Law 27.26: Morocco’s Bid to Become a Regional Pharmaceutical Hub
Analysis of Law 27.26 and Morocco’s ML3 ambition, covering stronger AMMPS powers, export AMMs, conditional authorizations, pharmacovigilance, inspections and regional pharmaceutical-hub positioning.
The Minister of Health and Social Protection, Amine Tehraoui, presented Bill 27.26 on 14 May 2026 before the Social Sectors Committee of the House of Representatives. The bill amends and supplements Law 17.04 establishing the medicines and pharmacy code. The text had been adopted by the Government Council on 23 April 2026. Its central objective is to equip the Moroccan Agency for Medicines and Health Products (AMMPS) with the powers needed to reach WHO (World Health Organization) regulatory maturity level ML3 (Maturity Level 3).
Three questions structure the analysis: what does ML3 concretely bring to Morocco’s regional positioning? How should medicine sovereignty, industrial attractiveness and access to innovative treatments be articulated? Does AMMPS have the operational resources needed to absorb its new missions?
1. What WHO ML3 Measures
WHO classifies national pharmaceutical regulatory authorities into four maturity levels, evaluated through the Global Benchmarking Tool (GBT) across more than 250 indicators. ML3 designates a stable, integrated and well-functioning regulatory system; ML4, the highest level, designates an advanced system in continuous improvement.
To date, eight African countries have reached ML3: Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe. Morocco is not yet among them. Accreditation produces three documented operational effects: reducing substandard and falsified medicines, encouraging local production and increasing rapid-approval capacity in health emergencies. Authorities classified ML3 and ML4 can also be recognized as WHO-Listed Authorities, a status that conditions the international recognition of regulatory decisions.
2. What Law 27.26 Changes
The bill is structured around four blocks of regulatory innovation.
Expansion of AMMPS powers. The text strengthens AMMPS powers in inspection, pharmacovigilance and market surveillance. AMMPS becomes the single regulatory pivot, replacing the previous fragmented system.
New authorization regimes. The law introduces a marketing authorization (AMM) intended exclusively for export for nationally manufactured products, as well as a conditional AMM granted for a defined period even in the absence of complete data on the medicine’s efficacy and safety. This conditional regime is framed by three cumulative criteria: benefit greater than risk, unmet medical need, and serious or life-threatening disease. An emergency-use authorization is also provided for health-crisis situations or a declared public-health emergency.
Strengthened post-marketing control. Article 130 of the bill subjects pharmacies, clinics, pharmaceutical establishments and medicine depots to AMMPS inspections. These controls, carried out by sworn pharmacist inspectors appointed by the AMMPS director, cover pharmacovigilance, manufacturing, distribution and stock-management rules. The text also introduces specific provisions for biological medicines, biosimilars and plant-based products.
Tougher sanctions. The bill provides for tougher administrative and criminal penalties in cases of non-compliance with good manufacturing and distribution practice rules. Article 156 provides for fines for any breach of manufacturing or pharmacovigilance rules.
3. The Industrial Context and Dependence on Imports
The scope of Law 27.26 must be assessed in light of the structure of Morocco’s pharmaceutical industry. Morocco’s pharmaceutical industry covers 80% of the country’s medicine needs by volume and makes Morocco the second-largest pharmaceutical producer in Africa, after South Africa, and the fifth in the MENA region. The sector includes 50 industrial pharmaceutical establishments (EPI).
Coverage by volume, however, does not reflect coverage by value. In value terms, local production covers only 57% to 60% of needs. The recent trajectory of imports confirms this: medicine imports rose from MAD 9.5 billion over the first nine months of 2025 to MAD 14.9 billion between October 2025 and February 2026. In March 2024, about 1,200 medicines, or 19.3% of the 6,211 available references, were out of stock in Moroccan pharmacies.
Reaching ML3 has a documented effect on both parameters: it encourages local production and reduces dependence on imported medicines by making Moroccan authorizations recognizable by other jurisdictions and facilitating export. The AMM regime intended exclusively for export, introduced by Law 27.26, formalizes this industrial lever.
4. Access to Innovative Treatments: What the New AMMs Make Possible
Conditional authorization and emergency-use authorization respond to two distinct situations.
Conditional authorization targets medicines for serious diseases where complete efficacy data are not yet available. The expected benefit must outweigh the risks linked to the absence of additional data. The pharmaceutical establishment undertakes to provide the missing data within a deadline set by AMMPS. This mechanism aligns Morocco with the practices of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which have equivalent regimes, namely conditional marketing authorisation and accelerated approval.
Emergency-use authorization targets health crises, serious epidemics or declared public-health emergencies. These authorizations can be converted into standard AMMs if the medicine subsequently meets the required criteria. The mechanism follows on from the decree of 4 May 2026, which introduced the possibility of an accelerated procedure for biomedical research in public-health emergency contexts.
These two regimes shorten the time between the international availability of an innovative treatment and effective access for Moroccan patients. They do, however, transfer part of the regulatory risk from initial authorization to post-marketing control, which explains the parallel strengthening of AMMPS inspection powers.
5. The Question of AMMPS Operational Capacity
Expanding AMMPS missions requires a level of operational capacity compatible with ML3 requirements. The GBT evaluates the regulatory authority across about 268 sub-indicators divided into nine cross-cutting themes, including clinical-trial authorization, AMM, pharmacovigilance, market surveillance, inspection and quality management. Each theme requires a documented system, qualified human resources and auditable processes.
Available public information indicates that AMMPS launched several corrective measures in 2025, including improved monitoring of national stocks, strict application of mandatory safety stock for vital medicines, and accelerated review of registration files by prioritizing essential medicines. These measures enabled a decrease in exceptional import authorizations in 2025, a partial indicator of rising capacity.
Three factors condition the trajectory toward ML3. The first concerns staffing and training of sworn pharmacist inspectors, whose number must be compatible with the expanded inspection perimeter provided for in Article 130. The second concerns information systems: pharmacovigilance and market surveillance require platforms interoperable with hospital and industrial establishments. The third concerns AMM processes: conditional and emergency regimes require scientific evaluation capacity backed by an independent expert committee. The law’s implementation timeline provides six months for publication of implementing decrees, a period during which these capacities will need to be consolidated.
6. Regional Positioning: What ML3 Produces
For African countries, ML3 accreditation produces observable effects across three dimensions.
On industrial attractiveness. International sponsors and pharmaceutical manufacturers choose locations based on the regulatory maturity of the jurisdictions concerned. An ML3 authority reduces the cost and timeline of double-evaluation procedures and smooths technology transfers. For countries such as Kenya, which are targeting ML3, the explicit objective is to attract investment and position themselves as leaders in the regional pharmaceutical market.
On access to medicines. ML3 opens eligibility for WHO-Listed Authority status, allowing other jurisdictions to rely on Moroccan assessments for their own decisions. This mutual recognition is one of the most effective levers for accelerating the availability of innovative treatments at continental scale.
On health sovereignty. The ML3 trajectory is part of the continental dynamic driven in particular by Africa CDC (Africa Centres for Disease Control and Prevention) and the African Continental Free Trade Area (AfCFTA), which aim to increase Africa’s share of pharmaceutical production. Today, the continent produces only about 3% of the medicines it consumes. Strengthening national regulatory authorities is one of the documented prerequisites for any significant increase in this share.
7. Timeline and Points to Watch
Bill 27.26 must now complete parliamentary review before adoption. The government hopes for adoption before the end of the current legislative session. Implementing decrees will be published within six months after promulgation. AMMPS, professional orders and manufacturers will need to adapt their procedures and control tools within the same window.
Several intermediate indicators will make it possible to track the actual trajectory toward ML3: number of pharmacist inspectors deployed, median AMM review timeline, number of conditional AMMs granted, effective deployment of the pharmacovigilance platform, and WHO GBT evaluation timetable. None of these indicators is yet public at the scale of Law 27.26.
Conclusion
Law 27.26 gives Morocco a regulatory framework compatible with WHO ML3 requirements. Its scope can be measured at three levels. At industrial level, it formalizes an AMM regime dedicated to export and strengthens the regulatory attributes needed to attract pharmaceutical investment. At care-access level, it introduces conditional and emergency authorization mechanisms that shorten the time needed to make innovative treatments available. At regional level, it positions Morocco on the trajectory of the eight African countries already classified ML3, with the potential for mutual recognition of regulatory decisions across the continent.
Turning the normative framework into effective regulatory capacity nevertheless depends on operational parameters that cannot be resolved by publishing a text alone: inspection staffing, pharmacovigilance information systems and expert committees for scientific evaluation of files. The six months planned for publication of implementing decrees constitute the first observation window. The path toward ML3 will be visible in the intermediate indicators that AMMPS chooses, or does not choose, to publish in the coming months.