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- Keywords > ATC/DDD Classification
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- Keywords > International Nonproprietary Names (INN)
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- Keywords > quality risks of pharmaceutical products
- Keywords > regulatory assessment
- Keywords > safety and efficacy
- Keywords > WHO International Drug Monitoring Programme
(2012; 135 pages)
The final issue for 2012 opens with a set of recommendations made by regulators attending the 15th International Conference of Drug Regulatory Authorities (ICDRA) meeting in Estonia 23-26 October 2012. The ICDRA attracted a record number of participants from over 100 countries. The scope and diversity of topics included in the conference programme responded to major trends encountered in the operation of medicines regulatory agencies and particularly those issues having an impact on regulatory affairs in a globalized environment. This summary is followed with a brief report and recommendations from a two-day pre-ICDRA meeting entitled "Quality of medicines in a globalized world: focus on active pharmaceutical ingredients".
The WHO Programme on International Drug Monitoring presents an article outlining the strategy now being adopted for the future operation of the Programme. It focuses particularly on the challenges of low- and middle-income countries in setting up and operating a pharmacovigilance system to enhance efforts in assuring the safety of medicines, addressing the need for risk management, reducing the burden of irrational use of medicines, and identifying poor-quality medicines.
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.
Recent Publications, Information and Events, provides brief summaries of several recently-published documents and online resources. This is followed by a section containing the ATC/DDD Classification temporary and final lists.
The journal concludes with the 108th Proposed List of International Nonproprietary Names (INN).