The COVID-19 pandemic marked the year 2020, but the EDQM, operating on the front lines of public health protection, immediately drew up contingency plans for all its branches of activity and continued to fulfil its mission despite the necessary restrictions on travel, shipping and contact between individuals. Even in such a difficult context the European Pharmacopoeia (Ph. Eur.) continued to grow, not only in terms of its scope (29 new monographs, six new chapters and 250 revised texts were added to the compendium) but also in terms of its membership and outreach: Albania became a member state in February and Mexico an observer in May.
With a vital role to play, the EDQM once again proved its relevance for health systems worldwide.Read more With “business as usual” both impossible and more necessary than ever, the EDQM quickly transitioned to ensuring the continuity of its core activities through a series of measures enabling the Ph. Eur. Commission to respect its work programme; safeguarding the supply of reference standards; ensuring the processing of applications for new, revised or renewed certificates of suitability (CEPs); and guaranteeing the quality control of medicines, including the Official Control Authority Batch Release (OCABR) procedure, through the Official Medicines Control Laboratories (OMCL) Network.
The EDQM also maintained its guidance and standard-setting activities in the areas of blood transfusion, organ, cell and tissue transplantation and consumer health. Communication structures were set up, indispensable procedures and processes were adapted and work organisation as a whole was reformed to weather what was to become a prolonged ordeal.
Moreover, the EDQM actively supported competent authorities, manufacturers and developers of medicines (including vaccines) and health professionals, and contributed to the wider global effort to combat the coronavirus disease by openly sharing knowledge and offering free access to relevant standards, guidance and training.
Full details are available in the EDQM 2020 annual report.
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.Read more 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.
Full details are available in the EDQM 2019 annual report.
The year 2018 was another productive year for the Ph. Eur. Commission, a testament to its commitment to keeping abreast of new scientific developments and anticipating the need to create standards in 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 Working Party paved the way for future developments of the Ph. Eur. in this area.Read more The interest that the work of the Ph. Eur. Commission generated beyond its 39 signatory parties in 2018 was demonstrated again by the Republic of Uzbekistan’s request for observer status to the Commission, which was granted during the March 2018 session.
International co-operation remained a priority throughout the year. Much progress was made across the EDQM’s different healthcare activities: the 7th edition of the Guide to the quality and safety of organs for transplantation with updated information was published in 2018 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, the 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 Ars-Laquenexy (near Metz, north-eastern France) in June. This new site will store contingency stocks of the EDQM’s portfolio of over 3 000 pharmaceutical reference standards and ensure 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.
Full detail is available in the EDQM 2018 annual report.
The European Pharmacopoeia Commission made major progress in the field of biotherapeutic products and animal protection in 2017. In particular, the first monograph on a monoclonal antibody (mAb): Infliximab concentrated solution (2928) was adopted, marking an important milestone in relation to biotherapeutic products.Read more
Following the decision to suppress completely the test for abnormal toxicity from the Ph. Eur., 49 monographs were revised, including 36 monographs on vaccines for human use. The Republic of Moldova became a member of the Ph. Eur. Commission in April, bringing the number of signatories to the Convention on the Elaboration of a European Pharmacopoeia to 39 (38 member states and the European Union). In terms of international relations, memorandums of understanding were signed with ANVISA (the Brazilian Health Regulatory Agency) and the Chinese Pharmacopoeia Commission.
On the healthcare side, the EDQM made progress in securing the safety and quality of blood transfusions in Europe by providing continuous support to European blood establishments (BEs) in the implementation of key aspects of ensuring the optimal use of blood and the protection of both donors and recipients, such as quality management, risk management, change control, and validation and qualification. The EDQM also published the 3rd edition of its Guidelines on the quality and safety of tissues and cells for human application. In the field of cosmetics, a new guide on safer tattooing provided an overview of current knowledge and challenges in the toxicological assessment of inks for tattoos and permanent make-up.
Full details are available in the EDQM 2017 annual report.
The year 2016 saw the publication of the 9th edition of the European Pharmacopeia and the election of a new Chair and two new Vice-Chairs to the Ph. Eur. Commission.
The Ph. Eur. Commission also revised its working procedures to open up to nominations for its Groups of Experts and Working Parties to experts from states that are neither members of nor observers to the European Pharmacopeia.
India and Japan were both granted observer status and the Ph. Eur. Commission concluded its P4Bio pilot phase which resulted in the successful publication of five drug substance monographs.Read more
The EDQM and Japanese Pharmaceutical Safety and Environmental Health Bureau of the Ministry of Health, Labour and Welfare (MHLW) signed a five-year Memorandum of Cooperation and agreed terms for sharing information related to active pharmaceutical ingredients of interest to both Europe and Japan. The EDQM also became an observer to the International Council for Harmonisation (ICH).
Two new resolutions on good reconstitution practices in health care establishments and the quality and safety of medicines prepared in pharmacies for the special needs of patients were adopted by the Committee of Ministers of the Council of Europe. The European Commission adopted the Council of Europe’s Good Practice Guidelines for blood establishments as a legal instrument in the EU, via its Directive (EU) 2016/1214. Albania, Armenia, Belgium and France ratified the MEDICRIME Convention.
The EDQM revised its roadmap for electronic submissions of Certificates of Suitability (CEP) applications and issued guidance on the implementation of ICH Q3D on elemental impurities in the CEP Procedure.
Other publications released included the 6th edition of the Guide to the quality and safety for organs for transplantation and two booklets for the general public, “Umbilical Cord Blood Banking. A Guide for the Parents and “Exercise your way to better post-transplant health.
Full details are available in the EDQM 2016 annual report.
The Ph. Eur. Commission adopted its first finished product monograph containing a chemically defined active substance and adopted its strategy for the implementation of the ICH Q3D Guideline on Elemental impurities.
The Republic of Korea was granted observer status to the European Pharmacopoeia Convention and the ratification of the MEDICRIME Convention by the Republic of Guinea (the fifth to date) triggered the entry into force of the convention on 1 January 2016.
Full details are available in the EDQM 2015 annual report.
The year 2014 was an anniversary year for the EDQM. It celebrated the 50th anniversary of the Convention on the Elaboration of a European Pharmacopoeia and the 20th anniversaries of both the OMCL Network and of the procedure for Certification of Suitability to the European Pharmacopoeia Monographs.
The Ph. Eur. Commission published its first monograph on a chemically-defined finished product as a draft for public inquiry in Pharmeuropa and approved, together with the Committee of Experts CD-P-PH, a project for the elaboration of a pan-European formulary for non-licensed medicines for children.
Full detail is available in the EDQM 2014 annual report.
In 2013, the EDQM Laboratory was accredited as ISO/IEC 17025:2005 compliant and the ISO 9001:2008 certification was extended to cover the conduct of laboratory studies. The 8th edition of the Ph. Eur. came into force and South Africa and the Taiwan Food and Drug Administration (TFDA) were granted observer status to the European Pharmacopoeia Convention. Spain ratified the MEDICRIME Convention and the OCABR Network was enlarged to welcome Canada and Israel.
The 1st edition of the Guide to the quality and safety of tissues and cells for human application was published, along with several new publications on combatting falsified medical products and related crimes.
Full detail is available in the EDQM 2013 annual report.
In 2012, the eTACT project, the EDQM’s anti-falsification traceability service for medicines, was launched. Ukraine became both the first country to ratify the MEDICRIME Convention and the 38th member of the European Pharmacopoeia Convention, and the Republic of Guinea and Singapore were granted observer status.
The ISO 9001:2008 certificate was extended to cover the management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format, and their distribution.
Full detail is available in the EDQM 2012 annual report.
On 24 June 2011, the EDQM signed a trilateral Memorandum of Understanding (MoU) with the State Administration of Traditional Chinese Medicine of the People's Republic of China (SATCM) and its National Key Institute of TCM Quality Control (NKI-TCM).
The ISO 9001:2008 certificate was extended to the market surveillance of finished medicinal products and issuance of guidelines for the release of human immunological and blood derivative medicinal products.
Full detail is available in the EDQM 2011 annual report.
Memorandums of Understanding were signed with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC).
The EDQM took over responsibility for the establishment, preparation, storage and distribution of WHO International Chemical Reference Substances (ICRS).
Full detail is available in the EDQM 2010 annual report.
More of the EDQM's history