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On Wednesday 11 May 2022, our 4th Lunchwork of the year took place on the theme of nitrosamine impurities for which the regulatory deadlines are fast approaching. This event, organised around lunchtime and accessible free of charge to our ATESSIA INTELLIGENCE subscribers, brought together 70 participants from French and international pharmaceutical companies.

On this occasion, Lorraine BALIN, Senior Consultant for Regulatory and Pharmaceutical Affairs and Christelle PETIT, Director and Consultant for Pharmaceutical Affairs at ATESSIA respectively presented an overview of the European regulatory news on nitrosamines and led constructive exchanges with the participants

After a presentation of the root causes of the formation of nitrosamine impurities in medicines, the chronology of events relating to nitrosamines on a global scale from 2018 to the present day, the actions initiated in France and in Europe and their implementation methods, the impacts on the European Pharmacopoeia and CEPs, it was mainly the concrete management of a project to analyse and mitigate the risk of nitrosamines in chemical and biological medicines (new or already registered in Europe) and traditional herbal medicines (new only) that was discussed. The discussions were based on concrete cases (feedback from ANSM), from ATESSIA’s experience.

Our speakers recalled that knowledge of nitrosamine impurities was constantly evolving and insisted on the need to regularly monitor the texts issued by the health authorities on this subject, in order to take into account any new root cause of formation identified and any limit applicable to a specific nitrosamine defined by the authorities on the basis of safety data. Indeed, since 2018, health authorities have implemented various action plans in order to protect patients’ health, including a worldwide batch recall for medicines containing nitrosamines above the defined acceptable daily intake limit.

Tout en soulignant que les exigences en terme d’évaluation du risque de présence de nitrosamines ne s’appliquaient pas à ce stade aux spécialités radiopharmaceutiques, il a été rappelé que les médicaments traditionnels à base de plantes déjà enregistrés et les médicaments homéopathiques pourraient être intégrés ultérieurement dans le champ des spécialités concernées, en fonction de l’expérience acquise.

At the time of this lunchwork, pharmaceutical companies are involved in the conduct of step 2 (confirmatory testing: identification and quantification of nitrosamines actually present in the medicinal product) of the process of analysis and mitigation of the risk of the presence of nitrosamines in medicinal products of chemical and biological origin, and even for some of them in the conduct of step 3 (updating of marketing authorisations after prior validation of the control strategy by the authorities, for example : submission of a variation modifying the control specifications of the medicinal product) of this same process for medicinal products of chemical origin for which a common deadline of 26 September 2022 has been set in Europe. An additional period of time is granted for biological medicinal products (1 July 2023) for the completion of step 2 and 3.

Pending further clarification from the ANSM regarding the filing of variations to the marketing authorisation dossier, marketing authorisation holders are invited to communicate the results of the confirmatory tests and their proposals for a control strategy sufficiently in advance and to prepare their variations now so as to comply with the deadlines set to comply with the conclusions of the summary procedure according to Art5(3) of the CHMP on 26 September 2019.

ATESSIA assists its clients in the preparation, drafting and filing of variations to their marketing authorisations.


Article written by Isabelle MOUVAULT, Pharmaceutical Affairs Advisor

On Wednesday April 20, 2022, our 3rd Lunchwork of the year took place. On the occasion of this lunchtime event, accessible free of charge to our ATESSIA INTELLIGENCE subscribers and having gathered more than 70 participants from many pharmaceutical companies and DM manufacturers, we had the pleasure to welcome the LEXCASE for a presentation dedicated to the new French Quality Charter of professional practices for reimbursable products and services.

Diane BANDON-TOURRET, Associate Lawyer, Victoire STORKSEN, Lawyer, and Lucie CLOUIN-MOTHE, Director of Operations of ATESSIA, gave an update on the new obligations, the stakes and what has still to be precised, in the management of this major turning point for the practices applied to the marketing of reimbursable products and services in France, especially medical devices.

After a review of the origins of the system, the history of the difficult negotiations between the various stakeholders, and the establishment of the legal framework, the speakers discussed the current status of the work of drafting the certification guide and the timeframe for implementation.

While stressing that all the texts are not yet available and that many things remain unclear, the speakers detailed the scope, the operators and products concerned and excluded, the semantic analysis and the definition of terms and of the different roles according to the new Charter, as well as the possible financial penalties.

Although it is possible to draw parallels with the Charter applicable to medicines in France, the two systems are clearly different in many respects. This observation can be made in many areas, such as the rules for organizing visits, the for ethics and for distributing samples. In this context, the simultaneous management of two Charters, with sometimes contradictory injunctions or additional restrictive terms, is likely to become a challenge for the companies that will be subject to both systems, beyond possible inequities between competitors who, due to their product portfolios, would not be subject to the equivalent requirements.

While waiting for more details, one thing to remember is that the Charter already applies, and even if many actions can only be undertaken once the entire system has been clarified and the certification guide is not yet available, there are already applicable measures! ATESSIA can assist you in setting up and adapting your processes to comply with these new standards.

Article written by Raphaël DAUVERGNE, Regulatory and Pharmaceutical Affairs Advisor