02 JULY 2018
The EDQM has released its 2017 Annual Report providing an overview of its accomplishments. Among the major highlights for the past year, the European Pharmacopoeia (Ph. Eur.) Commission kept on ensuring that the monographs and texts of the Ph.Eur. stay abreast of scientific and technological progress and achieved considerable progress in the field of biotherapeutic products. For example, the adoption of the first monograph on a monoclonal antibody (mAb): Infliximab concentrated solution (2928), was a major milestone in the quality control of biotherapeutic products, paving the way for the future work of the Ph. Eur. Commission on therapeutic mAbs.
In line with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, the Ph. Eur. Commission decided to completely remove the test for abnormal toxicity from the Ph. Eur., another major achievement in terms of implementing and promoting animal welfare in quality control testing in Europe.
Cooperation with international partners also featured high on the EDQM agenda last year. Two Memorandums of Understanding on co-operation in the field of medicines’ quality and on pharmacopoeial standards were signed with ANVISA, the Health Surveillance Agency of Brazil. A Memorandum of Understanding was also signed with the Chinese Pharmacopoeia Commission to promote co-operation on the safety and quality of medicines in both Europe and China.
At European level, the EDQM went on to strengthen its continued cooperation with the European Union and its European Medicines Agency, while it continued to lead the work of the European Network of Official Medicines Control Laboratories with a view to ensuring mutual recognition of test results, harmonisation of working methods and sharing of expertise, laboratory resources and data.
In the area of healthcare, the EDQM kept supporting European Blood Establishments in implementing Quality Management elements, an essential approach to ensure the optimal use of blood, as well as the protection of blood donors and recipients across Europe. The EDQM also released the 3rd Edition of the guidelines for the quality and safety of tissues and cells for human application, as well as a new guide on safer tattooing, which provides an overview of current knowledge in the toxicological assessment of inks for tattoos and permanent make-up.
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发表于 2018-7-4 09:50:28
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