Last weeks round-up; 9 – 13 March 2020

EMA UPDATE: GUIDANCE ON THE PILOT FOR SIMULTANEOUS NATIONAL SCIENTIFIC ADVICE

EMA has issued an update to the guidance for applicants for the pilot simultaneous national scientific advice (SNSA) process, which is now live. The changes do not look to be anything more than formatting edits (please correct us if we are wrong). So perhaps they are trying to increase the uptake. The process itself is well described in the document which can be found under this link https://lnkd.in/d76bDmG

EMA NEWS: VIRTUAL EMA MEETINGS UNTIL END OF APRIL 2020

In order to limit international travel and the number of visitors going to the offices, and to reduce the risk of an infection with the novel coronavirus for delegates, visitors and staff, EMA has advised that all meetings of EMA committees and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA which were planned to take place at the Agency’s premises in Amsterdam in March and April will either be held virtually or postponed until later in the year. Participants of these meetings will be informed directly about this decision. EMA’s plans are being continually reviewed. The dedicated webpage on COVID-19 is updated as the situation develops. https://lnkd.in/dx4cjB3

Last weeks round-up; 27 – 31 January 2020

EMA HAS ISSUED GUIDANCE FOR APPLICANTS ON A PILOT SCHEME FOR SIMULTANEOUS NATIONAL SCIENTIFIC ADVICE (SNSA)

Companies seek national scientific advice to optimize prospectively their development programme. Scientific advice (SA) can be received nationally from national competent authorities (NCAs), or centrally coordinated by EMA. Experience has shown that national advice is quite often requested from more than one NCA. In order to optimize resources on both sides and improve the regulatory support, a new approach has been developed: in one single step national scientific and/or regulatory advice can be requested with two NCAs simultaneously (SNSA). The objective is to establish a more efficient procedure for applicants seeking advice for the same set of questions and data package from different NCAs based on the existing principles and structures. Thus, the new approach is envisaged to be a complementary tool to the established regulatory/scientific advice procedures at national or European level without duplicating existing advice procedures.

For more details of the scheme and how to participate please follow this link; https://lnkd.in/d76bDmG

GENERAL COURT OF THE EU: THIRD PARTY ACCESS TO CLINICAL TRIAL DATA

In a decision made by the General Court of the European Union, it was determined that clinical study reports are not covered by the general presumption of confidentiality. While edits are to be made by the EMA in order to protect sensitive commercial data prior to sharing, it is the responsibility of the marketing authorization holder to provide a detailed explanation of why sharing CSR data would pose a threat to their commercial interest. For more information, please see the following link: http://bit.ly/2Rm4lzF

ENPR-EMA NEWS: EUROPEAN NETWORK FOR PEDIATRIC RESEARCH AT EMA HAS ISSUED THEIR 2019 NEWSLETTER

Enpr-EMA has issued details of the progress made by the various working groups during 2019. The headline topics include publication of draft framework on trial preparedness, bringing together regulators of several regions working on guidance related to clinical trial applications, an inaugural meeting of an Enpr-EMA research nurse group, and guidance on informed consent / assent. Further details can be found on the newsletter under this link https://lnkd.in/dRaNHjG

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