Past News
News |
23 April 2021 |
Strasbourg, France
The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021.
News |
22 April 2021 |
Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete the test for “heavy metals” (HMs, general chapter 2.4.8) in monographs on substances “for veterinary use only”. The 16 monographs concerned have been published in Pharmeuropa 33.2 together with other new texts and technical revisions of the Ph. Eur. The deadline for comments is 30 June 2021.
News |
21 April 2021 |
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 33.2. The table below lists the substances affected by these revisions and for which a certificate of suitability to the Ph. Eur. monographs (CEP) has been granted.
News |
19 April 2021 |
Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), held videoconferences on 6 November 2020 and on 12 March 2021. WHO (International Pharmacopoeia) participated as Observer.
News |
16 April 2021 |
Strasbourg, France
The 169th Session of the European Pharmacopoeia (Ph. Eur.) Commission, held in March, saw the adoption of the revised general monograph on Essential oils (2098) and of the new chapter on Monographs on essential oils (information chapter) (5.30).
News |
09 April 2021 |
Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021.
News |
08 April 2021 |
Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News |
07 April 2021 |
Strasbourg, France
The EDQM announces the availability of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 14 replacement batches for Ph. Eur. reference standards.
News |
07 April 2021 |
Strasbourg, France
The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. In force since 12 November 2020, this key guideline presents the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR).
News |
06 April 2021 |
Strasbourg, France
The 169th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 March 2021.At this session, the Commission adopted 68 texts for publication in Ph. Eur. Supplement 10.7, including 9 new texts.
News |
31 March 2021 |
Strasbourg, France
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy.
News |
30 March 2021 |
Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has been informed that certain commercial providers of reference standards claim their key staff are former senior employees of the EDQM. To the knowledge of the EDQM, this is not the case.
News |
24 March 2021 |
Strasbourg, France
On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe), the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European...
News |
17 March 2021 |
Strasbourg, France
In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was reworded and the N-nitrosamines test section was deleted.
News |
17 March 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”...