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News | 04 March 2021 | Strasbourg, France
The EDQM announces the availability of 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 30 replacement batches for Ph. Eur. reference standards.
News | 23 February 2021 | Strasbourg, France
The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were published on 13 November 2020 on the EMA’s website. The revision concerns a rewording of the “Production”...
News | 21 January 2021 | Strasbourg, France
The new Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 168th session in November 2020.
News | 06 January 2021 | Strasbourg, France
All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 2021.
News | 04 January 2021 | Strasbourg, France
The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 10 replacement batches for Ph. Eur. reference standards in December 2020.
News | 04 January 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.5 is now available and will be applicable in 39 European countries as of 1 July 2021.
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).
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 | 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 | 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...