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WHO Drug Information Vol. 24, No. 4, 2010

WHO Drug Information Vol. 24, No. 4, 2010

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<strong>WHO</strong> <strong>Drug</strong> <strong>Information</strong> <strong>Vol</strong>. <strong>24</strong>, <strong>No</strong>. 4, <strong>2010</strong>Recent Publications, <strong>Information</strong> and Eventsand 2009, only 38.8% of patients enrolledin pivotal clinical trials, received theirtreatments at clinical trial sites within theEU and EEA. These trials involved morethan 44 000 clinical trial sites in 89countries. The data generated was usedto support 347 marketing authorizationapplications as well as some applicationsfor a variation or a line extension of theexisting marketing authorization.References1. Draft Reflection Paper on Ethical and GoodClinical Practice (GCP) Aspects of ClinicalTrials of Medicinal Products for Human UseConducted in Third Countries and submitted inMarketing Authorization Applications to theEuropean Medicines Agency, at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/<strong>2010</strong>/06/WC500091530.pdf2. EMA Press Release, EMA/559074/<strong>2010</strong>, 6September <strong>2010</strong> at http:// www.ema.europa.euEvaluation of futurenanomedicinesEuropean Union — The EuropeanMedicines Agency (EMA) has hosted thefirst international scientific workshop onnanomedicines in September <strong>2010</strong>.Some 200 European and internationalparticipants from 27 countries includingAustralia, Canada, India, Japan and theUnited States discussed benefits andchallenges arising from the application ofnanotechnologies to medicines. Participantsincluded representatives frompatient organizations, health care professionalorganizations, academia, regulatoryauthorities and the pharmaceuticalindustry.Nanotechnologies have a wide and stillonly partially exploited potential in thedevelopment of medicines. They providescope for engineered nano-systems thatcould lead to a spectrum of useful functionssuch as refined drug delivery,advanced combined diagnostics/therapeuticfunctions, matrices and supportstructures for regenerative medicines.Some eighteen marketing authorizationapplications for nanomedicines havebeen reviewed by the EMA so far.Emerging therapies give rise to questionson the appropriateness of current regulatoryframeworks, the relevance andadequacy of existing requirements andguidelines, and on the availability ofadequate expertise to regulators. Scientificchallenges arise from the limitationsof current testing methods and thereliability of novel ones, because of the‘nanosize’ and the unique behaviour ofsuch nano-systems in biological structures.Reference: European public assessmentreports for nanomedicines and presentationsof the keynote speakers at the workshop(EMA/567306/<strong>2010</strong>) at: http://www.ema.europa.euReporting on opioidinaccessibilityStrong opioids such as morphine arerarely accessible in low- and middleincomecountries, even for patients withthe most severe pain. The three casesrecently reported in the Journal of Painand Palliative Care Pharmacotherapyfrom three diverse countries provideexamples of the terrible and unnecessarysuffering that occurs everyday when thisessential, inexpensive, and safe medicationis not adequately accessible bypatients in pain. The reasons for this lackof accessibility are explored, and ways toresolve the problem are proposed.Reference: Krakauer EL, Wenk R, Buitrago R,Jenkins P, and Scholten W . Opioid inaccessibilityand its human consequences: ReportsFrom the Field. Journal of Pain and PalliativeCare Pharmacotherapy, <strong>2010</strong>;<strong>24</strong>(3):239–<strong>24</strong>3.311

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