Council for europe portal
Language : en Search
Choose language

Newsroom

Paediatric Formulary | News | 17 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This is the fourth monograph elaborated by the PaedForm Working Party.
Patient & Consumer Protection / Cosmetics | News | 16 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published an analytical method for the determination of polar N-nitrosamines in cosmetic products, which was validated within the European Network of Official Cosmetics Control Laboratories (OCCLs).
Certification of suitability (CEP) | News | 16 December 2020 | Strasbourg, France
In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020 draws to an end, the European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes...
Cosmetics / Official Cosmetics Control Laboratories OCCLs | News | 15 December 2020 | Strasbourg, France
A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that some cosmetic products sold throughout Europe still contain excessive levels of allergy-inducing fragrances. Results showed that 7.7% of samples were non-compliant with legislative requirements due to a missing or false declaration of allergenic fragrance compounds and that 3.1% of products marketed...
Patient & Consumer Protection / Pharmaceutical care | News | 15 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a webinar illustrating the content of Council of Europe Resolution CM/Res(2020)3 on the implementation of pharmaceutical care for the benefit of patients and health services, which aims to support member states interested in implementing pharmaceutical care in Europe. In line with the above resolution,...
Reference Standard / Collection & Catalogue | News | 14 December 2020 | Strasbourg, France
To support the implementation of the newly adopted general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42., previously listed as 2.4.36.), seven reference standards have been established and are available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 14 December 2020 | Strasbourg, France
The Official Control Authority Batch Release (OCABR) network for human vaccines and the Therapeutic Goods Administration (TGA), Australia have signed a memorandum of understanding (MOU) to increase the exchange and collaboration on common activities related to batch release of human vaccines. 
European Pharmacopoeia / Nitrosamines | News | 10 December 2020 | Strasbourg, France
During its 168th Session, the European Pharmacopoeia Commission adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36). The new general chapter proposes three procedures and focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group, for which...
European Pharmacopoeia / Monograph | News | 10 December 2020 | Strasbourg, France
Over the last few years, the European Pharmacopoeia (Ph. Eur.) has been elaborating monographs on medicinal products containing chemically defined active substances, applicable to immediate-release solid dosage forms (tablets, capsules).
Transfusion / Blood Quality Management system (B-QM) | News | 08 December 2020 | Strasbourg, France
A conference celebrating 10 years of co-operation between the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) in the field of blood transfusion shed light on the challenges faced by blood establishments (BEs) in securing sustainable blood supplies and a resilient blood transfusion sector in Europe.
European Pharmacopoeia / Ph. Eur. Commission | News | 07 December 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36).
European Pharmacopoeia / Ph. Eur. Commission | News | 04 December 2020 | Strasbourg, France
The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020. At this session, the Commission adopted 114 texts for publication in Ph. Eur. Supplement 10.6, including 101 revised texts and 13 new texts.
Reference Standard / Collection & Catalogue | News | 02 December 2020 | Strasbourg, France
The EDQM announces the availability of 12 new European Pharmacopoeia (Ph. Eur.) reference standards and 9 replacement batches for Ph. Eur. reference standards.
Reference Standard / Collection & Catalogue | News | 30 November 2020 | Strasbourg, France
Starting 1 January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS. Reference standard R0250000 – Residual solvent solution class 1 CRS contains 2 controlled substances (Carbon tetrachloride and 1,1,1–Trichloroethane).
EDQM's response to COVID-19 | News | 23 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines.