Salud begins the transformation into the regulatory entity of the country’s pharmaceutical industry

2023-06-17 02:13:11

With the objective of offering Guatemalans quality, safe and effective pharmaceutical products, the Ministry of Public Health and Social Assistance -MSPAS- presented the report Technical Cooperation Mission “Transformation of the National Regulatory Authority for Pharmaceutical and Related Products”.

The event was chaired by Dr. Francisco Coma, Minister of Health; Leslie Samayoa, Vice Minister of Health Regulation, Surveillance and Control; Franco Martínez, Undersecretary of SEGEPLAN, and Gerardo Alfaro, of the Pan American Health Organization.

As a result of the work carried out, Vice Minister Leslie Samayoa delivered four documents and protocols that seek quality in the regulation of pharmaceutical products, these being:

• Competency profiles manual
Its objective is to establish what are the requirements when carrying out an optimal recruitment of personnel.

• Quality manual
Describes the structure, processes, activities, managers, control and continuous improvement of the Integrated Management System (GIS).

• Document management manual
It contains in an orderly and systematic way the information and instructions to carry out with greater efficiency and effectiveness the work assigned to the personnel.

• Procedure for drafting and reviewing regulations
Set the appropriate requirements and formulate decisions that are clear, transparent and consistent.

“These documents are the fundamental pillar for the operation of a reference regulatory entity, and, as of today, we assume the commitment of their correct implementation,” said Vice Minister Samayoa.

Likewise, he highlighted that Guatemala is one of the countries in the region with the most important pharmaceutical industry, finding itself in constant growth and aligned with the global technological dynamism, for which it is necessary to promote the progress of the regulatory authority, which ensures mechanisms that comply with international standards, promoting agile processes and guaranteeing access to quality health products.

For his part, Dr. Francisco Coma, head of the Health portfolio, said: “Having these four manuals, which seem to be few, but are essential for the future of the ministry. For me it has been fundamental, together with my team and the support of all of you, to leave products that will be reflected in the efficiency, transformation, transparency and, above all, the growth of an industry that is the engine for Guatemala.

The activity was also attended by officials from the Ministry of Economy, representatives of the Guatemalan Social Security Institute -IGSS-, delegates from AGEXPORT, Chamber of Industry, Chamber of Commerce, ASOFARGUA and FEDEFARMA.

The Guatemalan government, under the leadership of President Alejandro Giammattei and the Ministry of Public Health and Social Assistance, complies with providing key products in the strengthening and governance of the drug regulatory authority.