The year 2019 saw important progress in all EDQM activities. The European Pharmacopoeia Commission appointed more than 850 members to its groups of experts and working parties for a new term of office of three years.
Altogether, the Ph. Eur. was complemented with 19 new monographs, 5 new chapters and 233 revised texts in 2019, ensuring constant alignment with state-of-the-art technologies and regulatory developments. The European Pharmacopoeia also welcomed a new member state, Albania.
A secondary site was inaugurated as part of the EDQM business continuity plan, which includes the creation of a full backup stock of reference standards in order to mitigate risks of disruptions to supplies.
The Ph. Eur. Commission, the OMCL Network and the Certification Department played a crucial role in further measures taken to investigate and prevent the contamination of active pharmaceutical ingredients and medicinal products with nitrosamines.
European and national authorities worldwide were supported through the revision of monographs, the development of analytical testing methods, the evaluation of data requested from CEP holders and the inspections of impacted manufacturing sites.