PharmExec Blog

European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. T

he new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate mainly to the reporting of adverse drug reactions (ADRs) for the detection of safety and efficacy defects. They also cover quality problems such as deficiencies in manufacturing, inadequacies in formulations, including excipients, as well as faulty drug-delivery technologies.

EMA claims that the new pharmacovigilance legislation, implemented in mid-2012 in both the EU and the two non-EU countries of Norway and Iceland, has “brought about the biggest change to the legal framework for human medicines” in Europe since the creation of the central agency itself in 1995. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has already “made great strides towards a new era in protecting public health,” according to its chair June Raine.

Nevertheless, as the pharmacovigilance infrastructure gradually becomes more entrenched in Europe, drug manufacturers and other marketing authorization holders (MAHs) are complaining that they are shouldering an unfair proportion of its high costs.

For more on this Pharm Tech article by Sean Milmo, click here.

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Biopharma's Top Offshore Destinations

Biopharmaceutical manufacturing is following the general pharmaceutical market trend toward global expansion.

BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production identifies the markets best poised to profit from the internationalization of the outsourcing, finding that emerging markets such as China and India are among top potential destinations for both US and Western European companies.

As part of the study, respondents were asked to consider their five-year time horizon (lead-up to 2019) and to evaluate their facility’s current plans for future international capacity expansion (not domestic).

More than 25 countries as potential outsourcing destinations, and geographic proximity is no longer seen as a critical factor in the partner selection process.

For more on this Pharm Tech article by Eric Langer, click here.

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BMS and Merck Race to Melanoma Treatment Market

Merck’s Keytruda, recently approved in the US to treat patients with advanced melanoma that have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo,  an analyst from research and consulting firm GlobalData has reported. Read More »

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EFPIA Efforts to Block Stolen Drugs in European Supply Chain

The European Federation of Pharmaceutical Industries and Associations’ new medicines verification system will put an end to the re-sale of stolen and counterfeit drugs in the European supply chain, the organisation claims.

The European Stakeholder Model (ESM) reportedly offers a cost-effective technological solution using anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products.

Because of loopholes in traceability systems across EU jurisdictions,  stolen medicines are re-entering the legal trade in EU countries through fictitious or corrupt brokers. With EFPIA’s verification system, serial numbers corresponding to each packaging will be recorded in the system; in case of repackaging, a link between the originators’ serial numbers and the traders’ serial numbers at batch level will be secured in the system. This link, reports EFPIA,  will prevent any re-introduction of stolen medicines on any EU markets.

Last week AIFA, the Italian Medicines Agency, reported that between 2006 and 2013 one in ten Italian hospitals registered thefts of pharmaceuticals.


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Sunny Outlook for Outsourcing

Early-stage and mid-size bio/pharmaceutical companies have enjoyed an embarrassment of riches over the past 18 months. The window for initial public offerings (IPOs) re-opened, at least for a while. Global bio/pharmaceutical companies continued their frenzied pace of partnering and acquisition activity, and venture capital spiked up as the prospects improved for rich exits.

The results of the 2014 edition of the PharmSource/Pharmaceutical Technology Outsourcing Survey show that strong growth is continuing. See Jim Miller’s Pharmaceutical Technology article here.

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