Framing the argument

The European debate about combating counterfeit medicines is generating a lot of heat in Brussels as it comes to a head. In March the European Parliament is starting to tackle the detail of the European Commission’s proposal to stop falsified products getting into the legal supply chain – about the same time as officials from the EU member countries are nearing some sort of view on the technicalities. Read more »

US and Europe At Risk from Substandard Medicines

When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually be dangerous. Recently, the public and policymakers have become more aware of the issue of counterfeit medicines — especially as patients increasingly learn about how to shop safely online for pharmaceuticals. But scant attention has been paid to a safety issue that is also important to patients — the problem of substandard medicines. Read more »

Regulatory Affairs: Challenges for 2010

Julian Upton Pharm Exec EuropeThe Organization for Professionals in Regulatory Affairs (TOPRA) is a non-profit, non-political organization that seeks to advance the status of the regulatory profession through education and the provision of information to its members. Its members are drawn from industry, regulatory agencies and consultancies from over 40 countries. Pharm. Exec. Europe (PEE) spoke to TOPRA’s president-elect, Dr Zubair Hussain, head of regulatory affairs for Pfizer UK and Ireland, about what he sees as pharma’s key regulatory challenges for 2010 and beyond. Read more »

Sanctions, Not Barcodes

Corrine Lawrence PharmTech Europe editorTechnology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

USP and USAID Launch New Program to Improve Drug Quality

Alexis Brekke Pellek PharmTech editorThe US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

Barcodes Fight the Counterfeit Threat

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

Recent Announcements in Anticounterfeiting Technology

Alexis Brekke Pellek PharmTech editorThis week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

Report: Online Drug Brand Abuse on the Rise

Alexis Brekke Pellek PharmTech editorPharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »

Securing the Global Supply Chain: FDA’s or Industry’s Responsibility?

danmatlisAt a joint session of the PharmTech Conference and the 4th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security OversightThe globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »

New Report Focuses on Yahoo’s Rogue Pharmacy Advertisers

Alexis Brekke Pellek PharmTech editorLike the recent report on Microsoft Bing’s sponsored ads for online pharmacies, a new report released this week by Internet-pharmacy verification organization LegitScript and antispam firm KnujOn focuses on the legitimacy of online pharmacies advertising in sponsored links on Yahoo.com. Read more »

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