2018 was another productive year for the European Pharmacopoeia (Ph. Eur.) Commission, a testament to its commitment to keeping abreast of new scientific developments and anticipate the need to create standards in some highly complex fields. Of the 41 new monographs adopted, eight covered active pharmaceutical ingredients (APIs) which are still under patent and are intended for use in medically important indications.
Momentum was gained in the development of finished product monographs and a regulatory gap was closed with the adoption of a new general chapter and two specific monographs on live biotherapeutic products. Finally, the reinstatement of the Gene Therapy Products (GTP) Working Party paves the way for future developments of the Ph. Eur. in this field.
The interest that the work of the Ph. Eur. Commission generates outside its current 39 signatory parties was demonstrated again with a request for observer status to the Commission received from the Republic of Uzbekistan, which was granted during the March 2018 session. International cooperation remained a priority throughout the year.
Much progress was made across the EDQM’s different healthcare activities: the 7th edition of the Organ Guide with updated information was issued last year to provide professionals with information on the most recent advances in the field, together with technical guidance to ensure the safety and quality of human organs for transplantation. In pharmaceutical care, a new set of Guidelines on Automated Dose Dispensing (ADD) services was finalised, which will guide regulators, suppliers and patients on how to supply ADD services and medicines while ensuring maximal safety for patients.
As part of the fight against falsified medicines and medical devices, our Know-X database was revised to facilitate smooth interaction between OMCLs and enforcement authorities involved in the fight against falsified medicines.
The first stone of the EDQM’s secondary site was laid in Metz, north-eastern France, in June. This new site is intended to store contingency stocks of the EDQM’s portfolio of over 3 000 pharmaceutical reference standards and will be key to ensuring the sustainability and continuity of the EDQM’s public health protection mission in the event of any emergency affecting the main EDQM building in Strasbourg.