Pharmaceuticals
ANSM launches public consultation on advertising of medicinal products to public
16 August 2017 - Posted by: 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
11 August 2017 - Posted by: 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
08 August 2017 - Posted by: 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
WP 29 releases an extensive opinion on data processing at work
07 August 2017 - Posted by: Inge Vanderreken
The EU’s “Article 29 Working Party” (WP29) has adopted new guidance on the processing of personal data in the employment context (the New Opinion). This New Opinion complements their 2001 opinion and 2002 working document. WP29 is the Data Protection Working Party established by Article 29 of Directive 95/46/EC. It is an independent European advisory › Read More
Majority of invented names for medicinal products rejected
04 August 2017 - Posted by: 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