The Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new framework to authorise medicines and bring new drugs to patients in the UK.
The International Recognition Procedure (IRP) will provide UK patients with access to safe and effective medicines that have been approved by trusted regulatory partners.
Developed by the MHRA, the IRP, which was implemented on 1 January, allows the agency to consider the expertise of other trusted regulatory partners in other countries.
The new international recognition route for medicines will utilise pre-existing approvals from other countries, including Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.
Additionally, the MHRA will partner with regulators in those countries, as well as the European Medicines Agency, individual EU member states and the European Economic Area.
The MHRA has expressed that it “retains ultimate authority to accept or reject applications submitted under the IRP”. The international IRP process is “designed to result in a more rapid, efficient and cost-effective process for applicants”.
The IRP will be used for multiple types of marketing authorisation applications (MAAs) according to the Human Medicines Regulations 2012, including chemical and biological new active substances and known active substances.
According to the Association of the British Pharmaceutical Industry, the IRP offers regulatory flexibilities for drugmakers to consider when applying for their products to enter the UK market.
New applicants under the IRP include two routes, A and B, which have the time available to review authorisations determined at 60 and 110 days – significantly shorter than the current 150-day target for applications.
Health minister Andrew Stephenson said that the IRP “shows how organisations can maximise Brexit freedoms, accelerating patient access to new medicines on the NHS and putting the UK on the forefront of medical innovation”.
The launch of the framework follows the UK’s departure from the European Commission’s Decision Reliance Procedure, which ended on 31 December last year.
In addition to this, to further streamline the IRP, the MHRA launched an Eligibility Checker tool in November last year for applicants to utilise six weeks prior to making a full submission to determine whether their MAA is suitable and to identify which route to follow.