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[e-drug] WHO Drug Information, Issue 1 of 2018 published

E-DRUG: WHO Drug Information, Issue 1 of 2018 published

Dear e-drug members,
We are pleased to let you know that WHO Drug Information, Issue 1 of 2018  has 
been published on the WHO website 

Happy reading!
The first issue for 2018 includes featured articles on the following topics: 

Quality Monitoring

Product information supplied with selected antiretrovirals in five African 
As part of a WHO quality monitoring study on selected antiretrovirals (ARVs) in 
five African countries, the product information supplied with 107 samples was 
compared with that shown in the respective WHO Public Assessment Report 
(WHOPAR) (for prequalified products) or publicly available information for the 
innovator product (for non-prequalified products). 

Deviations, some of them potentially impacting on patient safety, were found 
for most of the samples. It is recommended that regulators, procurers, health 
professionals and patients make more use of the) to verify that the product 
information supplied with prequalified medicines conforms to that accepted by 

Safety of medicines
Pharmacovigilance Programme of India
This article describes the Pharmacovigilance Programme of India (PvPI). 

Recent changes in the regulation of the drug approval processes and pre- and 
post-approval vigilance of undesired effects have strengthened the 
pharmacovigilance platform in India. 

This article gives an overview of its structures and activities, their 
integration into public health programmes, the regulatory context, recent 
initiatives undertaken by PvPI, challenges to overcome, and the way forward.

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. 

The Regulatory news section gives an overview of developments at regulatory 
authorities, topics under discussion through public consultations, and 
approvals of products. 

This is followed by a section on Publications and events related to access, 
quality and use of medical products in WHO Member States.
The Consultation documents section includes draft monographs on Moxifloxacin 
hydrochloride, Moxifloxacin tablets, Clindamycin palmitate hydrochloride, 
Clindamycin palmitate powder for oral solution, Amoxicillin trihydrate, 
Clavulanate potassium, and Amoxicillin and clavulanic acid tablets, as well as 
a revised chapter on the Dissolution test for solid oral dosage forms, proposed 
for inclusion in The International Pharmacopoeia. 

These and other working documents are available for comment at: 
Issue 1 concludes with List No. 79 of recommended International Nonproprietary 
Names for Pharmaceutical Substances (INN).
Monika Zweygarth
 WHO Essential Medicines and Health Products (EMP)
ZWEYGARTH, Monika <zweygarthm@who.int>
Alternative e-mail: zweygarthm.gmail.com

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