Press Release - OMCL Network discusses strategy and reviews past year’s activity at annual meeting - June 2019
The 24th annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place on 13-17 May in London (UK). It was attended by 260 participants from 40 countries, representing 61 OMCLs and national competent authorities, including representatives from the official laboratory at the Medicines and Medical Devices Agency of the Republic of Moldova, which joined the Network as a full member in July 2018.
Press Release - Pharmacopoeial Discussion Group - April 2019
Pharmacopoeial Discussion Group videoconference meeting
Press release - Outcome of the 163rd Session of the European Pharmacopoeia Commission - March 2019
During its 163rd session, held in Strasbourg on 19-20 March 2019, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Torbjörn Arvidsson (Sweden) as its Chair. As the 19th Chair of the Ph. Eur. Commission since its establishment in 1964, Prof. Arvidsson will be supported by two Vice-chairs who will be elected in June. Together they will guide the work of the Commission for a term of three years, from June 2019 to June 2022.
Press release - Joint EDQM-USP symposium - March 2019
Joint EDQM-USP symposium illustrates use of pharmacopoeial reference standards Established specifically for their intended use, pharmacopoeial reference standards are thoroughly characterised and their uses may go beyond those described in compendia, although a clear-cut distinction between quantitative use and qualitative use is essential. For example, compendial assay standards for APIs may be used for assay of finished products as long as specific criteria are fulfilled, as stated in chapter 5.12 of the European Pharmacopoeia (Ph. Eur.).
Press release - 20 years of sampling & testing programme for medicines authorised for the EU - March 2019
20 years of sampling & testing programme for medicines authorised for the EU The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the European Medicines Agency (EMA) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.
Press Release - EDQM and EU Commission discuss improving plasma supply management and donor protection - February 2019
The EDQM and the European Commission (EC) brought together stakeholders involved in the field of plasma to discuss ways forward for improving plasma supply management and donor protection, during a symposium organised in Strasbourg on 29 and 30 January 2019. As emphasised by those present at the meeting, this was the first time that all stakeholders in the sector had met to exchange their views on how to increase the supply of plasma for fractionation in Europe, while ensuring adequate protection of both donors and patients.
Press Release - EDQM welcomes WHO recommendation to discontinue innocuity test - December 2018
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents.
Press Release - Outcome of the 162nd Session of the European Pharmacopoeia Commission - November 2018
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts.
Press Release - Ph. Eur. Modification General Section 3 - November 2018
The European Pharmacopeia (Ph. Eur.) includes a Section 3. on materials for containers (Subsection 3.1) and containers (Subsection 3.2). For historical reasons, the general chapters of this Section 3. include texts on primary packaging, as well as on medical devices.
Press Release - Public Consultation for Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2) - November 2018
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on two major texts for the testing of parenteral drug products. The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for injection, infusion or implantation. The monograph has been modernised to meet current testing requirements e.g. for (sub-)visible particles, bacterial endotoxins, uniformity and release, particularly as applied to liquid parenteral preparations.