MHRA kicks off new accelerated drug approval pathway with ‘innovation passports’
As the UK no longer participates in the European Medicines Agency, the country’s drug regulator is getting creative in trying to attract top biopharma companies to submit applications to the EU and UK separately.
As part of this creative push, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s standalone medicines and medical devices regulator, last week unveiled a new accelerated drug approval pathway, known as the Innovative Licensing and Access Pathway (ILAP).
Drugmakers interested in the ILAP must first complete an “Innovation Passport” application (not be confused with the promising innovative medicine (PIM) designation) to explain how the condition to be treated is life-threatening or whether there’s a significant public health need.
Drugs that might qualify for this “Innovation Passport,” which comes with a £3,624 ($5,038) fee, include those that are new chemical entities, advanced therapies, drugs for rare diseases or special populations, or in development “in a clinically significant new indication,” MHRA says. In addition, sponsors must explain how patients are likely to benefit from the new product or indication either via data from valid non-clinical models or, if justified, extrapolated from another relevant model.
Similar to the WHO’s target product profile, a product-specific team of experts at the MHRA will then help define the target development profile (TDP) for the drug, for a fee of £4,451 ($6,187), based on each drug’s characteristics. Drug developers can hold a meeting on the TDP, which can be scheduled after a positive outcome on the Innovation Passport designation.
After the TDP meeting (multiple meetings may be necessary), MHRA said it will develop a TDP roadmap, which will be sent to drug developers in 4 to 6 weeks, unless otherwise agreed.
“The TDP will include details about how you can work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations. It is expected that the TDP is a living document, updated along the development programme timelines and milestones as new knowledge is generated,” the MHRA explains.
Overall, the MHRA says the ILAP provides drug developers with opportunities for enhanced regulatory and other stakeholder input. “Horizon scanning and regulatory science will make sure the pathway is at the forefront of cutting-edge developments and has the framework to develop evidence-based practice as new technologies and methods emerge,” MHRA adds.