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European Pharmacopoeia / Chemicals | 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.
European Pharmacopoeia / Ph. Eur. Commission | 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).
European Pharmacopoeia / Public enquiry | 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.
European Pharmacopoeia / Herbals | 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).
Products and Services | 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.
Paediatric Formulary | 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.
European Pharmacopoeia / Monograph | 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).
European Pharmacopoeia / Ph. Eur. Commission | 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).
European Pharmacopoeia / Ph. Eur. Commission | 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.
Paediatric Formulary | 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...
European Pharmacopoeia / International harmonisation | News | 14 October 2020 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020, with WHO attending as observer. Due to the COVID-19 pandemic, the face-to-face meeting originally scheduled was reorganised as a videoconference devoted entirely to...
European Pharmacopoeia / Public enquiry | News | 02 October 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.4 is 31 December 2020.
European Pharmacopoeia / Monograph | News | 02 October 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.4 is now available and will be applicable in 39 European countries as of 1 April 2021.
European Pharmacopoeia / Public enquiry | News | 01 October 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general text on the implementation of pharmacopoeial procedures (5.26).