E-DRUG: WHO Drug Information Issue 2 of 2016 published
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Dear e-drug members,
The latest issue of WHO Drug Information (Vol. 30 No. 2) has just been
published on the WHO website and is freely available here:
http://www.who.int/medicines/publications/druginformation/issues/DrugInformation2016_Vol30-2/en/
.
WHO Drug Information provides an overview of topics of current relevance
relating to drug development and regulation. The second issue for 2016
includes featured articles on the following topics:
--ICDRA: This article looks at the past and present achievements of the
biennial International Conference of Drug Regulatory Authorities (ICDRA) in
the lead-up to the 17th ICDRA in November 2016, which will be the first
ICDRA to take place in sub-Saharan Africa.
--Quality testing of vaccines: The WHO Prequalification Team reports on the
identification of a harmonized test method to determine the content of
Haemophilus influenzae B (Hib) component in any WHO-prequalified liquid
combination vaccine containing a whole-cell pertussis component. Hands-on
training courses on implementation of this time-saving method have been
organized for quality control laboratory technicians from 13 countries.
--Medicines shortages: This article presents a summary and outcomes of a
WHO-convened technical consultation on shortages of essential medicines.
This problem has received increasing attention in recent years and has been
discussed as a specific topic for the first time at this year?s World
Health Assembly.
--Concept paper for discussion: Contributed by the United Nations
Industrial Development Organization (UNIDO), this discussion paper proposes
a risk-based, phased roadmap towards WHO GMP for the manufacture of
finished pharmaceutical products in low- and middle-income countries.
Comments are invited and should be sent to druginfo@who.int.
The Safety news section highlights information on adverse drug reactions
and recommendations including labelling changes, as well as findings of
non-compliance with good practices and falsified product alerts. The
Regulatory news section gives an overview of developments at regulatory
authorities - particularly those having an impact on decision-making and
risk assessment - as well as approvals of products. This is followed by a
news section on Publications and events related to the quality and use of
medical products in WHO Member States.
The Consultation documents section includes a proposed Revision of Chapter
2.6, Non-aqueous titration for The International Pharmacopoeia.
The ATC/DDD classification section presents temporary and final lists for
the January 2017 version of the ATC/DDD Index, the repository of Anatomical
Therapeutic Chemical (ATC) codes and Defined Daily Doses (DDD) used widely
for exchanging and comparing data in national and international drug
utilization research.
The issue concludes with List No. 115 of proposed International
Nonproprietary Names (INN).
Best regards,
Monika
Monika Zweygarth
WHO Essential Medicines and Health Products (EMP)
Alternative e-mail: zweygarthm.gmail.com