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FMD

Medicines recalled after FMD alert

The MHRA has warned patients that batches of drugs for Parkinson’s, epilepsy and blood clots have been taken out of the legitimate supply chain during distribution and later reintroduced and given to patients.

British regulators are enacting a recall of the drugs Neupro, Vimpat, and Clexane after it was found that certain batches of the drugs had been removed from the supply chain and relabelled with B&S Healthcare labels.

Top Ten most popular articles on Pharmafile.com this week!

News that the FDA’s advisory panel had recommended Janssen’s intranasal esketamine spray Spravato as a treatment for treatment resistant depression, took the top spot this week. The therapy, based on party drug ketamine, may act as a significant breakthrough in the neglected area of mental health.

Other news saw England’s chief medical officer Dame Sally Davies, who is leaving her current role to become Master of trinity College Cambridge, suggest that as many as one third of antibiotics may be prescribed inappropriately.

FMD would not apply in case of no-deal Brexit

The Falsified Medicines Directive would be scrapped in the event of a no deal Brexit, the Association of the British Pharmaceutical Industry (ABPI) has warned. The scrapping of the EU legislation could put patients at risk.

API imports in the EU: gauging the FMD’s impact

Published on 09/12/13 at 08:29am
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The deaths of dozens of patients as a result of the contaminated heparin incident in 2008 casts a long shadow over pharma to this day but - seven years on - new EU regulations are trying to ensure the tragedy will not be repeated. 

The heparin scandal was arguably one of the key drivers for the eventual passage in 2011 of the Falsified Medicines Directive (FMD), which is seeking to protect the medicines supply chain from infiltration by from counterfeit products, illicit substances and adulterated active pharmaceutical ingredients (APIs).

Switzerland first to pass EU's 'equivalence' test for APIs

Switzerland has become the first country to be classed as having equivalent standards for the manufacture of active pharmaceutical ingredients (APIs) under new EU rules.

The white listing of Switzerland among countries with equivalent API standards allows it to sidestep the new and controversial requirement - introduced via last year's falsified medicines directive (FMD) - of written confirmation that APIs imported into the EU meet appropriate standards.

EFCG calls for mandatory inspection of API plants

The European Fine Chemicals Group (EFCG) has called for all active pharmaceutical ingredient (API) manufacturing facilities to undergo mandatory inspections.

The trade organisation also wants national regulatory authorities to develop a mutual recognition agreement so agencies can "share scarce inspection resources and to avoid the present duplication".

The measures proposed by the EU Falsified Medicines Directive do not go far enough to ensure "the quality of APIs and medicines containing them meet the high standard recognised by developed economies", it says.

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