Drugs- New Guidelines for Human Medicines

AMMPS Publishes New Guidelines for Human Medicines
(11 December 2025)

The Moroccan Agency for Medicines and Health Products (AMMPS) has published three new regulatory guidelines aimed at improving the efficiency, transparency, and scientific rigor of the evaluation process for human medicinal products.
This initiative aligns Morocco’s regulatory framework with international standards, including those of the International Council for Harmonisation (ICH) and the World Health Organization (WHO).

The New Guidelines Published :

• Common Technical Document – Quality
Defines requirements for the preparation and evaluation of the quality section of Marketing Authorization Applications, enhancing the consistency and quality of submitted data.

• Evaluation of Biological Products
Establishes specific expectations for biological medicines, improving dossier structure and aligning evaluation practices with international standards.

• Good Review Practices for Human Medicines
Harmonizes the regulatory and scientific review of marketing authorizations, variations, and renewals.
Strengthens evaluator training, formalizes expert involvement, ensures independence and confidentiality, and reinforces the traceability and consistency of regulatory decisions.

A Key step for National Regulatory Modernization:

The publication of these three guidelines marks a significant milestone in the modernization of Morocco’s pharmaceutical regulatory system.

It reflects AMMPS’s commitment to promoting a more robust, transparent, and internationally aligned evaluation process in the interest of public health.

These new guidelines introduce higher expectations for the preparation, submission, and scientific evaluation of marketing authorization dossiers in Morocco.
Our team helps pharmaceutical companies, importers, and regulatory affairs departments ensure full compliance by providing:

Guidance on CTD structure and dossier preparation
Support for biologics regulatory strategy and documentation
Review and optimization of MA, variation, and renewal submissions
Alignment of internal processes with Good Review Practices
Training and regulatory intelligence tailored to AMMPS requirements

If your organization needs assistance adapting to these new guidelines or strengthening its regulatory submissions in Morocco, we are ready to support you with tailored expertise.

AMMPS Publishes New Guidelines for Human Medicines
(11 December 2025)

The publication of these three guidelines marks a significant milestone in the modernization of Morocco’s pharmaceutical regulatory system.

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AMMPS Publishes New Guidelines for Human Medicines (11 December 2025)

1 réflexion sur “Drugs- New Guidelines for Human Medicines”

Répondre à Benouna Imane Annuler la réponse

AMMPS Publishes New Guidelines for Human Medicines
(11 December 2025)