All Regulatory Rapporteur articles in October 2023
View all stories from this issue.
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PodcastsRegRapPod − October 2023
Vol.20 #9: In the October 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Kornelia Grein about veterinary medicines.
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JournalPrequalification of veterinary vaccines and medicines
An initiative to assure the quality of veterinary medicinal products for use in animal health programmes to support humanitarian assistance.
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JournalTransition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...
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EditorialVeterinary medicines: the challenges of new regulation
Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...
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JournalOptimal materials selection in medical device development – a proactive biocompatibility approach
Regulatory Rapporteur October 2023 | Volume 20 | No.9 Introduction Biocompatibility evaluation of medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the ...
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JournalEMA activities related to antiparasitic veterinary medicinal products
Antiparasitic medicines rightly play an important role in veterinary medicine, as antiparasitic diseases can have important impacts on animal health and welfare and are economically significant. Antiparasitic veterinary medicinal products (VMPs) are evaluated under the same thorough licensing procedure as all other veterinary medicines before they are authorised, and are ...
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JournalAutogenous vaccines under Regulation (EU) 2019/6
Through Regulation (EU) 2019/6, it has been the first time that so-called autogenous vaccines (AVs) are included in the EU legislation that rules veterinary medicinal products. Described as inactivated vaccines which are manufactured from pathogens obtained from animals in an epidemiological unit, they are restricted to the ...