Cancer

WHO Drug Information Vol. 25, No. 1, 2011

World Health Organization

WHO Drug Information
Contents
International Harmonization
14th International Conference of Drug
Regulatory Authorities
International Conference of Drug
Regulatory Authorities: personal
reminiscences

1
18

WHO Prequalification of
Medicines Programme
Inspection of API manufacturing sites

24

Safety andEfficacy Issues
ENCePP launch electronic register
of studies
Methysergide and retroperitoneal fibrosis
Clozapine and life-threatening gastrointestinal hypomotility
Tamoxifen and anti-depressants: drug
interaction
Dronedarone : severe liver injury
Dolasetron mesylate: abnormal heart
rhythm
Sitaxentan: update following withdrawal
Bevacizumab use in breast cancer
treatment
Latestdevelopments in pharmacovigilance

Mometasone furoate/formoterol fumarate:
withdrawal of marketing authorization
application
37
Briakinumab: withdrawal of marketing
authorization application
37
Omacetaxine mepesuccinate: withdrawal
of marketing authorization application 38
Zoledronic acid: withdrawal of application
for an extension of indication
38
Pandemic influenza vaccine (H5N1):withdrawal of marketing authorization
application
38

ATC/DDD Classification
28
28

ATC/DDD Classification (temporary)
ATC/DDD Classification (final)

29

Recent Publications,
Information and Events

30
31
32
32
33

Assessment of 26 African regulatory
authorities
Quality of antimalarials in sub-Saharan
Africa
Good governance for medicines
EC/ACP/WHO Partnership on PharmaceuticalPolicies

40
43

46
46
47
47

33

Regulatory Action and News
Influenza Global operation against illegal
and counterfeit medicines
37

Recommended International
Nonproprietary Names
List 65

49

1

World Health Organization

WHO Drug Information Vol. 25, No. 1, 2011

WHO Drug Information
Digital Library,
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2

WHO Drug Information Vol. 25, No. 1, 2011

International Harmonization
14th International Conference of Drug Regulatory
Authorities
The success of the recent 14th International Conference of Drug Regulatory Authorities (ICDRA) held in Singapore from 30 November to 3 December was attested by the
presence of 345 participants from over 90 agencies. Inaddition to the event, participants were invited to celebrate thirty years of ICDRAs. Both developed and developing country officials joined in confirming the value and impact of this forum to national,
regional and international medicines regulation by contributing to seven plenaries and
nineteen parallel workshops. The quality of the information offered and the lively discussion led to adoptionof recommendations which regulators consider important in
assuring the quality, safety and efficacy of medicines. These are set out below and on
the following pages.
The 14th ICDRA was hosted by the Health Sciences Authority of Singapore in collaboration with the World Health Organization. The Conference continues to be a cornerstone of international harmonization of medicines regulation and ishighly appreciated
for the platform it provides in highlighting matters of urgency and relevance to an often
difficult but vital sector of the health care system.

ICDRA RECOMMENDATIONS
Improving drug regulation
as part of health systems
strengthening
Major trends relating to regulatory support
for medical products present medicines
agencies and WHO with numerous
challenges. Theincreasing complexity of
regulatory work — whether as a result of
new technologies, globalization of commercial activities or internationalization of
product development — is particularly
onerous.
Increasing autonomy of management and
decision-making in governmental regulatory systems, together with greater
interaction between regulators and the
private sector in the development of
standards...