CASAA’s take on the recent move by MHRA

For those who read this blog but not the main CASAA blog, you might be interested in our assessment of the UK MHRA’s move to require that e-cigarettes be approved as medicines.  You may find our analysis of what regulation by MHRA would look like to be somewhat more optimistic than what you might have read elsewhere.  However, we are rather more concerned than some other commentators about its implications for the EU.

2 responses to “CASAA’s take on the recent move by MHRA

  1. I was thinking along some similar lines yesterday reading through the various supporting docs on the MHRA site.

    There are some apparent, but not huge, concessions to full-on medicines regulation (large scale efficacy RCTs ‘might not’ be required for each application, but smaller clinical pharmacodynamic-type studies definitely would be). The MHRA are also obliged to comply with requirements of other EU medicines regulation, which mandate certain standards and inspections in the place of manufacture, which could be problematic for the current supply chain. The exact process for device variants, including stuff unique to e-cigs like flavourings, wasn’t clear, though I didn’t get an overwhelmingly positive reading from it.

    However, an interesting point was that in some of the ‘impact assessment’ type documentation, there was explicit acknowledgement that, if regulatory practice retarded the market enough to restricted availability and use – even by a relatively small amount – there was potential for large public health losses.

    If (barring things going a different way in Europe, or a legal challenge by existing vendors) we approach a 2016 deadline and there are only a handful of products licensed due to the high burdens set, there could be significant pressure to reappraise the process, lightening up on requirements. Really it will only become clear once the first applications start going in though.

  2. Jonathan Bagley

    The UK anti tobacco industry has finally shown its true colours. They care nothing about health. Discussing this issue seriously is pointless. MHRA medicine approval is funded by the Pharmaceutical Industry (see my comment below the article link below), whose gum and patches are now obselete. For details of the nonsense, read the Free Society article referred to here

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