News

Last weeks round-up; 30 March – 3 April 2020

published 6 Apr 2020

EMA ADOPTS ICH GUIDELINE S11 ON NONCLINICAL SAFETY TESTING IN SUPPORT OF DEVELOPMENT OF PAEDIATRIC PHARMACEUTICALS

EMA has adopted the ICH S11 guideline. It is due to come into effect on 26th September 2020. The guideline provides direction on the nonclinical safety studies important to support a paediatric development program. It will recommend standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides guidance on the design of the studies. A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals will be achieved with the implementation of this new harmonised ICH guideline. The full text can be found here https://lnkd.in/dbkTrr2

EMA BIOLOGICALS WORING PARTY (BWP) HAS PUBLISHED ITS RECOMMENDATIONS FOR THE SEASONAL INFLUENZA VACCINE COMPOSITION FOR 2020/2021 SEASON

The BWP was convened in order to recommend the virus strains for the manufacture of seasonal influenza vaccine for 2020/2021. Having considered the information on international surveillance by WHO presented by the representative of the WHO Collaborating Centre for Reference and Research on Influenza at the Francis Crick Institute (UK), the CHMP BWP Ad hoc Influenza Working Group, consisting of experts on influenza from the Member States, considered that the WHO recommendation on the composition of vaccines for 2020/2021 should be followed. The recommendations can be found under this link https://lnkd.in/dSgTVp4

EMA: FEES INCREASE 1ST APRIL 2020

The EMA has announced that general fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on 1 April 2020. Full details of the new fee levels are available in Commission Regulation (EU) No 2020/422 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published on 19 March 2020. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures. Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2019, as published by Eurostat, the EU’s statistical office. https://lnkd.in/eJFEjHQ

ICH: EC AND EMA IN COLLABORATION WITH EU MEMBER STATE, ADEQUATELY IMPLEMENT AND ADHERE TO  ICH GUIDELINES

ICH has issued the results of a survey, which show that the EC and EMA, in collaboration with EU Member States, adequately implement and adhere to ICH guidelines, without introducing unjustified modifications: Adequacy of Implementation and Adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines: centralised procedure with EMA. https://lnkd.in/eiAUGbb These results are part of a 2019 study to monitor the adequacy of implementation and adherence to ICH guidelines in regulatory member and observer countries and regions. The study report provides a gap analysis based on authorities’ and companies’ views on the implementation and adherence of regulators to ICH guidelines. It reveals a close alignment between the self-declaration of the authorities and perception among companies. For more information, see ICH guideline implementation on the ICH website. https://lnkd.in/efGNCwZ

EMA: ADVANCING REGULATORY SCIENCE IN THE EU: NEW STRATEGY ADOPTED

EMA has published its Regulatory Science Strategy to 2025 on 31st March 2020. It comes in response to the dramatic acceleration of the pace of innovation and the need to support the development of increasingly complex products, especially in the light of the ongoing COVID-19 pandemic. One of the fundamental principles of the strategy is the need for rapid and close engagement of all stakeholders and partners. The learnings from the handling of this public health crisis will be incorporated in ongoing adaptations in real-time. The five key goals of the strategy include: catalysing the integration of science and technology in medicines development; driving collaborative evidence generation – improving the scientific quality of evaluations; advancing patient-centred access to medicines in partnership with healthcare systems; addressing emerging health threats and availability/therapeutic challenges; enabling and leveraging research and innovation in regulatory science. https://lnkd.in/gXXxV2r

HPRA – APPLICATION BY A MANUFACTURER FOR A REGULATORY DEROGATION FOR A NON-CE MARKED MEDICAL DEVICE FOR COVID-19

HPRA issued form ‘Application by a Manufacturer for a Regulatory Derogation for a non-CE marked Medical Device for COVID-19’ on the 24th March 2020 for manufacturer’s to apply to HPRA for permission for use of their non-CE marked medical device(s) by healthcare professionals in the context of COVID-19 outbreak. The form is intended to speed up the process of use of devices for COVID-19 and must be completed by the manufacturer or their authorized representative. The form is available from the following link https://lnkd.in/eYAjh-C

EMA TO ISSUE ELECTRONIC CERTIFICATES FOR MEDICINES

From 30th March 2020 EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. EMA will no longer provide printed certificates. This will allow the agency to maintain the ability to provide these documents during the COVID-19 pandemic. The new format of the certificates is based on an electronically signed PDF document and will apply to all ongoing and future requests. The Agency will also consider whether the electronic signature should be implemented as a permanent solution as part of its efforts to digitalise its administrative processes for all documents requiring signature. Questions on the new electronic certificates can be sent by email to: . More information on the certification of medicinal products is available on EMA’s website.