Press release - New approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs) - October 2019
During its 164th session on 18 June 2019, the European Pharmacopoeia Commission adopted 43 texts related to its new approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs). The new approach constitutes a move away from the description of detailed methods towards greater flexibility and allowing tailoring to individual product needs. From starting material to final product, users will now have to follow an overall risk-management approach to ensure they apply the best testing strategies in the context of a consistent manufacturing process.
Press Release - European Pharmacopeia 10th Edition: continuous updates to address new challenges - September 2019
The newly released 10th Edition of the European Pharmacopoeia, contains 2 420 monographs and 373 general texts (including general monographs and methods of analysis), as well as around 2 780 descriptions of reagents. In total, 114 new monographs have been introduced*1, of these 17 concern active substances of high medical interest covering key therapeutic classes, such as antineoplastics, immunosuppressants, anti-arrhythmics, anti-thrombotics, antiretrovirals or analgesics; and 7 monographs concern finished products containing chemically defined active substances.
Press Release - EDQM conference addresses key issues and work priorities for tomorrow’s medicines - July 2019
The international conference “EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines” took place on 19 to 20 June 2019 in Strasbourg to mark the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th Anniversary of the European OMCL Network and of the Certification of Suitability Procedure. The plenary sessions and workshops at the conference were attended by more than 300 participants from 47 different countries in Europe and beyond, including, Brazil, Canada, China, India, Japan, Kazakhstan, Senegal, South Africa, the Taiwan Food and Drug Administration (TFDA) and the United States of America (USA).
Press Release - 164th Session of the European Pharmacopoeia Commission (18 June 2019) - July 2019
Following the election of its new Chair, Prof. Torbjörn Arvidsson, at its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Salvador Cañigueral as its first Vice-chair and Mr Goran Benkovic as its second Vice-chair, for a term of three years. The Presidium, which consists of the Chair and the two Vice-chairs, assisted by the Director of the EDQM and the Secretary to the Commission, will support the Ph. Eur. Commission in defining criteria for prioritisation of its work and establishing a set of priorities for the coming three years.
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.