Morocco is preparing a sweeping regulatory refresh of its pharmaceutical sector — speeding up how new medicines reach patients, tightening how they are monitored once on the market, and formally handing the reins to the country’s new drug agency. Three draft decrees and one ministerial order have been posted for public consultation at the General Secretariat of the Government, according to Moroccan outlet Hespress.
Together, the texts modernize the regulatory framework governing medicines and health products, aligning it with Law 10.22, which established the Moroccan Agency for Medicines and Health Products (AMMPS). The reforms cover market authorization procedures, post-market surveillance, a national pharmacovigilance system, and good manufacturing and distribution practices — a package the government presents as part of the royal directive to achieve health and pharmaceutical sovereignty.
Fast-tracking new medicines to market
The first draft decree amends Decree 2.14.841 on marketing authorizations for medicines intended for human use. According to its explanatory memorandum, the text updates the framework in line with recent legislative, regulatory, scientific, and technical developments — and transfers powers previously held by the Ministry of Health and Social Protection to the new agency.
The proposed amendments introduce several notable mechanisms: specific conditions for authorizing certain categories of medicines; a fast-track procedure for reviewing applications for drugs already registered by recognized authorities abroad; the possibility for the agency to grant temporary or conditional authorizations for emergency use; clear rules on the validity period of authorizations and renewal procedures; and formal recognition of analyses conducted by accredited bodies or laboratories.
The stated aim is twofold — accelerate the entry of new medicines into the Moroccan market and reinforce transparency in the licensing process.
Watching the market after approval
The second draft decree (2.26.587) sets out how medicines will be monitored once they are on sale. The text organizes the planning, coordination, execution, and evaluation of post-market surveillance — with the aim of guaranteeing drug quality, safety, and compliance with regulations, and ultimately protecting public health.
Responsibility is entrusted to AMMPS, working through a risk-based approach. The decree defines the scope of quality controls: risk-based monitoring programs, enhanced surveillance for medicines flagged as sensitive, targeted and programmed sampling, analyses in qualified laboratories, evaluation of results, investigation of non-conformities, and tracking of corrective and preventive measures — all underpinned by a continuously updated database on drug quality.
Two further articles address advertising oversight. AMMPS will monitor pharmaceutical advertising for compliance, handle complaints and reports of non-compliant promotion, and coordinate alerts, recalls, and withdrawals — assessing their impact on public health and informing authorities, professionals, and the public of the measures taken.
A national safety net for adverse effects
The third draft decree (2.26.586) formally establishes the National Pharmacovigilance System, again coordinated by AMMPS in cooperation with the sectors and institutions involved.
Its objectives include organizing the reporting of adverse drug reactions, collecting and analyzing the data, detecting safety signals, adopting and evaluating risk-minimization measures, strengthening the exchange of information between stakeholders, and promoting the appropriate use of medicines.
The system’s components are equally detailed: the government health authority, AMMPS, regional pharmacovigilance centers, an advisory pharmacovigilance committee, plus health and pharmaceutical institutions, professional bodies, and patient associations. The advisory committee — whose members are appointed by the AMMPS director and include representatives from various sectors and independent experts — will evaluate drug-safety data and issue opinions on the measures required.
Manufacturing and distribution, European-style
Finally, a draft ministerial order from the Minister of Health and Social Protection sets out good manufacturing and distribution practices for medicines, in application of Article 68 of Decree 2.07.1064 on the practice of pharmacy and the opening of pharmaceutical establishments.
The text draws directly on European Union principles and guidelines for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicines intended for human use, adopting them as the technical reference for Moroccan industrial pharmaceutical establishments and wholesale distributors.
The government frames the move as part of a broader effort to reinforce quality, safety, and efficacy assurance across the entire pharmaceutical chain, align Morocco’s national framework with international standards, and — in doing so — boost the competitiveness of the domestic pharmaceutical sector and public confidence in the medicines circulating in the kingdom.
