Quality & use of medicines

Certification of suitability to the Ph. Eur. monographs

The Certification of suitability procedure was set up to evaluate and validate the conformity of substances used in the manufacture of medicinal products with the quality standards of the Ph. Eur. It includes a programme for the inspection of manufacturing sites of active substances, and Certificates of suitability (CEPs) granted to manufacturers provide assurance to both industry and national authorities that their products are adequately controlled by the Ph. Eur. quality standards. All EU states recognise CEPs, as do many global partners, including Australia, Brazil, Canada, Morocco, New Zealand, Singapore, South Africa and WHO.

Certification activities

New applications

0

(+23%)

Requests for revision of CEPs

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(-2%)

Requests for revision of Ph. Eur. monographs

0

(+2%)

New and revised CEPs granted

In 2024, the EDQM significantly expanded its activities with regard to the CEP procedure. A total of 469 new CEP applications were submitted, reflecting a 23% increase over 2023, while requests for revision saw a slight decrease of 2%, with approximately 2 360 received. Throughout the year, 581 new certificates were issued, marking a 31% rise compared to the previous year, alongside 1 732 revised certificates, an 18% increase. Processing times for both new dossiers and revisions improved throughout the year. There were over 6 800 valid CEPs covering chemical purity, transmissible spongiform encephalopathy (TSE) and herbal drug preparations as of 31 December 2024.

CEPs suspended and/or withdrawn

In 2024, 10 CEPs were suspended and/or withdrawn, mainly due to good manufacturing practice (GMP) non-compliance, highlighting the importance of EDQM inspections. An additional 15 CEPs were suspended at the request of the holders. On the other hand, 17 CEPs were restored after the companies concerned took appropriate action in response to the suspension of their CEP.

Communication with Ph. Eur. groups of experts: requests for revision of monographs

In 2024, 43 requests for revision of Ph. Eur. monographs were submitted to the relevant Ph. Eur. groups of experts for consideration, mainly proposing the addition of specified impurities to the monograph’s transparency list, together with a suitable test method. This aspect of the CEP procedure contributes to ensuring that the Ph. Eur. monographs continue to meet the evolving needs of its users.

The EDQM inspection programme

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on-site inspections

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RTEMIS inspection

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desktop assessments

The EDQM continued its GMP inspection programme for active substance manufacturers, conducting on-site and RTEMIS (Real-Time Remote Inspection System) inspections and using reliance principles (“desktop assessments”). A total of 31 inspections were carried out in 2024 (30 on-site and 1 RTEMIS), mainly in Asian countries. In addition, the EDQM enhanced its reliance programme for GMP inspections by doubling the number of desktop assessments for manufacturing sites, performing 79 such assessments through data exchanges with inspectorates from international partners.

CEP procedure: 30 years of scientific excellence

The year 2024 marked the 30th anniversary of the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure. Initially set up in 1994 with the ambition of centralising and harmonising the assessment of quality data for active substances covered by a Ph. Eur. monograph, this procedure was a response to a global challenge. The production of active pharmaceutical ingredients (APIs) had shifted to countries outside Europe, and to avoid duplication of effort and ensure that reliable standards were being consistently applied, regardless of the country of production, the CEP procedure enabled centralisation and harmonisation, a practical and scientific necessity. The CEP procedure has delivered on its promise for three decades now. It benefits manufacturers, regulatory authorities and public health systems alike by providing a single certificate – backed up by rigorous evaluations and GMP inspections ensuring the safety and quality of pharmaceutical substances – that is recognised by multiple regulatory authorities around the world.

Watch the CEP 30th anniversary session of the EDQM 60th anniversary conference below, for a lively and informative discussion of how the CEP procedure exemplifies the EDQM’s dedication to quality, collaboration and public health protection.

International co-operation

Throughout 2024, the Certification Department continued to work closely with national competent authorities (NCAs) in Europe and beyond. This continued co-operation is crucial to ensuring consistency in the approaches applied for the assessment of quality information on active substances, as well as for GMP implementation.

In October 2024, the EDQM welcomed the decision from the Brazilian Authority (Anvisa) to rely on the CEP evaluation procedure in their decision-making process for the quality of active substances.

As part of its strategic objectives, the EDQM strives to respond to current and emerging public health challenges and priorities for the benefit of patients and consumers. In terms of the Certification procedure, this implies exploring the possibility of increasing the recognition of its inspection results.

In 2024, the Certification Department continued to host the International API Inspection programme secretariat. This programme is an initiative of various authorities and organisations around the world with the goal of increasing the efficiency of their individual GMP inspection activities by increasing reliance and reducing unnecessary redundancies.

Communication with applicants, partners and stakeholders

Facilitating the understanding and use of the Certification procedure

In April and November 2024, the Certification Department held webinars for stakeholders to share information and gather feedback on the use of the CEP 2.0, the challenges users may encounter in the preparation of CEP applications, the use of CEPs, as well as finding and making best use of EDQM guidance (see the list of webinars under Achievements). The EDQM communicated regularly via its website throughout the year.

Update of CEP guidelines

The EDQM Certification Department published a number of new or updated guidelines in 2024. Among these, key documents for the preparation of CEP applications were revised to help applicants submit their dossiers and to align with the most recent regulatory requirements. As part of the procedure, CEP stakeholders were invited, via the public consultation process, to comment on draft documents and guidelines issued by the EDQM. Find out more on the dedicated Certification web page.

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