📋 Tender Overview
The Pharmaceutical Inspection Cooperation Scheme (PIC/S) officially reported that the Ministry of Health, through the General Directorate of Medicines, Supplies and Drugs (Digemid), has been accepted in November to begin its pre-adhesion procedure to said organization, with the purpose of strengthening its regulatory capacities on Good Manufacturing Practices (GMP).
Digemid submitted the request to begin its pre-adhesion process to the PIC/S in July of this year, with the objective of strengthening the mechanisms and competencies necessary to apply an equivalent inspection system among the participating regulatory authorities. This request seeks to strengthen the authoritys GMP inspection and certification system, the quality system, regulatory requirements, the training of inspectors, among others.
The national pharmaceutical industry will also be strengthened by pre-accession, as it will have greater regulatory clarity and the possibility of participating in a broader dialogue with international regulators, which will result in a more dynamic process, since, by aligning with international standards, Perus competitiveness in the global market is improved. The PIC/S aims to harmonize pharmaceutical inspection procedures throughout the world, by developing common standards in the field of Good Manufacturing Practices (GMP) and providing training opportunities for inspectors. It also aims to facilitate cooperation and networking between competent authorities and regional and international organizations, thus increasing the regulatory confidence of member countries.
The PIC/S is made up of regulatory agencies from internationally renowned countries such as the United States, Canada, Denmark, France, Japan, among others. With this initiative, Digemid reaffirms its commitment to improving public health and the quality of pharmaceutical products, thereby ensuring their efficacy and safety, promoting international cooperation as a key tool to achieve more efficient and effective regulation in the service of the population.
