The UK's medicines regulator 'the MHRA' rightly has a strong and positive reputation amongst its peers in the EU for its contribution and scientific expertise. Indeed, it delivers the largest share of the work in reviewing applications for pan-European marketing authorisations, of which the generic sector is the biggest user.
In the key area of new product registrations, BGMA has been closely surveying MHRA performance year on year and identifying areas requiring improvement, for discussion with the regulator. This has resulted in major improvement in the time taken for new generic medicines to be registered in the UK. This is greatly assisting the predictable timely availability of generic medicines for patients, healthcare professionals and has also resulted in NHS cost savings.
In other areas of regulation, such as changes to existing approved medicines and transferring licences, there is still a need for MHRA to focus and improve, particularly on the time taken to reach decisions.
With the increasing weight of new legislation coming from Europe, the BGMA continues to work closely with MHRA to ensure its drafting and UK implementation is well managed, and minimises red tape and over regulation. This safeguards the sustainability of the NHS, so that affordable generic medicines are quickly available to patients, allowing the NHS to afford other treatments and expensive innovative medicines for unmet clinical needs.