Last weeks’ round -up;
06-17 December 2021

published 20 Dec 2021

Ph. Eur. Commission – 171st Session Outcome

During the 171st session of the Ph. Eur. Commission, which took place in November 2021, 75 texts were adopted for publication in the 11th Edition of the Ph. Eur. These consist of 66 revised texts and nine new texts, including the following:

• Revised and harmonised (through the Pharmacopoeial Discussion Group) chapter on Chromatographic Separation Techniques (2.2.46);

• New general chapter Implementation of Pharmacopoeial Procedures (5.26);

• Revised and now harmonised monographs Paraffin, white soft (1799) and Paraffin, yellow soft (1554);

• Two new general chapters, Assay of Bet v1 allergen (2.7.36) and Microbiological examination of human tissues (2.6.39).

Change in EDQM timelines for CEP applications

As of the 1st October 2021, the EDQM launched a new IT tool to manage CEP applications. This new tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in working days instead of calendar days. This provides more clarity on deadlines for applicants, particularly when the Directorate’s offices are closed. However, to avoid disruptions in the applicants’ internal procedures, the timelines for response to requests for additional information, clarification, etc., for ongoing procedures will continue to be counted in calendar days/months.

Pediatric Clinical Trials Updates

In their annual report, the European network of paediatric research at the EMA (EnprEMA) has highlighted timelines relating to planned updates of the Pediatric and Orphan Regulation. A proposal for revision of the legislation will be published by the end of 2022, with the aim that this will be adopted between 2023-2024. The Working Group on international collaboration has also stated that two manuscripts are being drafted regarding clinical trial application approval by National Competent Authorities and Ethics Committees covering six jurisdictions. The full report can be read in the link :

Medicines repurposing – EU pilot project

Through a newly announced pilot project, EMA and national competent authorities will be offering tailored scientific advice to not-for-profit organisations and academia on repurposing an authorised medicine for a new indication. It is expected that applicant organisations would then work in partnership with, or handover to, a Marketing Authorisation Holder to generate a variation, extension, or new market authorisation application. Candidate medicines should be authorised, contain a well-established active substance, and be out of data exclusivity and market protection periods and out of basic patent/supplementary protection certificate protection. They must also target a new indication in a condition distinct from the currently authorised indication/s, in an area where important public health benefits or Union interests are likely to be achieved.

Update to EMA’s post-authorisation procedural advice for users of the centralised procedure

The EMA has emphasised the importance of site and organisation registrations in the Organisation Management Service (OMS) prior to related pre- and post-authorisation submissions for centrally authorised medicinal products. This registration became mandatory from 1st November 2021, and will constitute a validation blocking issue if not done.

Updated EMA procedural advice on classification of advanced therapy medicinal products

The EMA has revised its Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) no 1394/2007. The procedure exists to address questions on borderline classification with other areas, such as medical devices, as early as possible. The document gives guidance for the steps to be followed by the applicant and EMA for the ATMP classification, and can be accessed through the link below.

Update to the EMA’s Sponsor Handbook on the new Clinical Trials Information System (CTIS)

The EMA has included new and updated sections in its Sponsor Handbook on CTIS. Updated sections include those on the OMS registration process, user personas and organisation models, product management, transitioning from the Directive to the Regulation, and SUSARs reporting. Sections that have been newly added relate to data fields and documents specifications, and the Sandbox environment for user training and organisation preparedness. The document can be accessed through the link below.

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