Euro Roundup: MHRA updates guidance on submitting safety reports for UK products
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new advice about periodic safety update reports (PSURs).
MHRA’s update centers on the European Union Reference Date (EURD) list. The EURD list is the European Medicines Agency’s comprehensive repository of individual and combined active substances contained in authorized medicinal products. First published in 2012, the list’s information includes the frequencies for submission of PSURs.
Despite Brexit, MHRA continues to require PSURs for UK products to be submitted according to the EURD list. The updated guidance addresses how marketing authorization holders (MAHs) can comply with that demand in a specific circumstance.
“If your active is removed from the EURD list you should continue with the PSUR frequency last presented in the EURD list unless you are informed otherwise,” MHRA said. “In order to support this, it is recommended that you retain a copy of the EURD list that last contained the entry for your active.”
EMA updates the EURD list each month based on new safety information, authorizations, and requests from MAHs. MHRA’s revised guidance clarifies that UK requirements for submitting PSURs are unaffected by the cessation of EMA requirements. A similar situation is already present within the EU, where some products assessed at a national level are excluded from the list but still subject to PSUR requirements.
EDQM revises advice on electronic Certificate of Suitability applications
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has revised its guidance on applying for a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).
EDQM updated its advice on applying electronically for a CEP to reflect current requirements, specifically regarding the need to provide an electronic common technical document (eCTD) validation report. The directorate began requiring applicants to provide an eCTD validation report as part of eCTD submissions in November. EDQM introduced the requirement as part of a push to automate processes.
To help applicants comply with the requirement, EDQM updated its guidance on electronic submissions of CEP applications. The update, which EDQM made last week, describes how the eCTD validation report should be named. Other new information covers the right place to put the report in the CEP application and EDQM’s preferred format.
EDQM also clarified that changes to the content of module 3 of a CEP application should be described in module 1. Applicants should not highlight the content changes in module 3 itself. EDQM is encouraging applicants to consult the updated guidance to ensure they comply with the revised requirements when preparing CEP submissions.
Swissmedic enhances portal to eliminate need for temporary workaround
The Swiss Agency for Therapeutic Products (Swissmedic) has changed the software architecture for its portal to better support its evolving business requirements.
Through the changes, Swissmedic has created a new dedicated overview page that provides access to all currently valid establishment licenses. Users can select entries in the table to view the corresponding license details. Making the details available directly within the portal marks the end of the use of a temporary workaround, which required users to view the information through the partner overview.
Swissmedic is planning further improvements to the establishment license overview page. The next step is to provide historical establishment license data within the same overview and allow users to filter and select license records by status. The feature will be available in “the near future,” Swissmedic said.
The agency disclosed the changes alongside other updates to the portal. Swissmedic has changed the navigation structure to “improve future scaled usability needs” and added the option to temporarily change the display language of the portal.
Other changes lay the foundations for further updates. By moving to a new URL structure, Swissmedic has provided the basis for the addition of business domains, such as medicinal products, in the future.
NICE backs Lilly’s weekly insulin for UK use ahead of MHRA approval decision
The UK National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Eli Lilly’s weekly insulin for the treatment of type 2 diabetes.
NICE’s decision, which arrived before MHRA approval, requires the English health service to fund Lilly’s insulin efsitora alfa for type 2 diabetes. Healthcare professionals should use the least expensive of the suitable treatments, including insulin efsitora alfa and once- or twice-daily basal insulin. Assessments of expense should consider administration costs, dosages, price per dose, and commercial arrangements.
“The biggest cost saving from using insulin efsitora alfa comes from people needing less support to take their insulin. This is because insulin efsitora alfa is taken once a week rather than every day,” NICE said. “An average of one hour with a specialist district nurse for diabetes is assumed each time a person needs help taking insulin.”
NICE’s comparison suggests the overall cost of insulin efsitora alfa, which Lilly will sell as Onswik, may be the same or cheaper than once- or twice-daily basal insulin. While NICE has backed Onswik, MHRA has yet to approve the product for use in the UK.
Turkish board probes impact of Teva’s patent practices on pharma competition
The Turkish Competition Board is investigating whether Teva Pharmaceutical tried to make it harder for competitors to enter a market.
In a preliminary inquiry, the board looked at whether Teva engaged in conduct intended to restrict competition from generic medicines. Potentially anticompetitive practices assessed by the board include “the strategic use of divisional patent procedures” and the creation of “a misleading impression before healthcare authorities regarding the efficacy and safety of competing products.”
The term “divisional patent procedures” describes splitting an initial application into multiple filings, for example to tackle concerns about single submissions claiming multiple inventions. Medicines for Europe, a trade group representing generic drugmakers, has warned that allowing unlimited filing of divisional patents opens the door to a widespread misuse of the system to artificially delay competition.
Going forward, the Turkish board will investigate Teva patent applications relating to a manufacturing process and dosage regimen. The board wants to know whether the patents, together with associated withdrawal practices, could restrict competition from generic medicines. Last year, Teva appealed an EU fine of €462.6 million ($539.1 million) related to claims it tried to delay competition to Copaxone.
France’s ANSM enlists 14 drugmakers for pilot push to increase drug shelf lives
The French National Agency for Medicines and Health Products Safety (ANSM) has started a pilot project to extend the shelf life of 73 medicines.
Last year, ANSM called for applications from drugmakers that intended to file to increase the shelf life of a product in the next five years. The agency received responses from 14 drugmakers, including AstraZeneca, that will participate in the pilot project to increase the shelf lives of widely used medicines such as paracetamol.
Currently, the products have shelf lives of 12 to 48 months. The targeted shelf lives range from 24 to 60 months. Boiron aims to extend the shelf life of one product from 12 to 60 months. Almost two-thirds of the products will have shelf lives of 48 months or longer if the pilot achieves its targets. ANSM framed the project to reduce waste and the environmental impact of drug production and disposal.
ANSM Notice (French)
