The Nitrosamine Implementation Oversight Group (NIOG) was set up (in February 2021) by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products and to provide progress updates to the European Medicines Regulatory Network Authorities. The Terms of Reference of NIOG, containing scope, membership, oganisational and administrative support, mandate and workplan are now available, click here.
_{April 14, 2021}

AIFA has recently recorded a huge increase in reports received from Citizens, Associations and Companies, of products purchased online from unauthorised channels, which have been found to be falsified or illegal. AIFA urges consumers to be wary of those offers and recommends caution when purchasing medicines online.
_{April 12, 2021}

Gianni Rezza, General Director of Prevention for the Italian Ministry of Health, explains Covid-19 vaccines: development, evaluation, approval and monitoring. #vaccines #covid19italy
_{April 12, 2021}

Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition. The MHRA announces that the UK remains a member of Council of Europe and the European Pharmacopoeia following the Brexit transition. So, products in the UK are expected to meet the standards published by the Brexit Pharmacopoeia (which are reproduced from the European Pharmacopoeia) after the transition period.
_{March 31, 2021}

Guidance on getting scientific advice from the MHRA has been updated. It concerns more information on fees, applying for Small and Medium Company status and how this status can be incorporated into the request for scientific advice.
_{March 30, 2021}

The Medical Device Coordination Group (MDCG) provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. “Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices” is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR).
_{March 26, 2021}

In February 2021, the European Pharmacopoeia revised 5 monographs on sartans containing a tetrazole ring [(Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600)]. The rapid revision process concerned a new wording of the “Production” section and the deletion of the N-nitrosamines test section. The 5 revised monographs will become legally binding on 1 April 2021.
_{March 26, 2021}

You may find here monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines:
_{March 26, 2021}

The first deadline is approaching (March 31, 2021 for chemical medicines), make sure your company is meeting compliance standards. Choose Pharma D&S as service provider! #nitrosamine #riskevaluation #pharmadesgroup
_{March 25, 2021}

Istituto Superiore di Sanità (ISS – NB 0373) is now notified under the MDR (see this document). Check the EC database of all bodies notified under the MDR:
_{March 5, 2021}