Last week’s round-up;
02 – 06 November 2020

published 9 Nov 2020

New FDA Guidance on Referencing Approved Drug Products in ANDA Submissions

The US FDA has published a ‘Referencing Approved Drug Products in ANDA Submissions Guidance for Industry’. The guidance provides some clarifications to potential applicants who wish to seek approval for generic medicines on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission. The FDA also provides recommendations on how applicants can accurately use these terms in an ANDA, how applicants can request FDA designation of an RLD, and how FDA selection of a reference standard may be requested. The recommendations in the document are nonbinding.

New EMA GCP Q&A on auditing of CRO subcontractors

The EMA has released a new Good Clinical Practice (GCP) ‘GCP matters’ Q&A (No. 14). In this Q&A the EMA tackles the question of whether the sponsor of a clinical trial has the right to audit the manufacturer of the IMP even if the manufacturer has been subcontracted by a CRO involved in the trial. As per the regulations found in ICH GCP (R2), Annex 13 and GMP Volume 4, Chapter 7, the EMA has concluded that from a GCP- and GMP- perspective, the sponsor of a clinical trial has the right to audit both the CRO(s) and the subcontractor(s) involved, in order to fulfil its obligation of ensuring the quality and integrity of the trial data.

New EDQM guidance on recombinant viral vectored vaccines

The EDQM has drafted a “Recombinant viral vectored vaccines for human use” document, to support COVID-19 vaccine developers currently working on vaccines that are based on this technology. This new guidance contains analytical strategy options for the control of recombinant viral vectored vaccines, which may be conducted at different manufacturing stages and can be used as an aid in building appropriate analytical strategies during the development of candidate vaccines as well as other recombinant viral vectored vaccines. The EDQM’s draft guidance is not binding and will be updated to adapt to the evolving situation and will take into account experience with new constructs or products. Stakeholders are encouraged to submit their comments and relevant data to the EDQM via: 

EUDAMED -Actors Registration Module

A new web page linked here provides information on the EUDAMED Actor registration module (EARM). It was released by the European Commission (EC) recently. EUDAMED is the IT system developed by the EC to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. It is structured around 6 interconnected modules and a public website. The EARM is the first of the 6 modules to be made available to Member States and economic operators from 1 December 2020. It enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN) which guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED). The webpage provides economic operators with all the information (including infographics) needed to register and obtain SRN. Economic operators should access this new web page to familiarise themselves with the actor registration process in advance of registration.

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