WHO Drug Information
Volume 31, N° 2, 2017
The second issue for 2017 includes featured articles on the following topics:
- Regulating medicine manufacturers: is an on-site inspection the only option?
A risk- and reliance-based approach to inspection planning is essential for effective regulatory oversight of pharmaceutical manufacturing and testing sites, including those located outside the regulatory authorities’ territories. This paper describes the pathways used by the Australian Department of Health’s Therapeutic Goods Administration (TGA) for granting good manufacturing practice (GMP) clearance.
- Placebo and drug kits in clinical trial design
Good quality clinical trials are key in bringing new safe and effective medicines to patients. This paper summarizes some published information on two specific aspects of conducting clinical studies, namely the use of placebo as a control intervention and the use of drug kits for effective blinding of trials.
- Survey of the quality of selected antiretroviral medicines (ARVs) circulating in five African countries
An ARV sample testing survey was organized by WHO in 2015/16 as part of its quality monitoring activities for medicines. This article presents an overview of the findings. The survey confirmed the positive impact of WHO prequalification in assuring the quality of ARVs used in HIV treatment programmes of WHO Member States. A full report of the survey is in preparation.
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 presents proposed texts for The International Pharmacopoeia, including draft monographs on mebendazole tablets, atenolol, capreomycin sulfate, capreomycin for injection; a concept paper for the transition from microbiological to physicochemical assays in monographs on capreomycin active pharmaceutical ingredients and products; and a proposed text on capillary electrophoresis. A list is also provided of medicines quality guidelines that were recently posted for public comment.
The ATC/DDD classification section presents the temporary and final lists intended for the January 2018 version of the ATC/DDD Index. Comments or objections regarding the temporary list should be forwarded to the WHO Collaborating Centre for Drug Statistics Methodology before 1 September 2017.
Issue 2 concludes withList No. 117 of proposed International Nonproprietary Names for Pharmaceutical Substances (INN). Comments or objections may be forwarded to the INN Programme within four months of the date of their publication in WHO Drug Information.