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- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- All > Quality and Safety: Medicines > The International Pharmacopoeia
- All > Prequalification of Medicines > WHO-UNICEF-UN Project
- Keywords > adverse drug reactions
- Keywords > ATC/DDD Classification
- Keywords > efficacy
- Keywords > International Nonproprietary Names (INN)
- Keywords > medicines for children
- Keywords > paediatric medicines
- Keywords > pharmacovigilance
- Keywords > quality assurance
- Keywords > regulatory matters
- Keywords > safety
- Keywords > medicamentos pediátricos
(2012; 96 pages)
Our first issue for 2012 opens with an article in the Regulatory Focus series, "Regulation of medicines in China". This provides insight into changes taking place in the organizational structure, legislative framework and current situation of medicines regulation in China with a focus on medicines registration, use, advertising and post-market safety monitoring as well as control of narcotics and psychotropic substances. It also draws a picture of China’s pharmaceutical industry and offers a glimpse of the transformations taking place in the national medicines regulatory scene set against a backdrop of international harmonization.
The section on Paediatric Medicines highlights the need for better medicines for children and specifically, the work currently under way to provide paediatric pharmaceutical formulations to suit the age, physiological condition and body size of the child. Use of unlicensed and off-label medicines in children is widespread. A WHO guideline “Development of paediatric medicines: points to consider in pharmaceutical formulation” has now been published following adoption by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
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 is complemented by the section on 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 final and temporary lists of ATC/DDD Classifications adopted by the WHO International Working Group for Drug Statistics Methodology are also presented.
The final section, Recent Publications, Information and Events, provides brief summaries of several recently-published documents and online resources.
The journal concludes with the 67th Recommended List of International Nonproprietary Names (INN).