceutical ingredients
297
New on-line database for WHO prequalified vaccines 298
Safety and Efficacy Issues
H1N1 influenza vaccine: narcolepsy 299
Statins: interstitial lung disease 299
Tocilizumab: risk of fatal anaphylaxis 300
Pioglitazone: potential bladder cancer 301
Angiotensin receptor blockers and cancer: safety review 301
GnRH agonists, diabetes and cardiovascular disease 301
Gadolinium-based contrast agents: kidney dysfunction 302
Lamotrigine: aseptic meningitis 302
Tinzaparin sodium: renal Impairment in elderly 303
Tamoxifen: drug interactions involving CYP2D6 genetic variants 303
Zoledronic acid solution: renal dysfunction 304
Regulatory Action and News
Influenza vaccines: 2011 southern hemisphere 305
Rosiglitazone-containing antidiabetes medicines: suspension of marketing
authorization 305
Modified-release oral opioids: suspension of marketing authorization
306
Human normal immunoglobulin: suspension of marketing authorization
306
Propoxyphene: recommendation against use 306
Sitaxentan: worldwide withdrawal 307
Sibutramine: suspension of sales 307
Sibutramine-containing medicines: withdrawal 308
Testosterone transdermal patch: withdrawal of extension of indication
application 308
Aliskiren/valsartan: withdrawal of marketing authorization application
308
Mometasone furoate/formoterol fumarate: withdrawal of marketing
authorization application 309
EMA and US FDA extend confidentiality arrangements indefinitely
309
Recent Publications, Information and Events
US Government to share patents with Medicines Patent Pool 310
Clinical trials and global medicines development 310
Evaluation of future nanomedicines 311
Reporting on opioid inaccessibility 311
Consultation Documents
The International Pharmacopoeia
Capreomycin sulfate 312
Capreomycin for injection 316
Efavirenz tablets 319
Efavirenz, emtricitabine and tenofovir tablets 323
Emtricitabine capsules 327
Emtricitabine and tenofovir tablets 330
Levamisole tablets 334
Levofloxacin 337
Levofloxacin tablets 342
Levonorgestrel tablets 346
Proposed International Nonproprietary Names List 104 351