News

Last weeks round-up; 14 – 18 October 2019

published 22 Oct 2019

EVALUATION OF THE EU BLOOD, TISSUE AND CELLS LEGISLATION

On 11 October 2019, the European Commission published its evaluation of the EU blood, tissues and cells legislation. An executive summary is also available. This was the first evaluation of the legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). Further information and a link to the evaluation can be found under this link https://lnkd.in/ds48XHY. The results of the evaluation will be disseminated at a Conference in Brussels on 28 October 2019.

EMA: UPDATED VERSIONS OF eAFs NOW AVAILABLE

EMA has just issued version 1.23.1.3 of the 4 electronic Application Forms (eAF), which are now available on the eAF website, along with new release notes and a release milestone plan. This release is a bug fix release to correct a number of issues which affect the forms. The bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure. https://lnkd.in/de7AFKu

PAEDIATRIC COMMITTEE (PDCO) MEETING MINUTES

An overview of Pedmed-NL (the former Dutch Medicines for Children Research Network) was presented. The network has been involved in the development of the Dutch Paediatric Formulary (kinderformularium), the establishment of European Paediatric Translational Research Infrastructure (EPTRI) and Paediatric Clinical Research Infrastructure (PEDCRIN) as well as in the planning of clinical trials, mainly via Connect4Children (C4C). The network was relaunched in 2018 as PedmedNL with main goal to facilitate and support the conduct of C4C proof of viability studies (by 2023). The main goal beyond 2023 is to create a sustainable network for research in children. The minutes can be found under; https://lnkd.in/dpNCPqQ

UK WITHDRAWAL FROM EU: EMA RELOCATION TO AMSTERDAM

EMA has recently reported a further 6% reduction in workforce as a result of relocating to Amsterdam. As a result EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network further details can be found here: https://lnkd.in/dx49VpY

EMA ADVISES COMPANIES ON STEPS TO TAKE TO AVOID NITROSAMINES IN HUMAN MEDICINES *UPDATE*

As previously advised, EMA has requested all EU marketing authorisation holders of medicinal products containing chemically synthesised APIs to review their medicines within the next 6 months for the presence of nitrosamines. Real Regulatory has both the expertise and resource to support this review process. For more information on the EMA recommendation, including a Q&A quide: https://lnkd.in/erne7TZ

EMA PRIME ELIGIBILITY REQUESTS

EMA has just published its deadlines and timetable for PRIME Eligibility request assessments for 2020. Further details can be found here; https://lnkd.in/d7Z8x6J