News

Last weeks round-up; 27 – 31 January 2020

published 3 Feb 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