Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

MHRA seeks feedback on making personalized medicines at the point of care
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.
 
In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distribution, POC moves production to within or very close to the healthcare site that is administering the medicine. Some cell therapies are high-profile examples of POC production, but MHRA has also seen blood products, medical gases and small molecules made close to the site of administration. MHRA is considering a new regulatory framework for POC products.
 
The proposed regulatory framework is designed to support “growth of an emergent pharmaceutical manufacturing and supply sector” that will complement the existing supply chain. MHRA is aiming to ensure equivalent levels of safety without putting unnecessary regulatory barriers on POC products.
 
In talking to stakeholders to develop the framework, MHRA identified challenges related to the short shelf life of many POC products, which necessitates local production and makes current methods for quality control testing and qualified person certification impossible. Additionally, while a traditional drug is typically made at three to five sites, POC drug production can involve hundreds of sites, presenting further challenges to conducting inspections and naming individual sites on marketing authorizations.
 
MHRA is proposing the “Control Site” concept as a solution to these challenges. The Control Site would be a physical location named on the marketing authorization application that would be responsible for overseeing all aspects of POC production activities, including the addition of new manufacturing sites.
 
The Control Site would maintain a POC Master File that MHRA would review to assess compliance with good manufacturing, clinical and pharmacovigilance practices. MHRA is proposing annual reporting linked to the routine re-inspection of the POC manufacturing system. The agency is planning regular, risk-based inspections of the Control Sites and selected manufacturing sites.
 
Before pushing ahead with the changes, MHRA wants to know if stakeholders agree with the need for a POC-specific framework and, if so, whether they concur with the proposed regulatory framework. The agency is also seeking feedback on whether to adapt or extend the proposed framework to cover home-based and modular manufacturing.
 
MHRA is accepting feedback until 23 September. If, as planned, the POC regulatory framework is made part of UK law, MHRA will develop supplementary guidelines covering the application process and other operational activities.
 
MHRA Notice, More
 
UK competition watchdog starts probe into quality of COVID-19 PCR tests
 
The UK Competition and Markets Authority (CMA) has begun investigating the price, reliability and quality of PCR-based COVID-19 travel tests in response to concerns about the services provided to consumers.
 
In recent weeks, UK newspapers have reported problems that suggested COVID-19 testing for travel is “close to collapse,” with photographs posted online showing swab drop-off boxes run by Randox overflowing with unprocessed kits. Travelers from countries on the UK’s green and amber lists need to have a PCR test on their second day after returning home.
 
Sajid Javid, the UK health secretary, responded to the concerns by asking CMA to consider looking into the matter. CMA is now exploring whether COVID-19 PCR test providers are breaching their obligations under consumer law, whether structural problems in the PCR market are affecting price or reliability, and whether there are immediate actions the government could take to improve the situation.
 
“We are also working closely with [the Department of Health and Social Care] to get the data we need to identify the cause of any wider problems in the PCR testing market, and to ground our advice on what action may be needed,” George Lusty, CMA senior director for consumer protection, said.
 
CMA Notice
 
Finland shares advice on substitutable medicines and price notifications
 
The Finnish Medicines Agency (Fimea) has shared information on substitutable medicines and the price notification procedure in collaboration with its counterparts at the Social Insurance Institution and Pharmaceuticals Pricing Board.
 
Prior to each quarter, Fimea publishes a list of substitutable medicinal products. Fimea is asking all marketing authorization holders to ensure that product information is up to date before each quarterly release. Marketing authorization holders have 7 days to submit any corrections and additions to Fimea.
 
Fimea’s guidance also states price notifications must be sent to the Social Insurance Institution, also known as Kela, “for any medicinal product for which notification is required under the reference price and generic substitution systems.” Notifications must be submitted at least 21 days before the first day of each quarter. The notifications inform price bands and reference prices.
 
Fimea said notifications must be submitted even if the price of a drug product is unchanged, and are also needed for non-reimbursable products. “This ensures that pharmacies’ price lists are accurate and up to date about all products included in the generic substitution and reference price systems,” Fimea wrote in its guidance.
 
Fimea Notice
 
Moderna wins conditional UK approval for COVID-19 vaccine in adolescents
 
Moderna has received UK conditional marketing authorization for its COVID-19 vaccine in people aged 12 to 17 years. The approval means two vaccines are now cleared for use in children in the UK, although neither is being used routinely in people younger than 16 years of age.
 
MHRA based its conditional authorization on the same US Phase 2/3 clinical trial data that Moderna has used to win approval in other markets, including Switzerland. The study found the tolerability of the vaccine is similar in adults and adolescents, with injection site pain, headache and fatigue being the most common adverse reactions.
 
Moderna’s Spikevax joins the Pfizer-BioNTech vaccine on the list of COVID-19 jabs approved for use in children in the UK. While other European countries are vaccinating children as young as 12 years, the UK only recently lowered the minimum age to 16 years. Younger children can only get vaccinated if they are at increased risk of serious COVID-19 disease or live with an immunosuppressed person.
 
MHRA Notice, More
 
EMA starts assessing use of Roche arthritis drug in severe COVID-19 patients
 
The European Medicines Agency (EMA) has begun evaluating the use of Roche’s arthritis drug RoActemra in hospitalized adults with severe COVID-19. Roche received emergency use authorization in the U.S. in the indication in June and a strong World Health Organization recommendation in July.
 
EMA’s Committee for Medicinal Products for Human Use will perform an accelerated assessment of data from four large randomized studies before deciding whether to extend the label for RoActemra in the EU. A decision is expected by mid-October, unless EMA needs additional information to finish its review.
 
Authorization in Europe could put more pressure on supplies of RoActemra, which is sold as Actemra in some markets. Australian authorities acted earlier this month to ensure people with rheumatoid arthritis and other non-COVID-19 indications treated by the drug can access the IL-6 inhibitor. Roche later said demand for Actemra is “well-over 400% of pre-COVID levels.”
 
EMA Notice
 
GMED receives notified body designation for IVDR
 
The French firm GMED announced that it has received notified body designation under the EU’s In Vitro Diagnostic Regulation (IVDR) effective 20 August, making it the sixth IVDR notified body.
 
The deadline for IVDR regulation to come into force is 26 May 2022; regulators and industry alike have long expressed concern at the dearth of notified bodies to complete conformity assessments in anticipation of that deadline.
 
Speaking at the 2020 RAPS Euro Convergence, an officer at Ireland’s National Standards Authority pointed out that the role of the notified body is even more central to IVDR implementation than it has been for the coming into force of the Medical Device Regulation (MDR).
 
Certification and inspection officer Tom Patten said at the time that “Under the IVDR, you’re more than likely to need a notified body than to not need a notified body,” adding that almost all IVDs will require certification from a notified body. (RELATED: Euro Convergence: Experts share advice, concerns and expectations for IVDR, Regulatory Focus 03 November 2020)
 
Currently 22 MDR notified bodies are listed in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database
 
GMED, NANDO