This year marks the 30th anniversary of the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) Procedure, established by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Since 1994, the CEP procedure has significantly contributed to the efficiency of the marketing authorisation process for medicines containing substances covered by a European Pharmacopoeia (Ph. Eur.) monograph and has become a key factor for ensuring public health protection, regulatory efficiency and global harmonisation. The procedure also actively contributes to the revision of Ph. Eur. monographs.
The evolution of the Certification procedure
The CEP procedure was created with the ambition of centralising and harmonising the assessment of quality data for substances covered by a Ph. Eur. monograph. It was a response to a global challenge, at a time when the production of active pharmaceutical ingredients (APIs) had shifted to countries outside Europe. To avoid reproduction of effort and ensure that reliable standards were being consistently applied, regardless of the country of production, this centralisation and harmonisation had become a practical and scientific necessity.
The CEP procedure initially focused solely on controlling the chemical purity of active substances. Its scope has since expanded in response to evolving scientific and regulatory needs.
- 1999 – Inclusion of products with a transmissible spongiform encephalopathy (TSE) risk.
- 2004 – Extension to herbal drugs and herbal drug preparations, aligning with the increasing use of natural products in medical practice. In the same year, the EU pharmaceutical legislation recognised the use of CEPs in marketing authorisation applications.
Eighteen new CEPs were granted in 1994; 442 were granted in 2023. The number of valid certificates has also grown steadily over the years to more than 6 700 today, and over 100 assessors from all over Europe now work with the EDQM. Today, CEPs are a widely accepted tool facilitating regulatory procedures.
The EDQM’s inspection programme, introduced in 1999, verifies Good Manufacturing Practice (GMP) compliance at manufacturing sites for APIs covered by a CEP. The number of inspections has increased from five in 1999 to 26 on-site and two Real-Time Remote Inspections (RTEMIS) in 2023, with a focus on Asian manufacturers, reflecting global production. Innovations like RTEMIS ensure ongoing efficiency and business continuity. In addition, the EDQM increasingly relies on inspections performed by other inspectorates, either by recognising their GMP certificates or considering their inspection reports during its paper-based inspections.
Benefits and global impact
The CEP procedure centralises the evaluation of pharmaceutical substance quality, offering a streamlined approach that benefits manufacturers, regulatory authorities and patients alike.
- For manufacturers – CEPs provide a single certificate that is recognised by multiple regulatory authorities, avoiding duplication of effort and enabling faster access to global markets.
- For regulatory authorities – By relying on the work done in the framework of the procedure, they save resources and facilitate alignment with the European Pharmacopoeia’s evolving standards.
- For public health – Rigorous evaluations and GMP inspections ensure the safety, and quality of pharmaceutical substances, thereby protecting patients worldwide.
Today, CEPs are recognised by regulatory agencies on every continent. The latest in date is ANVISA, the Brazilian national medicines authority. This benefits regulatory authorities and industry alike. All in the name of public health.
As the EDQM celebrates its 60th anniversary, the 30 years of the CEP procedure exemplify its dedication to quality, collaboration and public health protection.
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