Euro Roundup: MHRA targets 150-day turn for priority, good quality drug dossiers
The UK Medicines and Healthcare products Regulatory Agency (MHRA) expects to process all “priority and good quality dossiers that are compliant with legislative data requirements” within 150 days starting in 2024.UK statutory timelines give MHRA up to 210 days to process national applications for medicine approvals, but the agency has targeted a 150-day turnaround for some applications in recent years. At the end of 2020, MHRA published guidance on its offer of a 150-day assessment timeline for high-quality marketing authorization applications covering new and existing active substances and biosimilar products.
While the guidance outlined how to apply for a 150-day review, the median number of elapsed days for national applications over the 12 months up to May 2023 was over 200.
This week, Will Quince, a minister of state in the ruling Conservative Party, outlined the steps MHRA is taking to reduce turnaround time and set a target for how long it will take the agency to consistently meet the truncated timeline.
“MHRA is proactively engaging with the relevant Trade Associations on how best to improve the quality of marketing authorization applications, including workshops to support companies. With the measures put in place, the MHRA anticipates that all priority and good quality dossiers that are compliant with legislative data requirements received from 1 January 2024 will be progressed within 150 days,” he said.
The current 210-day turnaround is the same as the standard review time in the EU and shorter than the 10-month target in the US. EU and US agencies both offer accelerated reviews, which shorten the process to 150 days and 6 months, respectively, but that option is limited to medicines considered of major interest for public health, for example, because they significantly improve on existing options.
MHRA’s guidance on 150-day reviews applies to all high-quality applications. As such, the guidance and Quince’s comment suggest that applications that cover all the required common technical modules and other information requested by MHRA will benefit from an accelerated review.
Quince published his statement days after MHRA updated its guidance. The latest version of the document also features a new section on Access Consortium work-sharing procedures, asking organizations that are planning to submit national applications for new active substances, biosimilars or new indications to consider filing via the work-sharing procedure.
Written Response, MHRA Guidance
EFPIA raises concerns about effectiveness, feasibility of EU antimicrobial resistance plan
EFPIA has raised concerns with aspects of the recently adopted European Council recommendation on how to combat antimicrobial resistance.
In a statement, the big pharma trade group identified the “Union multi-country pull incentive” as an area of concern. The Council recommendation says the scheme could “take the form of revenue guarantee, market entry rewards combined with revenue guarantee, lump-sum market entry rewards or milestone payments and may be financed at EU level, national level or co-financed.”
EFPIA has concerns with “the effectiveness and feasibility” of an incentive “with voluntary participation and an unclear financing mechanism.” The trade group said it “is essential to uphold and reinforce the pull incentive proposed by the European Commission, namely the transferable exclusivity voucher” in the EU general pharmaceutical legislation.
“It is crucial that any policy measure designed to incentivise antimicrobial development and access provides sufficient predictability and, most importantly, the financial commitment at the scale required to make a meaningful impact on R&D decision,” EFPIA wrote.
MedTech Europe also posted a statement on the Council’s recommendation, calling for “measures that prevent, detect, and manage infections and resistance” and claiming that “medical technology tools and software that support such measures exist and, more importantly, are immediately available.”
EFPIA Statement
EDQM seeks feedback on updated policy on chemical purity and microbiological quality
The European Directorate for the Quality of Medicines and Healthcare (EDQM) is holding a consultation into a revised policy document on the content of certain Certificate of Suitability (CEP) applications.
The draft policy document will serve as a guide for companies that want to compile dossiers to obtain a CEP for chemical purity and microbiological quality. Like the current version of the document, the draft outlines the materials and information that applicants should include in modules one to three of the CEP application. Information about the third module dominates both the existing and draft policies.
EDQM’s draft policy on module three starts with a request to structure the information “according to CTD as defined by ICH M4” and features a reminder that “compliance should be demonstrated not only to the individual Ph. Eur. monograph the substance refers to, but to all applicable Ph. Eur. monographs.” The draft then provides a revised, expanded version of the information in the current document.
The draft document is open for comment until 15 September.
EDQM Notice
Swissmedic updates guidance on the authorization of complementary medicines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on complementary medicinal products, including revisions regarding the quality of active substances.
The guidance describes the documentation for the submission and simplified authorization of a range of complementary medicines, including homeopathic and anthroposophic medicinal products. Swissmedic has moved and changed a section on the quality of the active substance, which describes requirements for starting materials, primary containers, excipients and stability documents.
Other changes include the addition of a subsection titled “further requirements” in the section on the full declaration form. The subsection provides information on pharmaceutical forms that contain ethanol, liquid pharmaceutical forms, medicinal products that are dosed in drops and more.
Swissmedic also changed or clarified information about stating the drop equivalent for eye drops, the listing of sodium-containing excipients, packaging texts for medicinal products with indication for medicine cabinets and the listing of the standard text concerning the indication.
Swissmedic Notice
EU committee pushes Commission to ‘make full use’ of options if UK breaches new Brexit deal
An EU committee has called for the European Commission to “monitor the implementation and application of the safeguards” of the new Brexit agreement and “stand ready to make full use of the dispute resolution tools” if the UK breaks the rules.
Concerns over the impact of the original agreement on the availability of medicines in Northern Ireland and other factors led the EU and UK to re-negotiate terms earlier this year. The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) recently issued an opinion on the revised terms. ENVI welcomed the medicines proposal as a “permanent solution.”
However, ENVI also identified risks associated with the new model. Specifically, the committee asked the Commission to monitor “aspects related to anti-tampering device measures in the UK” and warned that the “flexibility provided by the medicines proposal will need to be properly monitored to prevent the unlawful distribution of UK medicines marketed for Northern Ireland into the internal market.”
ENVI Opinion
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