UK International Recognition Procedure promotes faster access to new medicines

From 1 January next year, the International Recognition Procedure (IRP) will take effect, giving pharmaceutical companies greater scope to enter the UK market on the basis of prior decisions made by regulators in other trusted jurisdictions.

Subject to fulfilling eligibility criteria, manufacturers will be able to rely on the IRP for fast-track marketing authorisation in the UK if the products have already been approved by regulators in Australia, Canada, Japan, Switzerland, Singapore and the US, or, in the context of the EU, where products have obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) – as is the case under the current EC Decision Reliance Procedure (ECDRP), which the IRP will replace.

Natalie Coan of Pinsent Masons, a specialist in life sciences regulation, said: “The intention behind the IRP is to get new medicines into the UK market faster, to the benefit of patients and industry. By allowing the assessments made by trusted regulatory partners to be relied upon, the UK is hoping to add capacity to its own regulatory regime, and in doing so enable the Medicines and Healthcare Regulatory Authority (MHRA) to respond faster to applications for UK marketing authorisations. The new system also allows the MHRA to maintain its position as a sovereign regulator.”

“For industry, the IRP should enhance the attractiveness of the UK as a market for new medicines and encourage product approvals and launches sooner. By providing predictable and reliable timeframes for the processing of applications through the IRP, the MHRA is also helping pharmaceutical companies to plan their product launches ahead of time with greater certainty,” Coan said.

“It is often the case that new medicines are launched in the US first, then Europe. The IRP positions the UK advantageously and should encourage pharmaceuticals companies to consider how they might launch products earlier in the UK on the strength of approvals obtained from ‘reference regulators’ – and the US Food and Drug Administration (FDA), in particular,” she added.

The IRP is open to a wide range of different medicinal products, including ‘active substances’, generics, biologics, biosimilars, and new fixed combination products. As well as for obtaining UK marketing authorisation for the first time, the IRP can be used for renewals and variations.

There are two ‘routes’ under the IRP.

‘Recognition A’, which provides for UK approval within 60 calendar days of application, is only open to products that have benefited from a reference regulator approval in the two years prior to application date.

‘Recognition B’, which provides for UK approval within 110 calendar days – subject to a ‘clock stop’ at day 70 to provide for resolution of any issues identified – is open to products approved by a reference regulator within the past 10 years.

A range of other eligibility criteria applies and is set out in guidance issued by the MHRA on the IRP. For example, to benefit from the Recognition A route, the same manufacturing process must apply to the product as that considered by the reference regulator.

A triage system has been provided for where pharmaceutical companies are unsure which of the routes their products can fall into.

Coan said: “Ahead of the IRP taking effect, pharmaceutical companies should consider which of their products could benefit from the new fast-track system – and which route they would fall under.”