Last week’s round-up, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


Delays in treatment of requests for revision and renewal of CEPs

03 Oct 2019

The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications.

The delay is currently about 5 weeks and the EDQM has assured applicants that it is making every effort to improve the efficiency of the process in order to decrease the current delays. Therefore, applicants should adjust their planning around the regulatory activities involving CEPs and any CEP holders intending to submit any revision/renewals in the later part of 2019 should also be aware and plan regulatory activities accordingly. Barring unforeseen events, the delays are expected to last until the end of 2019. For more details, please see:


Ireland’s ambitions and innovation for drug and research development

02 Oct 2019

Ireland is striving to become a centre of excellence for research, development and innovation in drug development by 2020.

This article, written by consultants from our sister company Real Regulatory, reviews related progress within the country, particularly when it comes to clinical trials. Ireland is increasingly being sought out in this area due to its size, which makes it “small enough to trial, large enough to prove”.

The country’s current clinical trial infrastructure and plans under the upcoming EU Clinical Trial Regulation are reviewed, together with Ireland’s national scientific advice procedure and innovation office:


Letters sent to industry outlining how to convert marketing authorisations.

01 Oct 2019

The MHRA have updated their guidance on the conversion of community marketing authorisations to UK marketing authorisations in the case of a no-deal Brexit.

The update involves the publication of three new letters sent to industry on the topic. The letters ask marketing authorisation holders to advise the MHRA of any new EU product licenses or new presentations to an existing product since 29 March 2019, so that the MHRA will be able to assign associated UK Product License numbers.

The letters also remind MAHs to review the lists of centrally authorised products previously sent to them by the MHRA on 2nd January 2019. MAHs should notify the MHRA should they wish to opt-out of the automatic grandfathering process for any product and should also designate a single point of contact for their products. In the case of centralised applications that are still pending on exit day, an application manager will be assigned to each, with priority given to those at the later stages of assessment:


Guideline on sterilisation published by EMA

30 Sep 2019

Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container.

The EMA has published a guideline, which will come into force 1st October 2019, on the choice of sterilisation method, the development data and manufacturing data required to demonstrate the suitability of the selected sterilisation process for medicinal products, active substance, excipients and primary containers. The article provides guidance on the information expected to be contained in the quality dossier and information on GMP certificates. For more details, please see:


Image: irish_flag, CC BY 2.0

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