Regulatory Focus™ > News Articles > 2022 > 1 > Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

Posted 13 January 2022 | By Nick Paul Taylor 

Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

2823 The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.
Companies working with active substances, raw materials, starting materials or excipients that are the subject of a European Pharmacopoeia monograph can request a CEP from EDQM and include the text in their applications instead of certain data that is typically needed. The current CEP is very similar to the original version created in 1992. With globalization, digital technologies and regulatory developments reshaping the pharma industry since then, EDQM identified a need to create a modern CEP.
EDQM set out its plans to improve transparency, user-friendliness, acceptance of CEPs and the simplicity of registration activities using the certificates in a consultation in 2020. The consultation attracted 150 responses from industry and authorities and, according to EDQM, received “no major divergent views ... with respect to the topics covered in the survey.” EDQM has revealed the highlights of the responses.
“There was a strong demand to include more information in CEPs, including statements on what is approved and what is not approved, to increase transparency and clarity for users, but also to avoid questions from both authorities and marketing authorisation holders,” EDQM wrote in its summary.
EDQM said most respondents want “more of the information included in CEP files to be approved by the EDQM and covered within the CEP document in order to avoid questions or assessment of marketing authorization applications.” The directorate also reported “strong calls to find ways to reduce revisions of CEPs.”
Specific content suggestions included the addition of more details on all sites involved in manufacturing in order to understand the supply chain and roles of each site, and greater transparency regarding the specifications of the substance covered by the CEP. Respondents also expressed a “clear preference” for an electronic CEP and for the certificate to have a tabular form for easy consultation.
EDQM identified five areas of work based on the feedback. The directorate is now working to reduce CEP revisions, enhance digital tools, foster information sharing, train users and review information reported in the certificates. EDQM will work on the changes over the first half of the year and discuss proposals with relevant stakeholders in the second half of the year. The goal is to have the CEP of the future ready for deployment at the beginning of next year.
EDQM Notice, Consultation Outcome
EFPIA calls for enhanced expedited pathways in recommendations for legal changes
EFPIA has identified four priority areas for legislative change to help re-establish Europe as a world hub for medical innovation. The European trade group is calling for changes including the enhancement of the expedited pathways framework and the expansion of EMA’s role in drug-device combinations.
After consulting with its members, EFPIA wants the EU to address “longstanding pathway issues” such as the clarity and predictability of criteria for expedited timelines and the expansion of the PRIME eligibility criteria. On the drug-device front, EFPIA is calling for the creation of a new legal category for combination products and EMA accountability in assessing the products and coordinating companion diagnostic work.
The other two recommendations cover the removal of “unnecessary interfaces” between EMA, working parties, the Commission and committees and the replacement of paper patient information leaflets with electronic versions. EFPIA thinks the removal of interfaces can “ensure global competitiveness through enhanced expertise-based assessment and an efficient and swift process for the legally binding decisions.”
EFPIA Notice
EMA: Preliminary data suggest COVID-19 vaccines protect against severe omicron infection
Vaccination against COVID-19 continues to provide a high level of protection against severe disease and hospitalization linked to the omicron variant, according to the European Medicines Agency (EMA). The agency based its conclusion on studies from South Africa, the United Kingdom and European Union.
Multiple studies have now shown a steep drop off in protection against symptomatic COVID-19 infection with omicron compared to delta, especially in the absence of a booster dose. However, protection from severe COVID-19 appears to hold up better. EMA quoted a South African study that found two doses give up to 70% protection from hospitalization, and UK work that shows boosters bring the figure up to 90%.
“EMA will continue to review data on vaccine effectiveness and severity of the disease, as well as the evolving landscape in terms of circulating variants and natural exposure to omicron, as they become available. The outcome of these assessments may impact future vaccination strategies recommended by experts in EU/EEA Member States,” the agency wrote.
While omicron has reduced protection against symptomatic disease, EMA emphasized that “vaccination remains an essential part of the approach to fighting the ongoing pandemic” and called for continued effort to increase full vaccination uptake and accelerate the roll-out of booster doses.
EMA Notice
Pfizer files for conditional EMA approval of oral COVID-19 antiviral Paxlovid
Pfizer has filed for conditional EMA approval of its oral COVID-19 antiviral Paxlovid. The filing covers the use of Paxlovid in the treatment of mild-to-moderate COVID-19 in adults and adolescents who are at high risk of progression to severe disease.
EMA plans to assess the submission “under a reduced timeline and could issue an opinion within weeks.” That target is predicated on the data submitted by Pfizer being “sufficiently robust” and it being possible to reach an opinion without requesting further information. Pfizer’s successful applications for approval in other markets suggest it should have the data to satisfy EMA at the first time of asking.
The EMA review is happening in parallel to the Pharmacovigilance Risk Assessment Committee’s (PRAC) assessment of the risk management plan. PRAC is assessing Pfizer’s measures to identify, characterize and minimize the medicine’s risks.
EMA Notice
Ireland’s HPRA recommends removal of rapid COVID-19 test over false positives
Ireland’s Health Products Regulatory Authority (HPRA) is recommending the Genrui SARS-CoV-2 Rapid Antigen Self-Test be removed from sale. HPRA made the recommendation after receiving 550 reports of false positives “in recent days.”
While all rapid antigen tests can deliver false positives, HPRA said the “rapid rise” in reports related to the Genrui kit is “significant.” The rise prompted HPRA to recommend the precautionary removal of the test from sale while the China-based manufacturer and its European representative investigate the issue. Retailers are removing the test and HPRA is recommending against online purchases.
HPRA is in contact with other European authorities about the false positives. The Spanish regulator has also issued a notice about the test, and the German city of Hamburg is sourcing other tests for its schools in response to a high number of false positives.
HPRA Notice
Other News:
EMA has posted a guide to registering on its database for veterinary medicinal products. The guide walks through the process for registering on the Union Product Database, which EMA has created to meet the requirements of the new regulations on veterinary medicines. EMA said the registration steps are similar to those for its other systems such as EudraVigilance Veterinary. EMA Guide
EDQM has published a document to help stakeholders understand the advantages of applying for a monograph elaboration via European Pharmacopoeia procedure 4. EDQM Notice


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