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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).
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.
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).
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.
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.
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).
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.
News | 18 November 2020 | Strasbourg, France
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the EDQM offices from 23 December 2020 (12 noon CET) to 4 January 2021 (8 a.m. CET).
News | 13 November 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 12 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are...
News | 09 November 2020 | Strasbourg, France
The EDQM announces the availability of: 8 new European Pharmacopoeia (Ph. Eur.) reference standards and 24 replacement batches for Ph. Eur. reference standards.
News | 05 November 2020 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 32.4.
News | 03 November 2020 | Strasbourg, France
A broad range of technologies are being evaluated in the development of COVID-19 vaccines, from conventional approaches, such as live attenuated and inactivated vaccines, to more recent technologies, such as nucleic acid vaccines and recombinant viral vectored vaccines. Currently, limited guidance is available covering the quality of such new technologies.
News | 30 October 2020 | Strasbourg, France
In the context of the COVID-19 pandemic, the availability of quality medicines is more important than ever. Unfortunately, since the start of the sanitary crisis, shortages of medicines have increased around the world, and notably of those to treat or alleviate COVID-19 symptoms or used in intensive care units (ICUs). In addition, a number of clinical trials are under way around the world, using...
News | 27 October 2020 | Strasbourg, France
On 21 October 2020, Switzerland ratified the Council of Europe Convention against Trafficking in Human Organs, also known as the Santiago de Compostela Convention. The convention will enter into force in the country as of 1 February 2021. This legal instrument identifies various activities constituting human organ trafficking that ratifying member states must consider as criminal offences. By...