- All > Medicine Information and Evidence for Policy > Information and Publications
- All > Quality and Safety: Medicines > International Nonproprietary Names
- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- All > Quality and Safety: Medicines > The International Pharmacopoeia
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > efficacy
- Keywords > EU medicines regulation
- Keywords > International Nonproprietary Names (INN)
- Keywords > International Pharmacopoeia (The)
- Keywords > medicines regulatory authority (MRA)
- Keywords > regulation
- Keywords > regulatory assessment
- Keywords > regulatory information
- Keywords > regulatory matters
- Keywords > safety
(2011; 125 pages)
This fourth issue for 2011 opens with Seven years of EU pharmaceutical regulation in Malta a Regulatory Focus article which describes the overarching principles of EU medicines regulation and how, since 2004, Malta has achieved integration as a Reference Member State through participation in different EU regulatory mechanisms, such as mutual recognition and the decentralized procedure.
The section on International Harmonization highlights an article from Swissmedic, the Swiss Agency for Therapeutic Products, Integration and application of equivalent regulatory assessments from other countries which responds to a recommendation made during the Fourteenth International Conference of Drug Regulatory Authorities held in Singapore in 2010 when regulators operating schemes that openly and transparently utilize data from other countries were requested to document their processes and experiences as a resource for use by other countries.
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.
Consultation Documents concerning the International Pharmacopoeia cover revision of General Methods in the 4th Edition: bulk density and tapped density of powders, tablet friability, test for bacterial endotoxins, test for sterility. This is followed by revised monographs for chewable albendazole tablets, artenimol, medroxyprogesterone injection, and ritonavir tablets.
The journal concludes with the 106th Proposed List of International Nonproprietary Names (INN).