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[e-med] WHO DRUG INFORMATION, Volume 23, Number 4

WHO Drug Information is 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 <http://www.who.int/druginformation> 

WHO Drug Information Digital Library

(Search engine for Volumes 1-21 from 1987 to 2007)

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WHO Drug Information, Volume 23 Number 4


The feature article in this final issue for 2009 describes how development
of recombinant biotechnology products has created a need for adaptation of
the International Nonproprietary Name system and presents WHO?s response to
the challenges of this evolution.
 

Despite technological advances, controlling the quality, safety and efficacy
of biologicals remains difficult and highly specialized so that
strengthening biological standardization and its implementation remains a
fundamental function for WHO through its Expert Committees and Expert
Advisory Panels. Conclusions and recommendations from the latest meeting of
the Expert Committee on Biological Standardization are presented under
Biomedicines and Vaccines

The section Pharmacovigilance Focus describes the A/H1N1 vaccination safety
PaniFlow® surveillance tool which was launched as a result of collaboration
between WHO and The Swiss Agency for Therapeutic Products, Swissmedic.   

In collaboration with UNAIDS, UNICEF, UNFPA, the Global Fund, UNITAID, with
support from the World Bank, WHO has set up a process to prequalify quality
control laboratories that meet recommended international norms and standards
for the analysis of medicines prequalified or being considered for
prequalification by WHO. This article describes the assessment process for
quality control laboratories and follows with a brief summary of inspection
and monitoring results to date.

International Harmonization provides updated information on the latest
developments and recommendations from the ICH quality working groups and
pharmacopoeial group discussions.

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 section is complemented by Regulatory
Action and News which provides the most recent developments from regulatory
authorities, and particularly those having an impact on decision-taking. 

The International Pharmacopoeia Consultation Documents section covering
artesunate and artesunate tablets is followed by Recent Publications,
Information and Events.

The journal concludes with Proposed List number 102 of International
Nonproprietary Names (INN).


CONTENTS
 
International Nonproprietary Names
INN identifiers for biological products               273

Safety and Efficacy Issues
Rituximab: multifocal leuko-encephalopathy            282
Darbepoetin alfa: risk of stroke                      282
Vigabatrin and movement disorders                     283
Alendronate: risk of low-energy femoral shaft fracture 283
Ceftriaxone and calcium containing solutions          284
Etravirine: severe skin and hypersensitivity reactions   285
Oseltamivir phosphate: dosing risk                    285
Safety signal: hyponatraemia                          286
Clopidogrel and omeprazole: reduced effectiveness     286
Bisphosphonates: osteonecrosis of the jaw             287
Intravenous promethazine: serious tissue injuries     287
Cyproterone: risk of meningiomas                      288
Gadolinium-containing contrast agents                 289
Cesium chloride: cardiac risks                        290
Washout or taper when switching antidepressants       290
Zanamivir inhalation powder must not be nebulized     291
Pandemrix®: risk of fever                             291
Weekly pandemic pharmacovigilance updates             292

Biomedicines and Vaccines
International biological standards: 2009 update       293

International Harmonization
ICH Implementation: Quality Working Groups            296
ICH Pharmacopoeial Discussion Group                   297

Prequalification of Medicines Programme
Prequalification of quality control laboratories      300

Pharmacovigilance Focus
A/H1N1 vaccination safety: PaniFlow®surveillance tool 305       

Regulatory Action and News
Influenza vaccines for 2010 southern hemisphere winter 306
Romidepsin: approved for cutaneous T-cell lymphoma     306
Orciprenaline sulphate: withdrawal                     306
Artemisinin antimalarials: not for use as monotherapy  307
Vitespen: withdrawal of marketing authorization application    307
Aripiprazole: withdrawal of application for extension of indication   307
Substandard and counterfeit medicines: USAID?USP Agreement   308
Vandetinib: withdrawal of marketing authorization application   308

Consultation Document
International Pharmacopoeia
Artesunate                                                      309
Artesunate tablets                                            313

Recent Publications, Information and Events
Illegal weight-loss medicines and dietary supplements    318
Southern Med Review                                         318

Proposed International Nonproprietary Names 
List 102                        319





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