Last week’s round-up;
07 – 11 September 2020

published 14 Sep 2020

Qualification of Balances – EDQM Guidance

The EDQM has revised its “Qualification of Balances” guideline. The document is the 8th Annex to the OMCL Network Guideline “Qualification of Equipment”, and it has entered into force as of September 2020. The 8th Annex should be used in conjunction with the core guideline “Qualification of Equipment” when planning, performing and documenting the qualification process of balances. The core document contains the general introduction and Levels I and II of qualification pertaining to all types of instruments, while the 8th Annex contains a general introduction and requirements for balances (electronic – digital) used in official medicines control laboratories for physicochemical and biological tests. The revised guideline covers ultra-micro balances, micro balances, semi-micro balances, analytical balances, precision balances and technical balances.

Comparator products in studies supporting UK MAAs from 01-Jan-21

According to new guidance published on 1 September 2020, the UK MHRA will allow the use of comparator products sourced from outside Great Britain for studies supporting abridged MAAs (but not biosimilars), to avoid unnecessary repetition of bioequivalence and therapeutic equivalence studies. All EEA countries, Switzerland, USA, Canada, Australia and Japan are acceptable source countries. An applicant choosing this option must demonstrate that the non-GB comparator product is representative of the GB reference product. The nature of the analytical bridging data to be provided is described in considerable detail in the guideline. Minor differences between the comparator product and the GB reference product can be accepted, e.g. colour.

EMA Workshop on the draft guideline on registry based studies

EMA has published an agenda for their upcoming workshop on the draft guideline on registry based studies. The key objectives of the workshop are

1. To respond to key questions and requests for clarification,

2. To present stakeholders’ perspectives on the usefulness of the Guideline for registry-based studies, and

3. To present recent experience on methodological aspects of registry-based studies.

The workshop takes place on 19th October on a virtual basis, further details can be found under this link:

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