The Ministry of Pharmaceutical Industry works to develop the pharmaceutical industry sector as a guarantor of health sovereignty and a wealth generator, by encouraging local production of medicines and ensuring details of their quality, effectiveness and security through the National Agency for Pharmaceutical Materials.
The Minister of Pharmaceutical Industry explained in response to a written question submitted by Representative Rabah Jeddou in the National People’s Assembly regarding the details of ensuring the safety of vaccines and new medicines, especially in the exceptional circumstances of emerging epidemics, that the legislative and regulatory texts set the parameters of pharmaceutical policy in this field and regulate the work of the National Agency for Pharmaceutical Materials, especially the provisions of Health Law No. 18-11 of July 2, 2018, amended and supplemented, as well as the provisions of Executive Decree No. 19-190 of July 3. July 2019, which defines the tasks, organization and amended and supplemented functioning of the National Agency for Pharmaceuticals.
The Minister pointed out that the agency is responsible for registering pharmaceutical substances, granting the registration decision, renewing it, and, when necessary, suspending, withdrawing, waiving and transferring it after the opinion of the Pharmaceutical Substances Registration Committee. It also monitors the quality and conducts expertise on pharmaceutical substances and certifies the quality control laboratory for pharmaceutical institutions to produce approved pharmaceutical substances intended for human medicine.
He added that the agency carries out audit and field inspection tasks carried out by its inspectors, which include, in particular, monitoring the application of the rules and details of good pharmaceutical practices in accordance with applicable legislation and regulation, and notifying the competent authorities to take the necessary measures aimed at preserving public health in the event of the presence of a pharmaceutical substance that constitutes or may constitute a danger to human health.
Regarding the drug registration file, the Minister explained that it includes, in accordance with the provisions of the Ministerial Resolution dated May 10, 2021, information related to the qualitative and quantitative composition of all components of the drug, therapeutic data, contraindications and undesirable effects of the drug, the dosage and pharmaceutical form, the manner and method of taking the drug, the conditions and duration of preservation, a description of the manufacturing method, a description of the control methods used by the manufacturer, the results of pharmaceutical experiments, non-clinical and clinical experiments, a license to place on the market in the country of origin and a certificate. The pharmaceutical product and the free sale certificate, or any other document proving the registration and marketing of the drug in the country of origin.
He pointed out that the effectiveness and safety of the vaccine is guaranteed based on the studies and results of experiments conducted on these vaccines, using what is called the principle of regulatory trust and mutual recognition of decisions, reports, certificates, regulatory opinions, or any other information issued by the national, regional, or international regulatory authorities competent in the field of pharmacy and health, which has been framed in a regulatory text recently.
The Minister stressed that the local pharmaceutical system relies, in accordance with international standards, on a national system of vigilance regarding medicines and medical equipment, after launching the products on the national market, in which the Ministries of Health and the Pharmaceutical Industry, as well as the National Agency for Pharmaceutical Materials and the National Center for Vigilance, regarding medicines and medical equipment, share roles according to the powers of each sector and each institution.
The work of this system and the role of each institution in it were recently framed under the provisions of the Joint Ministerial Decision dated September 10, 2025, which includes the organization and functioning of the National Vigilance System for Medicines and Medical Equipment. The Minister indicated that notifications related to the quality and effectiveness of pharmaceutical materials, as well as notifications related to the performance of medical supplies, are processed through this system through studies, evaluations, conducting expertise, or monitoring quality, or evaluating the balance between benefits and risks after the occurrence of side effects from the use of medicines, vaccines, and medical supplies.
Pursuant to the joint ministerial decision, a consultative committee was established that includes representatives of relevant sectors and institutions charged with enhancing coordination among actors in this system, through studies that require joint analyzes and result in proposing measures aimed at preserving public health.
The Minister revealed that his sector is working to develop the digitalization aspect related to combating all counterfeit medicines that may be included in the patient care chain illegally, by introducing a serial tracking system through codes placed at the level of drug units, in order to track them from their manufacture or import until their distribution and arrival to patients at the level of pharmacies or hospitals.
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