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Focus on Regulation

Tag Archives: biotechnology

The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?

The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human medical applications or for scientific research purposes. Scope and requirements The biobank legislation

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections.  According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug