Last week’s round -up;
08-12 March 2021

EMA update on the new Clinical Trial Regulation (CTR) submission platform Go-Live

EMA has confirm that it plans to go-live with the new Clinical Trial Information System (CTIS) on 31st Jan 2022. However, the final go-live date will be six months after the European Commission confirms the full functioning of CTIS through an independent audit. CTIS will become the single entry point for submitting clinical trial information in the EU, which will be stored within the system.

Full details of the CTR and updates on CTIS training including updates on the CTIS training currently ongoing can be found here: https://lnkd.in/dm3Q7wE

Revision of CEPs referring to “sartan” monographs

Following the revision of the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoxomil and Irbesartan) via a rapid implementation procedure, which enter into force on 1st April 2021, the currently valid CEPs referring to these monographs are considered to be already in conformity with the requirements of the monographs and remain valid. CEP holders of these substances will not be contacted by the Certification Department, as per usual procedure following the introduction of a revised monograph. CEP holders may decide to revise their control strategy for nitrosamine impurities on the basis of the production statements included in the monographs. In such cases a request for a minor revision should be made according to the EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia monographs (PA/PH/CEP (04) 2, 7R corr), 4.II.2.1 Change in the specification parameters and/or limits of the final substance g) Change of a limit for a mutagenic impurity in the final substance specification according to the principles and limits of the ICH M7 guideline. http://bit.ly/RealCMC-2N9JWOM.

UK MHRA publishes new requirements for Medical Device and IVD import to Northern Ireland

The MHRA has included a new section on importer requirements in their guidance on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland. The guidance is available at the following link: https://lnkd.in/e-y2QKM The MHRA has also included a new section on customs requirements in their guidance for retailers on supplying medical devices from Great Britain into Northern Ireland. The guidance is available at the following link: https://lnkd.in/eW9b-3S

Nitrosamines update

The EMA has released the “European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines”. The document lays out the conclusions of the CHMP review and the process for detection of N-nitrosamines in pharmaceuticals. The guidance also describes the elements to consider when deciding on the best regulatory pathway and the operational and organisational aspects at regulatory authorities’ level, which includes an overview of the activities carried out by the Nitrosamine Implementation Oversight Group (NIOG). https://bit.ly/RealCMC-3rtcBNB