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Euro Roundup: MHRA sheds light on pathway to accelerate R&D

Posted 24 December 2020 | By Nick Paul Taylor 

Euro Roundup: MHRA sheds light on pathway to accelerate R&D

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Innovative Licensing and Access Pathway (ILAP) it is setting up to accelerate time to market. Drug developers that follow the pathway will benefit from more input from MHRA and stakeholders including the National Institute for Health and Care Excellence.
 
Drug developers can access the pathway as soon as they have nonclinical data on a new chemical entity, biological medicine, new indication or repurposed molecule, although the scheme also permits entry once a candidate is somewhat closer to market. MHRA is encouraging companies to apply early in development to maximize the benefits. The pathway is “generally not suitable” for candidates that “are towards the end” of development, MHRA said.
 
Companies that want to use ILAP first need to apply for an Innovation Passport, which incurs a fee of £3,624 ($4.934). To meet passport  criteria on product characteristics, a candidate must either be an innovative medicine, such as an advanced therapy medicinal product, target a clinically significant new indication or niche population, or align with the objectives of UK public health priorities.  
 
The characteristics of the product will inform the target development profile (TDP). By creating and continuing to update the TDP, MHRA aims to identify potential pitfalls and opportunities for the drug developer to work with UK stakeholders, all with the goal of accelerating patient access.
 
UK officials have created application tools to support ILAP. For example, MHRA has established an adaptive inspections tool that will feature “live-phase inspections for pre-clinical or clinical aspects, ensuring design and technologies are fit for purpose and appropriate manufacturing licences are in place in line with statutory requirements.”
 
MHRA will operate ILAP alongside its existing Early Access to Medicines Scheme (EAMS). The agency said ILAP “is broader in scope and is open to all innovative products.” EAMS will continue to support early patient access to products that address an unmet medical need and are nearing the end of the development process.
 
MHRA will publish application forms for ILAP on 1 January.
 
Guidance
 
EMA targets December 2021 go-live date for Clinical Trials Information System
 
The European Medicines Agency (EMA) is aiming to have its oft-delayed Clinical Trials Information System (CTIS) ready for use in December 2021, committing to the target in an update of its 2021 plans.
 
CTIS was originally due to launch in September 2018. However, the project has suffered a series of delays, pushing back the go-live date for CTIS and the implementation of the Clinical Trial Regulation it is designed to support. EMA and the developer reset expectations in March 2018 and months later embarked on an agile and iterative development strategy.
 
The strategy has put EMA in a position to aim to have the system ready for use in 12 months’ time. Between now and then, EMA plans to review the findings of a CTIS audit and improve the usability, quality and stability of the system. As the system nears real-world use, EMA will work to prepare users and their organizations for the implementation of CTIS.
 
The version that EMA makes available in December 2021, assuming it hits its target, might lack some of the features intended for the finished system. EMA is aiming to deliver a minimum viable product (MVP), a term for a product that has just enough features to satisfy early users. Organizations that deliver MVPs then gather feedback from users for future product development.
 
Exactly what features are needed for the MVP version of CTIS remains unclear. EMA said the CTIS program governance has responsibility for deciding on the minimum set of features needed to make the system available for users.
 
EMA Update
 
MHRA clarifies post-Brexit rules on location of pharmacovigilance leaders
 
MHRA has issued guidance on rules that will apply to marketing authorization holders (MAH) when the Brexit transition period ends.
 
MAHs will need to “permanently and continuously” have a Qualified Person responsible for Pharmacovigilance (QPPV) at their disposal from January who is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorized products.
 
MHRA will allow companies to base their QPPV anywhere in the UK or the European Economic Area (EEA). MAHs with QPPV based in the EEA need a national contact person for pharmacovigilance in the UK. European Union member states will not accept QPPV based in the UK.
 
The guidance also addresses the need for the holder of a UK marketing authorization to have a base in the UK or EEA. Again, EU member states will not accept a MAH located in the UK.
 
MHRA Notice

 

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