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 | 22 February 2021 | Strasbourg, France
This webinar is intended to support users and stakeholders in the swift implementation of the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C by answering the following questions: What conditions need to be met? What needs to be verified? Is validation required? What needs to be done when using recombinant factor C (rFc) instead of LAL? What is an...
News | 08 February 2021 | Strasbourg, France
The European Pharmacopeia (Ph. Eur.) regularly updates its dosage form monographs and related general chapters to ensure that they continue to reflect current practices and scientific progress. Pharmeuropa 33.1, this quarter’s issue, therefore features the revised Uniformity of mass of single-dose preparations (2.9.5) which now includes specific requirements for additional single-dose...
News | 04 February 2021 | Strasbourg, France
At its 168th session in November 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted revised versions of three dosage form monographs and two related general chapters, together with one new general chapter. While the revised texts cover a large number of medicinal products including all eye and ear preparations, and all large oral tablets and capsules above 18 mm in size, the new...
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 | 15 January 2021 | Strasbourg, France
At its 168th session, the Ph. Eur. Commission adopted Fritillariae thunbergii bulbus (2588), the first monograph to describe a test for minimum content of two markers (peimine and peiminine) by high-performance thin layer chromatography (HPTLC).
News | 13 January 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de normalisation (AFNOR), via AFNOR Certification (AFAQ).
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 | 05 January 2021 | Strasbourg, France
At its 168th session in November 2020, the European Pharmacopoeia Commission adopted the new general chapter Contaminant pyrrolizidine alkaloids (2.8.26).
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 | 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.
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 | 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 | 16 October 2020 | Strasbourg, France
During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication are currently ongoing and medicinal products are also being used experimentally in clinical practice. Reference is made to the WHO information on “Clinical management of severe acute respiratory infection (SARI) when COVID-19...