Morocco’s Health Ministry has submitted four new draft implementing texts of the Medicines and Pharmacy Code to a week-long public consultation on the government’s general secretariat portal, comprising three draft decrees and one draft ministerial order aimed at modernizing the regulatory framework.
The texts are designed to help Morocco reach maturity level 3 of the World Health Organization’s Global Benchmarking Tool, an international assessment of national medicines regulatory systems. They cover the organization of a national pharmacovigilance system, post-marketing surveillance of medicines, a revision of marketing authorization rules, and the adoption of new manufacturing and distribution good practices.
The first draft decree establishes a structured national pharmacovigilance system to detect, assess and prevent risks linked to medicine use, entrusting coordination to the Moroccan medicines and health products agency, AMMPS, and creating regional pharmacovigilance centers within the country’s territorial health groupings, alongside a new advisory committee on drug safety.
A second draft decree introduces a risk-based annual surveillance program for medicines already on the market, empowering the agency to detect risks early, manage pharmaceutical alerts, and order corrective measures including product recalls or the suspension of marketing authorizations where non-conformities or health risks are identified.
A third draft decree overhauls the rules governing marketing authorizations, introducing accelerated procedures for medicines of major public health interest, a five-year data protection period for new chemical entities, a conditional authorization mechanism with a five-month review period, and an emergency-use authorization valid for one year during declared public health crises. The fourth text, a draft order, would adopt European Union good manufacturing practice guidelines as the applicable reference standard.
