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Counterfeiting
Counterfeit medicines are now being found with unnerving frequency, even in the legitimate supply chains of developed markets such as the US and Europe. For manufacturers, regulators and other healthcare stakeholders that raises many issues, including the threat to public safety, the need to improve supply chain security and corporate accountability.
Systech’s T&T system wins ‘top 10’ pharma customer in Brazil
26-May-2011 - A serialisation system developed by Systech International has been selected by a ‘top 10’ pharma client as a way of meeting Brazil’s Law 11.903 track and trace requirements.
FDA & USP extend relationship to modernise drug quality
10-May-2011 - The FDA and USP have expanded their collaboration to ensure the quality of medicines by modernising tests and standards.
Second draft of Excipact guidelines released for consultation
02-May-2011 - The second draft of Excipact, a set of certification standards for drug excipient producers being developed by the EFCG, FECC, IPEC and PQD, has been sent to industry stakeholders for...
US-wide track-and-trace called for to pre-empt state laws
20-Apr-2011 - Pharma, distributors and dispensers have all called for a single, US-wide track-and-trace standard that pre-empts state laws.
GSK introduces SMS service to combat Nigerian counterfeits
16-Mar-2011 - GlaxoSmithKline (GSK) has partnered with Nigeria's National Agency for Food and Drug Administration Control (NAFDAC) to provide a patient SMS verification service for its antibiotic, Ampiclox..
Handheld spectrometers improving drug Quality in Nigeria, says AEI
07-Mar-2011 - Efforts to detect fakes with handheld spectrometers appear to be having a positive impact on drug quality in Nigeria according to research by US think-tank the American Enterprise Institute (AEI).
European Parliament votes yes on falsified medicines directive
17-Feb-2011 - The European Parliament has approved the falsified medicines directive and described it as a “huge step” in efforts to protect patients.
Batch variation has implications for developing world
14-Feb-2011 - Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.
EDQM developing “live demo” of track & trace anti-counterfeiting tech
10-Feb-2011 - The European Directorate for the Quality of Medicines & HealthCare (EQDM) has begun Phase 2 of its “track & track” anti-counterfeiting strategy and is seeking manufacturer participation.
USP launches drug quality programme in sub-Saharan Africa
09-Feb-2011 - The United States Pharmacopeoia (USP) will help regulators in sub-Saharan Africa ensure drug quality in a new scheme designed to boost testing and analysis capacity.
Anti-counterfeiting rules will limit access to safe drugs; Oxfam
02-Feb-2011 - The EU and US are using substandard medicines as an excuse to tighten IP rules, boosting pharma profits while making it harder for the poor to access drugs, according to...
Medisafe developing barcode tech to tackle counterfeits
27-Jan-2011 - Medisafe 1 Technologies is to enter the pharma anti-counterfeiting sector through development of a barcode system.
Weak anti-counterfeiting slowing ASEAN harmonisation
26-Jan-2011 - Failure to reduce counterfeiting is one of a number of issues slowing healthcare regulation harmonisation in ASEAN.
Dramatic lack of planning harming pandemic preparation
25-Jan-2011 - There is a dramatic lack of planning for the production and distribution of medical pandemic countermeasures, according to an OECD report.
All Indian pharma exports to require barcodes from July
20-Jan-2011 - All Indian pharma exports will soon require barcodes on primary, secondary and tertiary packaging as part of anti-counterfeiting efforts.
Fairfield adds 3-in-1 scanner
18-Jan-2011 - Fairfield Group has introduced a scanner capable of reading 1D barcodes, Pharmacodes and 2D data matrices used on pharmaceutical packaging.
Legislation & resources needed as Croatia prepares to join EU
10-Jan-2011 - Legislation and resources are needed to support Croatian pharmaceutical regulators in preparation for accession to the European Union (EU).
EU & India resolve generic drug seizures dispute; reports
13-Dec-2010 - The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe on route to Africa and Latin America, according to reports.
PSM forms affiliate to tackle counterfeits in India
09-Dec-2010 - The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
Multiple strategies needed to beat counterfeiters
02-Dec-2010 - Only multiple anti-counterfeiting strategies are able to beat increasingly sophisticated criminals, according to a seminar on anti-counterfeiting at the recent AAPS trade event in New Orleans.
Counterfeit ACT poses malaria resistance risk
02-Dec-2010 - Counterfeit ACT could support the spread of drug resistant malaria strains from South-East Asia, where chloroquine first became ineffective, to sub-Saharan Africa.
Anti-counterfeiting held back by self-interest & politics
29-Nov-2010 - Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.
ACTA finalised amid claims it creates trade barriers
24-Nov-2010 - ACTA was finalised last week but controversies remain, with research warning it could “create significant barriers to international trade, especially in generic medicines”.
Industry, innovation & Viagra-stuffed teddies at AAPS
22-Nov-2010 - Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
Partnerships needed to beat public health counterfeit threat
17-Nov-2010 - Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the...
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