Groups of experts- and working parties under the EDQM
The work in the expert groups and working parties
There are 21 groups of experts and 41 working parties under the European Pharmacopoeia (Ph. Eur.). Their members are various national independent scientific experts and ad hoc specialists from national authorities (including official medicines control laboratories, licensing authorities and inspectors), the private sector (pharmaceutical, chemical or biological industries), universities and other research institutions. In addition to the members, a secretary from EDQM and representatives from the EDQM’s laboratory also participate. The groups and parties work with the elaboration and revision of the texts and monographs for the Ph. Eur. The groups of experts cover the general scientific aspects relevant for controlling the quality of medicines and the raw materials used. Many of the groups of experts therefore work with development and modernisation of analytical methods for quality control of medicines and raw materials.
Whereas the groups of experts are permanent, the working parties are appointed for a defined period to work in-depth with specific aspects or subjects related to the areas covered by the groups of experts. The contributions from the many groups of experts and working parties and the involvement of national experts are essential to the continued elaboration and revision of the Ph. Eur.
The amount of time to allocate for the expert work very much depends on the group of experts or working party being joined. The most active groups of experts usually hold 3 annual meetings of 1,5 days. The workload in between meetings depends on the level of commitment to the group’s work. Expect to allocate time corresponding to at least 2 weeks’ work every year.
The 21 groups of experts and 41 working parties cover the following areas:
Group of Experts 1: Microbiology
Exp. gr. 6: Biological and Biotechnological products
Exp. gr. 6B: Human Plasma and Plasma Products
Exp. gr. 7: Antibiotics
Exp. gr. 9: Inorganic Chemistry
Exp. gr. 9G: Medicinal Gases
Exp. gr. 10A/B/C/D: Organic chemistry – synthetic and semi-synthetic substances
Exp. gr. 11: Organic chemistry – natural, semi-synthetic and synthetic substances
Exp. gr. 12: Dosage forms and pharmaceutical technical procedures
Exp. gr. 13A/B: Herbal Drugs and Herbal Drug Preparations
Exp. gr. 13H: Fatty oils and derivatives, polymers
Exp. gr. 14: Radiopharmaceutical Preparations
Exp. gr. 15: Human Vaccines and Sera
Exp. gr. 15V: Veterinary Vaccines and Sera
Exp. gr. 16: Plastic materials, plastic containers and closures
Exp. gr. 17: Medicinal products containing chemically defined active substances
Exp. gr. P4: Single-source active substances, excipients and medicinal products with chemically defined active substances
ALG Working Party: Allergens
ALU Working Party: Aluminium in parenteral nutrition solutions
AQbD Working Party: Analytical quality by design
BACT Working Party: Bacteriophages
BET Working Party: Bacterial Endotoxin Test
BSR Working Party: Bovine serum
CE Working Party: Capillary Electrophoresis
CEL Working Party: Cellulose
COL Working Party: Colour determination
CRB Working Party: Carbohydrates
CST Working Party: Chromatographic separation techniques
CTP Working Party: Cell Therapy Products
DIA Working Party: Dialysis
EXP Working Party: Excipient performance
EXS Working Party: Excipient Strategy
GLS Working Party: Glass Containers
GTP Working Party: Gene Therapy Products
HM Working Party: Heavy metals
HMM Working Party: Homoeopathic Manufacturing Methods
HOM Working Party: Homoeopathic Raw Materials and Stocks
HTS Working Party: High Throughput Sequencing for the detection of extraneous agents
ICP Working Party: Inductively-Coupled Plasma
INH Working Party: Inhalations
MAB Working Party: Monoclonal Antibodies
MG Working Party: General methods
mRNAVAC Working Party: mRNA Vaccines for human use
MYC Working Party: Mycoplasma
NANO Working Party: Nanomedicines
P4BIO Working Party: P4 Bio (Biologicals)
PaedF Working Party: European Paediatric Formulary
PAT Working Party: Process Analytical Technology
POW Working Party: Powder Characterisation
PRP Working Party: Precursors for Radiopharmaceutical Preparations
ROP Working Party: Rules of Procedure
SDA Working Party: Spectroscopy and Data Analysis
SIT Working Party: Second identification test
ST Working Party: Standard Terms
SUT Working Party: Sutures
TCM Working Party: Traditional Chinese Medicines
VIT Working Party: Vitamins
WAT Working Party: Water
On the website of the EDQM you can read more about the work carried out by the individual groups of experts and working parties (descriptions of each group can be found under Additional information).
Recruitment of experts
The national members of the groups of experts and working parties are nominated by the respective national pharmacopoeia authorities and are subsequently approved and appointed by the European Pharmacopoeia Commission for a period of three years. The current period is from November 2022 to November 2025. When the current period expires at the end of November 2025, new and current experts will be (re)nominated for the next three-year period.
Submission of member nominations
Proposals for the appointment of a member (experts and ad hoc specialists) to the various groups of experts and working parties can be submitted by email to the National Pharmacopoeia Authority of the Danish Medicines Agency on npa@dkma.dk.
The proposal must be sent with:
- A brief and targeted application
- A CV highlighting the qualifications relevant for the group(s)/party(ies) applied for.
- A filled in “Declaration of Interest” form
- A filled in “Nomination as expert” form or “Nomination as ad hoc specialist” form as relevant.
The forms can be requested from the National Pharmacopoeia Authority on npa@dkma.dk.
Information about the requested qualifications for the individual expert groups and working parties is provided in the "Terms of Reference and Profile for Members of Groups of Experts and Working Parties".