Regulatory & compliance

ANSM launches public consultation on advertising of medicinal products to public

Audrey Aboukrat

The French medicines regulator (ANSM) recently launched a public consultation concerning the warning message that pharmaceutical companies must include in all audio-visual advertising of medicinal products to the public, as part of the mandatory information required for medicine advertising by Articles L. 5122-6 and R. 5122-3 of the French Public Health Code.  The consultation concerns Read More

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

Daniel Lim

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the question of human germline genome editing: At this time, given the nature and number of unanswered scientific, ethical, and Read More

EMA ensures business continuity while preparing for Brexit

Audrey Aboukrat

In the beginning of August, the EMA issued a press release on the functioning of its business continuity plan to deal with the uncertainty and workload implications linked to Brexit. The plan, which was developed after the UK referendum and endorsed by the EMA Management Board in June 2017, aims at ensuring that the assessment Read More

Majority of invented names for medicinal products rejected

Eveline Van Keymeulen

In 2016, more than half of the proposed invented names for centralised medicinal products were rejected (246 rejections to 241 acceptances), and this trend continues in the first half of 2017. Invented names for centralised medicinal products are reviewed by the Name Review Group (NRG) of the European Medicines Agency (EMA), which meets approximately every Read More

France envisages joining BeNeLuxA initiative

Eveline Van Keymeulen

According to recent statements of the Dutch Minister of Health, the French Minister of Health indicated during the last meeting of the Council of the European Union that France is considering joining the BeNeLuxA initiative, the collaboration between the Belgian, Dutch, Luxembourg and Austrian governments on pharmaceutical policy. If France joins the initiative, the new Read More