Euro Roundup: MHRA considers new regulatory framework for personalized medicines

MHRA seeks comment on making personalized point-of-care drugs

The UK Medicines and Health Products Regulatory Agency (MHRA) is investigating whether the production of personalized point-of-service (POC) medicines is different enough from standard manufacturing to require the creation of a new framework.

Unlike traditional drug manufacturing, where fewer facilities, working on a large scale, manufacture products for global distribution, POC shifts production in or very close to the healthcare site that administers the drug. Some cell therapies are high-profile examples of POC production, but MHRA has also seen blood products, medical gases, and small molecules made near the site of administration. The MHRA is considering a new regulatory framework for POC products.

The proposed regulatory framework is designed to support “the growth of an emerging pharmaceutical manufacturing and supply sector” that will complement the existing supply chain. The MHRA aims to guarantee equivalent levels of safety without imposing unnecessary regulatory barriers on POC products.

In discussing with stakeholders to develop the framework, the MHRA identified challenges with the short shelf life of many POC products, which requires local production and makes current methods of quality control testing and testing impossible. certification of qualified persons. Additionally, while a traditional drug is typically manufactured at three to five sites, the production of POC drugs can involve hundreds of sites, which presents additional challenges for conducting inspections and naming individual sites on marketing authorizations. on the market.

The MHRA offers the concept of “control site” 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’s production activities, including the addition of new manufacturing sites.

The monitoring site would maintain a master file of POCs that the MHRA would review to assess compliance with good manufacturing, clinical and pharmacovigilance practices. The MHRA provides an annual report related to the routine re-inspection of the POC manufacturing system. The agency provides for regular and risk-based inspections of control sites and selected manufacturing sites.

Before moving forward with the changes, the MHRA wants to know if stakeholders agree with the need for a specific POC framework and, if so, if they agree with the regulatory framework. offers. The agency is also seeking feedback on whether to adapt or expand the proposed framework to cover home and modular manufacturing.

The MHRA is accepting comments until September 23. If, as expected, the regulatory framework for the POC is incorporated into UK law, the MHRA will develop additional guidance covering the application process and other operational activities.

MHRA Notice, Plus

UK competition watchdog begins investigating quality of COVID-19 PCR tests

The UK Competition and Markets Authority (CMA) has started 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 issues suggesting COVID-19 tests for travel are ‘on the verge of collapsing’, with photographs posted online showing swab drop boxes operated by Randox overflowing with unprocessed kits. Travelers from countries on the UK Green and Orange List must undergo a PCR test on the second day after returning home.

Sajid Javid, Britain’s Health Secretary, responded to concerns by asking the CMA to consider looking into the matter. The CMA is currently examining whether providers of COVID-19 PCR tests are in breach of their obligations under consumer law, whether structural issues in the PCR market are affecting price or reliability, and whether the government could take action. to improve the situation.

“We also work closely with [the Department of Health and Social Care] to get the data we need to identify the root cause of any broader problem in the PCR testing market and to base our advice on what action might be needed, ”said George Lusty, CMA Senior Director for Protection of consumers.

CMA Notice

Finland shares advice on substitutes and price notifications

The Finnish Medicines Agency (Fimea) shared information on substitutable medicines and the price notification procedure in collaboration with counterparts from the Social Insurance Institution and the Pharmaceutical Pricing Board.

Before each quarter, Fimea publishes a list of substitutable drugs. Fimea asks 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 guidelines also state that price notifications should be sent to the Social Insurance Institution, also known as Kela, “for any drug for which notification is required under reference price systems. and generic substitution “. Notifications must be submitted at least 21 days before the first day of each quarter. The notifications inform the price brackets and the benchmark prices.

Fimea said notifications must be submitted even if the price of a drug product is unchanged, and are also needed for non-refundable products. “This ensures that drugstore price lists are accurate and up to date for all products included in the generic substitution and reference price systems,” Fimea wrote in its guidelines.

Fimea review

Moderna obtains UK conditional approval for COVID-19 vaccine in adolescents

Moderna has received conditional marketing authorization in the UK for its COVID-19 vaccine in people aged 12 to 17. The approval means two vaccines are now approved for use in children in the UK, although none are used routinely in people under 16.

The MHRA based its conditional authorization on the same Phase 2/3 clinical trial data in the United States that Moderna used to gain approval in other markets, including Switzerland. The study found that the tolerability of the vaccine is similar in adults and adolescents, with pain at the injection site, headache and fatigue being the most common side effects.

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 vaccinate children as young as 12, the UK has only recently lowered the minimum age to 16. Young children can only be vaccinated if they are at increased risk of getting severe COVID-19 disease or if they live with someone who is immunocompromised.

MHRA Notice, Plus

EMA begins evaluating use of Roche’s arthritis drug in severe COVID-19 patients

The European Medicines Agency (EMA) has started evaluating the use of Roche’s arthritis medicine RoActemra in hospitalized adults with severe COVID-19. Roche received emergency use authorization in the United States for the indication in June and a strong recommendation from the World Health Organization in July.

The EMA Committee for Medicinal Products for Human Use will conduct a fast-track assessment of data from four large randomized studies before deciding whether to expand the RoActemra label in the EU. A decision is expected by mid-October, unless the EMA needs additional information to complete its review.

The authorization in Europe could put more pressure on supplies to RoActemra, which is sold under the name Actemra in certain markets. Australian authorities acted earlier this month to ensure that people with rheumatoid arthritis and other non-COVID-19 indications treated with the drug can access the IL-6 inhibitor. Roche later said that Actemra’s demand is “well above 400% of pre-COVID levels.”

EMA opinion

GMED receives notified body designation for IVDR

The French company GMED has announced that it has received the designation of notified body under the EU In vitro Diagnostic Regulation (IVDR) entered into force on August 20, making it the sixth IVDR notified body.

The deadline for the entry into force of the IVDR regulation is May 26, 2022; regulators and industry have long been concerned about the lack of notified bodies to complete conformity assessments in anticipation of this deadline.

Speaking at RAPS Euro Convergence 2020, an official from the National Standards Authority of Ireland stressed that the role of the notified body is even more central to the implementation of IVDR than it is. was for the entry into force of the Medical Device Regulation (MDR).

Certification and Inspection Officer Tom Patten said at the time that “Under IVDR you more than likely need a Notified Body than you don’t need a Notified Body” , adding that almost all IVDs will require certification from a Notified Body. (RELATED: Euro Convergence: experts share their advice, concerns and expectations in RDIV, Regulatory focus 03 November 2020)

Currently, 22 MDR Notified Bodies are listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database.


© 2021 Society of Regulatory Affairs Professionals.

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