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[e-med] WHO DRUG INFORMATION, Volume 24, Number 1

WHO Drug Information
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 1

The feature article in this first issue for 2010 provides a report from the 
WHO Prequalification of Medicines Programme. In 2009, a record 44 medicinal 
products were prequalified and by the end of the year the WHO list of 
prequalified medicines totaled 237 products manufactured in 16 countries.

The section on Regulatory Harmonization presents a summary of the WHO 
report, Assessment of medicines regulatory systems in sub-Saharan African 
countries, which synthesizes the findings of rapid assessments performed at 
national medicines regulatory authorities in 26 African countries. The 
report sheds light on the urgent need for regulatory capacity strengthening 
in African countries and proposes action for sustainable progress.

An article concerning International Nonproprietary Names discusses the 
glycosylation pattern of epoetins whereby the need for a unique INN for each 
independently manufactured epoetin is proposed.

The section on Regulatory Scope presents a brief overview of the challenges 
facing regulation of electronic nicotine delivery systems. These deliver 
nicotine and other substances but do not contain tobacco and they may fall 
outside the scope of regulatory regimes for tobacco products. Nevertheless, 
the fact that they are marketed as alternatives to cigarette smoking 
indicate the need to characterize, regulate and ensure that the public is 
properly informed of the potential health hazards.

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-making and 
risk assessment.

The journal concludes with Recent Publications, Information and Events  and 
Recommended List number 63 of International Nonproprietary Names (INN).


CONTENTS

Prequalification of Medicines Programme
WHO Prequalification of Medicines Programme: facts and figures for 2009 
3

Regulatory Harmonization
Updating medicines regulatory systems in sub-Saharan African countries 
6

International Nonproprietary Names
The glycosylation pattern of epoetins 
21

Safety and Efficacy Issues
Didanosine: serious liver disorder 
25
Bortezomib: updated safety information 
25
Deferasirox: renal events and gastrointestinal haemorrhage            25
Sirolimus: drug monitoring assay comparison 
26
Mycophenolate: pure red cell aplasia 
26
Fosamprenavir: myocardial infarction and dyslipidaemia                  27
Exenatide: altered kidney function 
27
Drospirenone in oral contraceptives 
28
Glucose test strips 
28
HIV drug combination: safety review of clinical trial data 
28
Sibutramine: ongoing safety review 
29
Becaplermin: contraindication in patients with cancer 
29
ACSOM - advisory committee on safety of medicines                    29

Regulatory Scope
Tobacco product regulation 
30

Regulatory Action and News
Influenza vaccines: 2010-2011 northern hemisphere 
33
European Medicines Agency: new organizational structure and visual identity 
33
Risk management systems for medicinal products 
34
Orciprenaline sulphate: registration cancelled 
35
Peramivir IV: emergency use authorization 
35
Carisbamate: withdrawal of marketing authorization application       35
Benfluorex withdrawal 
35
Ethyl eicosapent: withdrawal of marketing authorization application 36
Olanzapine approved in adolescents 
36
Lisuride: withdrawal of marketing authorization application               36
Velaglucerase alfa approved for Gaucher disease 
37
Pneumococcal 13-valent conjugate vaccine approved 
37
Monoclonal antibody products approved for chronic lymphocytic leukaemia 
37
Rosuvastatin: new indication approved 
38
Influenza A/H1N1: collection-to-detection assay 
38

Recent Publications, Information and Events
TSE tissue infectivity distribution update 
39
Restricted availability of opioids for cancer patients 
39
Transparency and the public pharmaceutical sector                         40

Recommended International Nonproprietary Names
List 63 
41

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