The General Directorate for Medicines, Supplies, and Drugs (Dirección General de Medicamentos, Insumos y Drogas or DIGEMID) of the Ministry of Health signed an agreement on Friday, November 10th, expressing the institution’s commitment to become an International Reference Authority for Medicines, recognized by the Pan American Health Organization (PAHO) and the World Health Organization (WHO).
Level IV National Regulatory Authority for medicines and biologicals is the highest possible ranking under those international agencies. This category means that the entity is competent and efficient in the performance of the health regulation functions recommended by PAHO and WHO to guarantee the efficacy, safety, and quality of medicines. By signing this agreement, DIGEMID reaffirms its commitment to ensure access to safe, effective, and quality medicines, supplies, and technology.
The Executive Director of DIGEMID, Henry Rebaza, said that the efforts made by his office have been undertaken within the modernization process at the Ministry of Health. He stated that the Level IV designation would allow DIGEMID to sign cooperation agreements with other countries that also have Level IV medicine regulators.
“This process has progressed thanks to the teamwork achieved by DIGEMID employees and managers over many years. In acknowledgment of this, the objective now is to obtain that designation, which will help consolidate our contributions to the health of the Peruvian people,” he said.
Evaluation criteria
The DIGEMID evaluation will be based on WHO’s Best Practices for manufacturing, laboratories, distribution, and clinical research.
To make the determination, the indicators included in the data collection tool will be verified. This instrument entails:
- Regulation and product registry;
- Inspections and audits;
- Issuance of licenses for manufacturers;
- Clinical trials;
- Market oversight;
- Pharmaceutical product oversight; and
- Quality control laboratories.
Pharmaceutical market oversight
The DIGEMID director explained that the most important aspects of this process include the configuration of modern regulations and the oversight of the pharmaceutical market, as well as the promotion of research.
“I am sure that we will soon receive this designation that will contribute to the improvement of people’s access to safe medicines; the professionals in charge of this process are highly qualified and the workers will be able to help other regulatory authorities receive the same designation,” he said.