by Kazeem Olalekan MRPharmS

There is no better time than the present to start putting forward the list of the changes we will like to see at the MHRA. MHRA is making valuable contribution to the safety of medicines and devices in the UK although its work has sometimes been constrained by the regulatory framework in Europe. I am not saying this because of any euro-sceptic tendencies but because of the example I eluded to in September last year where I expressed by my concern and disappointment at GSK’s response on Avandia (1). When the UK regulators are unanimous on a particular issue, why are they constrained to act because of timing of decision making elsewhere? Harmonisation of decision making is clearly needed.

My long standing gripe about Packaging is still there (2). Why is the MHRA focusing too much attention on this? It seems trivial and well…not green!

Whilst I disagreed with the criticism of the MHRA by Mr Mel Braham (3), the editorial in the Lancet about lesson from the USA (4) may offer a way forward with regards to how the regulation of medical devices should change in the future. Professor Toft of Coventry University also identified that the EU regulatory framework is not fit for purpose (5). The MHRA according to professor Toft, does not have the power to do the things they have to do pro-actively. The comments by the good professor is worth listening to.

There are other suggestion on the configuration of the MHRA that is definitely worth listening to: They are joint comments by my professional body and other pharmacy organisations (6). They revolve around the following:

  1. Cost of implementing a single set of regulation
  2. Future guidance
  3. Removing prepared medicines
  4. Abolishing fluted bottles
  5. Statutory warning for medicines
  6. Obsolete exemptions
  7. Universities and research institutions
  8. Patient group directions
  9. Optimisation of Medicines

The statement is comprehensive and include a number of other changes which Royal Pharmaceutical Society will like to see.

So there is no better time than the present for the MHRA to intensify its effort to address all of these issues. I am sure the organisation is doing just that.

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