The development of bioequivalence guidelines in North Africa region started years ago yet considering the political issues, localization and the lobbying of the local manufacturers the issuance and the implementation was delayed. It was recently that Tunisia health authority issued the guidelines and shared the phases for the execution. As for Algeria, till today, it is not obligatory to submit a bioequivalence study (BE) for local manufacturers and so far no official guidelines have been issued. As for Morocco and with reference to the attached official gazette which states that starting from Jan,2020 all industrial pharmaceutical establishments that commercialize generic medicine in Morocco without BE studies or have submitted files under assessment starting from March,2019 should complete the application for five years renewal by submitting BE Study. This what was published in March, 14.  

The consequences of this decree is major since it is not affecting only the new submissions and the products in the pipeline but also the existing registered and marketed products. Never the less it also opens the opportunities to invest to establish CORs in Morocco since this is a new area for business to be explored. 

On the other side and with reference to this movement there has been arrangement for the first Bioequivalence conference in Morocco which will be held in Rabat during the period of March,28 to March,29 -2019 so as to share and experts opinion from EMA and EU region, the middle east health authorities experience in establishing and implementing the guidelines in addition to the industry voice and expected risks/challenges to be faced in the future. 

The agenda for the conference has been attached for your reference.