Last week’s round -up;
01-05 February 2021

published 8 Feb 2021

Pharmeuropa updates

The following draft revised monographs (with tracked changes) have been published in Pharmeuropa. The draft monographs are available for public consultation until 31st March 2021.

· 2.9.2 Disintegration test for solid rectal and vaginal dosage forms

· 2.9.5 Uniformity of mass of single-dose preparations

· Vaginal preparations

The revised monographs can be seen at the following link:

EMA News:  EMA announces detail approach on training for the new Clinical Trial Regulation CTIS portal.

In anticipation of CTIS go-live in Dec 2021 to support implementation of the CTR, online training modules are foreseen from 21st Jan to ensure equal access for all. Once launched, CTIS will be immediately available for authorities and clinical trial sponsors, with a 3 year phased transition period from the current Directive 2001/20/EC. EMA plans 3 training streams

1. Creation of Sponsor Master Trainers;

2. micro/SME, academia and other non-commercial sponsors; and

3. Targeting different forms of end-users on role specifics (e.g. admin, preparer, submitter).

Real Regulatory has SME status and will initially train on the 2nd stream. Training and our current involvement in pilot schemes now available will mean we can continue to provide best support to our clients.

Full details can be found here:

EMA News:  EMA has issued a new draft guidance on the Module 3 quality support packages required for MAAs of PRIME Designated Medicines.

PRIME was launched to enhance EMA support to the development of medicines that target an unmet medical need. EMA has just published a draft guidance on scientific elements and regulatory tools to support quality data packages for applications to the scheme. This should serve as a toolbox for building Module 3 quality data packages in the preparation of marketing authorisation applications (MAAs) of designated PRIME medicinal products.

The document in full can be found her:

EMA News:  EMA has published detailed accelerated assessment timetables for ATMP full MAAs

The EMA has published a new document which details timetables for full MAA procedures for Advanced therapy medicinal products (ATMPs). Timings extend through to end of 2024, and include assessment of the initial submission (120 day timetable) and timings for assessment of responses to list of questions (30 day timetable after clock-stop).

The document can be found here: 

UK MHRA updates Pharmacovigilance System requirements

Following user feedback, the MHRA have edited some of their guidance on Qualified Person responsible for Pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF) to make it easier to understand and to provide clarification on certain points. The updated guidance can be found here:

UK MHRA publishes the submission dates for the new UK national MAA 150-day procedures

Marketing Authorisation Application submission dates for the new 150-day national and European Commission decision reliance procedures and guidance on how submissions using the EC decision reliance procedure work have been published on the MHRA website, and can be found here: 

Updates from the EDQM

The EDQM has recently released the ‘New European Pharmacopoeia Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances’.

The Directorate has also released the following updates:

• Nitrosamines – Update from the CEP procedure (16-Dec-20)

• European Paediatric Formulary: Phosphate Oral Solution open for public consultation in issue 3 of Pharmeuropa PaedForm (17-Dec-20)

• European Pharmacopoeia Supplement 10.5 now available (04-Jan-21)

• European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26) (05-Jan-21)

• Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments (06-Jan-21)

• Brexit: End of mutual recognition of Official Control Authority Batch Release between the EU/EEA and the UK (08-Jan-21)

• Adoption of Fritillariae thunbergii bulbus describing alternative quality control test (15-Jan-21)

• Implementation of the European Pharmacopoeia Supplement 10.5 – Notification for CEP holders (18-Jan-21)

• CEP holders invited to comment on draft monographs published in Pharmeuropa 33.1 (20-Jan-21)

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