Before submitting documentation for the marketing authorization of a medicinal product in several countries in Latin America, there are several requirements that have to be taken into consideration
In particular, biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn, this leads to complex manufacturing processes. It has revealed that we are well on the way to global harmonization of GMP standards that will help bring these products to more people across the globe [1].
This article briefly presents the requirements for the good manufacturing practice (GMP) certification for market authorization in the RTCA signatory countries: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama.
The Central American Technical Regulation (RTCA) establishes the conditions and requirements under which the sanitary registration of natural medicinal products for human use for commercialization. This regulation applies to natural medicinal products for human use manufactured or imported by natural persons or companies for commercialization in the States Parties of the region Central American.
The following is a brief description of the requirements for the submission of GMP certificates in marketing authorization applications for medicinal products from RTCA signatory countries.
The authorities of each of these countries follow the requirements set by the harmonized RTCA regulation for drug product market authorization applications. Each of them requires the presentation of the GMP certificate for the drug product and accepts the document issued by the authority of the country where the manufacturing site is located.
It is provided by the RTCA that the local authorities may inspect the plants in question if they deem necessary; or recognize the certification of authorities considered to be of high surveillance by the World Health Organization (WHO).
This article is the third of a series of four articles on the certification of GMP requirements in different countries in Latin America.
Related articles
GMP certification requirements in Chile, Cuba and Venezuela
GMP certification requirements in Andean Community countries
GMP certification requirements in Argentina, Brazil and Mexico
Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP
Reference
1. Sia CH, Sia MK, Chan LW. Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):52-63. doi:10.5639/gabij.2020.0902.010
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