MRHA launch new pathway to speed up approval of innovative medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new initiative to speed up the time it takes to get innovative medicines to market.
The MHRA says the Innovative Licensing and Access Pathway (ILAP) will provide a “single integrated platform” for collaborative working between the agency, partners and the medicine developer.
The ‘Innovation Passport,’ a new medicine designation, will act as a gateway to the pathway and will be awarded to innovative products submitted to the ILAP.
The passport will allow the ILAP to encompass a wide range of medicines undergoing development, including Advanced Therapy Medicinal Products, medicines for rare diseases and repurposed medicines.
“Pharmaceutical companies will be offered a rolling review, as was done with the Pfizer/BioNTech vaccine.” ABPI Chief Executive Richard Torbett
A successful Innovation Passport designation leads to the creation of a Target Development Profile. The MRHA says this will “set out a unique, product-specific roadmap towards patient access in the UK healthcare system”.
This will include access to tools that can be used to design an efficient and “regulation and access-ready” development programme.
Commenting on the announcement Lord Bethell, Minister for Innovation, said: “We are absolutely determined to make sure UK patients can access the latest cutting-edge medicines as quickly as possible.”
Dr June Raine, Chief Executive of the MHRA, added: “We are transforming the MHRA, making the regulator an enabler of innovation.
“Our new ILAP has established new partnerships to robustly and safely support all new medicines at any point in their development. And most important of all, involve patients in all aspects of decision-making.”
The new initiative was also welcomed by the Association of the British Pharmaceutical Industry.
ABPI Chief Executive Richard Torbett said: “It is really encouraging to see the MHRA launch a new Innovative Licensing and Access Pathway which will help our companies get new treatments to patients faster.
“This will be achieved by offering them a similar rolling review as was done with the Pfizer/BioNTech vaccine and concurrent review by all parts of the health system.
“This is something we’ve been calling for as the MHRA prepared for Brexit.”
Further information about the ILAP application process can be found here