The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its annual report, summarising the organisations 2022 highlights.
Petra Doerr, Director of EDQM, Council of Europe, commented in the report on the current challenges of drug shortages in the pharmaceutical supply chain and its impact on the industry’s resilience and goals towards sustainability.
Key activities and achievements shared in the EDQM annual report
In terms of activities regarding the quality and use of medicines, in 2022, the EDQM adopted 23 new monographs, two new general chapters and 186 revised texts.
Selected European Pharmacopoeia texts adopted in 2022 were:
- Two general monographs: Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) were revised to include a paragraph explaining the Ph. Eur. approach to N-nitrosamine impurities
- One new general chapter: 5.26. Implementation of pharmacopoeial procedures
- One harmonised general chapter: 2.2.46. Chromatographic separation techniques
- Two revised harmonised monographs: Paraffin, white soft (1799) and Paraffin, yellow soft (1554).
11th Edition of the European Pharmacopoeia conference
The EDQM annual report mentioned the transition to the 11th Edition of the European Pharmacopoeia. An international conference marked this move and aided in generating feedback that will help shape the 12th Edition over the next three years.
Several of the key areas deliberated on during the conference were the importance of pursuing harmonisation of pharmacopoeial quality standards globally and the potential of nanomedicines, including mRNA vaccines against COVID-19. Another theme discussed was the place of Big Data in the pharmaceutical industry.
In March 2022, the first ‘horizontal’ standard for monoclonal antibodies was adopted by the European Pharmacopoeia Commission (EPC). The new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), is the first of three planned new horizontal standards for monoclonal antibodies (mAbs).
In 2022, one of the priorities for the EDQM was quality management systems (QMS). As a result, the EDQM annual report illustrated that 780,000 European Pharmacopoeia reference standards vials were produced that year.
Because it is important to predict future needs regarding the application of new analytical technologies, five new working parties were created in 2022:
- mRNA vaccines (mRNAVAC) working party
- High Throughput Sequencing (HTS) working party
- Excipients Strategy (EXS) working party
- Analytical Quality by Design (aQbD) working party
- Aluminium (ALU) working party.
Furthermore, the EDQM continued to participate in the Innovative Medicines Initiative’s (IMI) vaccine batch to vaccine batch comparison by consistency testing (VAC2VAC) project.
Finally, to secure the future success of the EDQM, Doerr emphasised that a key factor is collaboration.