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
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
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).