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Last week’s round-up, 10-14 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


NDMA in Metformin: FDA Finds Low Levels in Only 2 of 10 Tested Products

14 February 2020

The FDA has tested several Metformin drug product and active substance samples for the potentially carcinogenic impurity NDMA.

Most of the metformin drug product samples did not show any detectable levels of the impurity, while some samples showed low levels of NDMA. The impurity was not detected in any of the metformin active substance samples tested.

Based on these results, the FDA has not issued any recalls of the product and has advised that diabetic patients should continue to take their metformin medications.

The FDA has also advised that it will be publishing the analytical methods used in metformin testing in due course.

What Happens To The FMD In the UK After Brexit Day?

13 February 2020

Post Brexit the fate of the Falsified Medicines Directive (FMD) in the UK remains uncertain.

Until the end of the implementation period at the end of the year, the UK will remain aligned to EU law. Therefore, the FMD will continue to apply and the associated UK medicines verification organisation and system (SecurMed) will remain connected to the European Medicines Verification System (EMVS). Negotiations between the EU and UK will determine what will happen to the UK FMD systems following the implementation period.

European Pharmacopoeia welcomes its 39th member state, Albania

12 February 2020

Albania has joined the European Pharmacopoeia as a member state.

Quality standards for medicines published in the Ph. Eur. are now legally binding throughout the country. This brings the total membership to 39 European countries and the European Union, together with 29 international observers:

EU Regulatory Roundup: US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs

11 February 2020

The US Embassy in the Netherlands has raised the alarm about the Dutch government’s policies on the compounding of patented drugs.

The legislation has not been well received by the embassy, which stated that “such policies send a clear message to companies that IPR in the Netherlands can be undermined or circumvented for short-term financial benefits. Such regulatory change could allow patented medicines to simply be replaced by a cheaper, non-patented copy.” However, the US Embassy has also reiterated that it is willing to work with the Dutch government to address the issue.

Among other topics discussed in the linked roundup article: a Nitrosamine testing guide created by the Spanish Agency of Medicines and Medical Devices (AEMPS), the new drug shortage regulation adopted in Belgium, the disruption of work at the Dutch Medicines Evaluation Board (MEB) due to technical issues, an update on the MHRA yearly fees, the raising of the EU flags at the new EMA headquarters and the switch to electronic signatures at Fimea.


Image: Albanian Flag, CC BY-SA 2.0

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