News about GMP/cGMP
On October 4, the British MHRA (Medicines and Healthcare products Regulatory Agency) has launched a public consultation seeking views on how the agency’s legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period. This consultation covers no-deal proposals on medicines, clinical trials and medical devices.
As already reported, a no-deal-Brexit is not what the MHRA wishes for. It is believed to be in the interests of both the EU and the UK to strike a deal. That is stated to be the goal on both sides and the MHRA is confident that this will be achieved.
In case of a “no-deal Brexit” the overall approach for the MHRA is to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.
The ABPI (Association of the British Pharmaceutical Industry) has already responded on its website, saying that the proposal will be studied in detail and a response will be submitted in due course. Deputy Chief Officer Dr S. Porkess also stated:
“… We have been very clear that the best way to protect patients and public health in the UK and in the EU is to agree future cooperation between the MHRA and the EMA on the regulation of medicines”, and “… we continue to urge both the UK and EU negotiators to rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”
The public consultation will be closed on November 1, 2018.