R104 - Moroccan Good Regulatory Practices – Regulatory and Technical Requirements for the Registration of Medicines for Human Use in Morocco

Good Regulatory Practices are internationally recognised processes, systems, tools and methods for improving the quality of regulations. As specified by WHO, GRP aims at making sure that regulations are fit for purpose and will deliver what they are set out to achieve in terms of policy objectives. In this presentation we will review the pyramid of Moroccan legislative texts and Moroccan pharmaceutical regulations since the creation of the Moroccan pharmaceutical authority represented by the Directorate of Medicines and Pharmacy. Moroccan pharmaceutical authority adopt policies that promote regulatory convergence and harmonization (directives of WHO, ICH, EMA...), therefore, it is member of OMCLs (European Official Medicines Control Laboratory), USP associate member and European pharmacopoeia observer member. Despite the fact that the Moroccan authority has made progress in the documentary assessment of biological and biosimilar drugs, it considers that great efforts are necessary to deploy within the framework of the analytical control of these drugs and to frame the so-called drugs of the innovative therapy, namely cell therapies and gene therapies. To increase its level of competence and mastery of the drug market, the DMP has set up a new biotechnology laboratory for the analytical control of biosimilar, biotechnologies drugs and vaccines in the context of a registration and in post-marketing surveillance. The bioassay laboratory, is part of the units of the new biotechnology laboratory.