Euro Roundup: EDQM shares top 10 deficiencies Certificate of Suitability applications
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the top 10 deficiencies found in applications for Certificates of Suitability (CEP) for chemical purity last year.EDQM analyzed a random sample of 30 deficiency letters sent after carrying out initial evaluations of new CEP applications. The top deficiency was a lack of details or poor description of the manufacturing process of the substance from the introduction of starting materials, accounting for 12% of all the questions raised by EDQM.
The directorate shared details of the deficiencies identified, explaining that applicants should provide a flow diagram for synthetic and semi-synthetic substances and list the quantities of all raw materials used at each step in the manufacturing process. Last year, the lack of such information caused delays.
“The failure of applicants to satisfactorily address some of the deficiencies…in their application resulted in an increase in the number of questions raised during requests for additional information by EDQM along with their complexity,” EDQM wrote. “Consequently, the timeline for granting of the certificate of suitability was increased.”
The new document “is intended to help applicants avoid such issues,” the directorate said. Applicants should consider the points raised in the document in conjunction with the EDQM guideline Content of the Dossier for Chemical Purity and Microbiological Quality of Substances for Pharmaceutical Use, which outlines the specific requirements for submitting CEP applications.
Non-adequate or poorly justified specifications proposed to control the quality of isolated intermediates were the second most common deficiency (11%). Problems with specifications for starting materials were also common (7%), as were the absence or deficient discussion on the risk of mutagenic impurities in the final substance (7%) and the absence or inadequate acceptance criteria for raw materials (7%).
EDQM Notice
EMA seeks more academic and non-profit applicants for cell and gene therapy pilot scheme
The European Medicines Agency (EMA) has made a fresh call for academic and non-profit developers of cell and gene therapies who might want to participate in a pilot scheme.
EMA unveiled the pilot in September 2022, when it enrolled the first participant and then set a goal of selecting up to five candidates by 2024 (RELATED: EMA project supports non-commercial ATMP developers, Regulatory Focus, 06 October 2022). The agency enrolled an additional three organizations by the end of 2023.
To be considered, applicants should apply by the end of April. EMA plans to pre-select candidates in June and reach a final decision in November. The agency expects to have the initial results of the pilot program next year.
EMA has updated its question-and-answer document for new applicants, clarifying that it is interested in candidates with patient response and safety data in the targeted indication generated in exploratory clinical studies. EMA added that it will prioritize projects where its support “could be more impactful” because of the “limited number of products and the timeframe associated with the pilot.”
When applicants are already part of EMA’s priority medicine program, the agency will “consider the need for the additional support and benefits of the pilot as an add-on to the developmental support already offered via the PRIME scheme.” EMA also published details of fee reductions and waivers that match the discounts it already offers to small organizations.
EMA Notice
Swissmedic delays go-live date for swissdamed medical device database
The Swiss Agency for Therapeutic Products (Swissmedic) has delayed the go-live date for its swissdamed medical device database until the second half of this year.
Because the agreement on mutual recognition of conformity assessments between Switzerland and the EU has lapsed, Swissmedic directly registers economic operators, medical devices, and in vitro diagnostics. Swissdamed is intended to facilitate the work and enable the application of Swiss regulations on medical devices and in vitro diagnostics.
Swissmedic began work on the database in April 2022. Later that year, the regulator began targeting a go-live date in 2023. The agency dropped that target last year as part of an update that set new goals for the availability of modules on registering economic operators and devices, as well as the freely accessible search function.
Now, Swissmedic has delayed the registration of the economic operators module and search function until the second half of 2024, compared to early in the year under the old plan. The device module, due in the summer of 2024, will now arrive as a minimal viable product four months after the economic operator module goes live. The delays echo setbacks to the release of the EU medical device database.
Swissmedic Notice
EMA’s safety committee warns about potentially fatal reaction to Pfizer’s COVID-19 antiviral
EMA’s safety committee has reminded healthcare professionals of the risk of potentially fatal reactions when Pfizer’s COVID-19 antiviral Paxlovid is used in combination with certain immunosuppressants.
The Pharmacovigilance Risk Assessment Committee (PRAC) issued the reminder after reviewing reports of serious adverse reactions resulting from drug-drug interactions between Paxlovid and two classes of immunosuppressants. Blood levels of the immunosuppressants can increase rapidly to toxic levels when given with Paxlovid, resulting in life-threatening conditions. Some patients have died.
PRAC’s advice applies to calcineurin inhibitors such as tacrolimus and mTOR inhibitors, including everolimus. The safety committee is recommending that Paxlovid is only given to patients who are taking the immunosuppressants if “close and regular monitoring of their blood levels is possible, to reduce the risk of drug-drug interactions causing serious reactions.”
Officials are preparing a direct communication with healthcare professionals to share the advice.
EMA Notice
MHRA increases the fee for registering medical devices by 140%
The Medicines and Healthcare products Regulatory Agency (MHRA) has increased its fee for submitting new medical device registrations or applying to make changes to existing registrations.
MHRA set the fee at £100 ($125) when it published guidance on regulating medical devices at the end of 2020 as part of the changes triggered by Brexit. Last week, the agency raised the fee to £240, an increase of 140% over the previous rate.
Officials proposed the increase in 2022 after identifying medical device registration as one of 61 areas where MHRA was significantly under recovering fees. The industry pushed back against plans to increase the 61 fees, with 56% of respondents to a consultation opposing the changes. Still, the agency forged ahead because “it is essential that the MHRA cost-recovers across all services.”
MHRA Guidance
Other news:
MHRA has begun using a genetic biobank to investigate direct oral anticoagulants prescribed to prevent strokes. The agency is contacting people who report excessive bleeding after taking the medicines to ask for a blood sample for analysis. MHRA Notice
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