Last week’s round-up;
06-10 July 2020

published 13 Jul 2020

167th session of the Ph. Eur. Commission

The Ph. Eur. Commission held its 167th session on the 23 June 2020. Due to restrictions imposed by the COVID-19 pandemic the session was held online to ensure continuity of the work of the Ph. Eur. Commission. During the session, the Commission adopted 75 texts for publication in Ph. Eur. Supplement 10.5, including 64 revised texts and 11 new texts, including a revised text on Parenteral Preparations (0520) which had been significantly modified to update the requirements for testing for visible and subvisible particles, the definitions given and the uniformity requirements. The adopted texts will come into effect on the 1st July 2021. The next session of the Ph. Eur. Commission will take place in November 2020.

EC Health Safety Committee (HSC) meeting summary report

The ECs HSC has issued a brief summary report following its recent audio meeting. In it the EC presented the revised vaccination plan blueprint for COVID-19, including major points on objectives, vaccination coverage, priority groups and number of doses needed for the EU, as well as comments received from the HSC. Other main topics included discussions on risk assessment for resurgence of the virus, exit strategies for lockdowns, impact of deconfinement measure and superspreading events.

The report can be found under this link:

Q&A on ICH M7

The EMA has released a questions & answers document on ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (step 2b). This document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities. It also provides further insight into the information that should be provided during drug development, marketing authorization applications and/or Master Files. The EMA’s questions & answers document is open for public consultation until the 3rd October 2020.

EUnetHTA launches its COVID-19 related repository of publications and outputs

EUnetHTA, the European Network for Health Technology Assessment, has just launched a repository of related material for the COVID-19 pandemic. This responds to the EC communication on “Guidelines on COVID-19 in vitro diagnostic tests and their performance”, and is linked to the database recently set up by JRC devoted to testing devices. The repository gathers publications by EUnetHTA and by HTA organisations on testing methods and devices, treatment options, and other public health measures relevant to COVID-19.

A link the repository can be found here:

EMA issues a new medicines agency network strategy to 2025.

Recognising that the current challenges we face go well beyond the remit of medicines regulation, and will need to be addressed by the EU and its Member States as a whole and individually. Learning from this experience presents an opportunity to shape the future role of medicines regulation nationally and at the EU level, and enhance the partnership approaches that we need to ensure that we are proactively positioned to deal with similar emergencies.A new European medicines agencies network strategy to 2025 has been issued by EMA setting the direction for the Network’s response. It focuses on areas such as; Availability and accessibility of medicines; Data analytics, digital tools and digital transformation; Innovation; Antimicrobial resistance and other emerging health threats; Supply chain challenges; Sustainability of the Network and operational excellence.

The document and a public consultation on the strategy have been launched on the EMA site under this link

Lapatinib product-specific bioequivalence guidance

The second draft of the EMA’s Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance is available for public consultation until the 30th September 2020. A second public consultation of the guidance is underway as the first draft was significantly revised in response to the comments received during the first public consultation.

EMA issues first edition of the Clinical Trial Information Systems (CTIS) Newsletter

As reported last week, EMA has now issued the first edition of the CTIS Newsletter as we move towards the go-live of this eagerly awaited IT system. It is envisaged to be issued on a twice yearly basis.

The newsletter in full can be found under this link

Ph. Eur. updates

The following information regarding Ph. Eur. Supplement 10.3 has been published: · The contents of the supplement. The document includes a list of new and revised texts which will be implemented by the 1st January 2021, a list of corrected texts which should be taken into account by the 31st August 2020, as well as texts whose titles have changed and deleted texts. · New reagents have been added to the list of reagents published in chapter 4 of the Ph. Eur. · Comments concerning revised texts published in Supplement 10.3. This document contains details of the technical modifications that have been made to the revised texts.

Further details concerning these Ph. Eur. updates may be viewed here:

EMA endorsement of joint statement on prioritisation of COVID-19 clinical trials

The EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Its underlying aim is to step up global collaboration, facilitation and evaluation of COVID-19 treatments. Within the statement, key characteristics of clinical trials that enable accelerated approval are described. These include robust methodology and endpoints, realistic recruitment and completion capacity, and testing of repurposed drugs or those at advanced stages of development. Treatments addressing the most severe complications of COVID-19 and those with simpler routes of administration and treatment duration are also highlighted for priority.

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