Newsroom European Pharmacopoeia
PDG’s efforts to engage other ICH pharmacopoeias in the Q4B Annexes maintenance process
At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent...
New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...
Sign up today! EDQM Virtual Training Programme - Modules on Ph. Eur., RS & CEP Procedure
This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia...
New general chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published for public enquiry
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the new proposed draft chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published in this quarter’s issue of Pharmeuropa (33.2), for comment. The Ph. Eur. Commission is presently...
2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation
A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition to applying to solutions for dialysis, the European Pharmacopoeia requires this test to be...
Revised monograph Water for injections published for public comment in Pharmeuropa
The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for...
Adoption of the revised General Notices chapter
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices. Overhauled to provide greater clarity for users, the structure and content of the chapter have also been reviewed. The chapter features new additions such...
Tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances
When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.
New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).
IMWP monographs on Favipiravir and on Favipiravir tablets published for public enquiry
The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health...
Subscriptions now open for the European Pharmacopoeia 10th Edition, Supplements 10.6-10.8
The 2022 subscriptions to the European Pharmacopoeia (Ph. Eur.) are now available for sale on the EDQM WebStore. Two subscription formats are available: 1. Electronic (bilingual English/French) Users have access to the entire 10th Edition of the Ph. Eur. until 31 December 2022. For each licence...
Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only
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
Pharmacopoeial Discussion Group videoconference meetings - March 2021
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...
Essential oils: revised monograph and new general chapter in the Ph. Eur.
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).
Pharmeuropa 33.2 just released
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.
Outcome of the 169th session of the European Pharmacopoeia Commission
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 the following 9 new texts: 8 individual monographs: Nebivolol hydrochloride (2575);...
Adoption of the revised Raman spectroscopy chapter
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Their interfaces are user-friendly and they can provide essential information...
Phasing out animal testing for in-process control of veterinary vaccines: Clostridium septicum as a proof of concept
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 Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021
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...
General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs
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...