Marketing authorisation (MA) of a medicinal product is the process of reviewing and assessing the evidence to support that product, in relation to its marketing, finalized by granting of a licence to be sold.
This article briefly presents the requirements for the good manufacturing practice (GMP) certification for market authorization in Argentina, Brazil and Mexico.
When submitting an MA application for a medicinal product in several countries in Latin America, consideration must be given to the period of time in project timelines and other scenarios such as legalizing documents. There is also a wide range of GMP certification requirements and variation in the need to present certification for only one product or for intermediates of that, the product or active pharmaceutical ingredient (API).
With regards to biopharmaceuticals, a brief comparison of the GMP standards of various regulatory authorities (RAs) and international organizations (IOs) reveals that the standards are largely similar and appropriate in addressing the manufacturing challenges. The API in the medicinal product is responsible for providing a pharmacological or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of the disease, or alteration of the structure or function of the body .
Globally, there is a harmonization movement for the optimization of inspections by authorities for the certification of pharmaceutical manufacturing plants, represented by the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).
Argentina, Brazil and Mexico represent the countries with the largest sales volume in pharmaceutical industry in Latin America. The requirements to obtain GMP certification are briefly described below.
The regulatory body in charge of approving medicines in Argentina is the National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT). ANMAT is a member of PIC/S.
ANMAT requires the submission of GMP certification to drug products manufacturing plants issued by the authority itself, upon inspection, or by other authorities considered as a reference for sites located in their respective countries.
Authorities recognized by regulation are from the following countries: Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Spain, Sweden, Switzerland, The Netherlands, UK and US.
For manufacturing sites located in MERCOSUR, ANMAT recognizes the reports issued by the authorities of these countries, and it is necessary that ANMAT itself issues the certificate based on these reports.
ANVISA is the regulatory body in charge of approving medicines in Brazil is National Agency of Health Surveillance (Agência Nacional de Vigilância Sanitária, ANVISA). It is currently working to be a member of PIC/S.
For approval of drug products MA in Brazil, ANVISA requires the presentation of the GMP certificate issued by the agency itself for the drug product manufacturing site. For initial certification, ANVISA performs the inspection in the product manufacturing site. For re-certifications, ANVISA carries out a risk assessment to define the need for a new inspection.
The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). In January 2018, it became a member of PIC/S.
On 18 March 2021, three of COFEPRIS Guidelines were revoked for irregularities in their publication procedures, among them was the Guideline Establishing Criteria for GMP certification.
According to the previous version of the Guideline, from 16 March 2020 COFEPRIS required GMP certification from all sites involved in the drug product manufacturing chain, including the API manufacturers.
In the update to the Guideline issued in March 2020, the list of recognized authorities was reduced. The authorities now recognized are Therapeutic Goods Administration Australia, Health Canada, US Food and Drug Administration, Ministry of Health, Labour and Welfare Japan, Ministry of Food and Drug Safety Korea, Medicines and Healthcare products Regulatory Agency UK, Swissmedic and European Medicines Agency.
New certificates must have been presented in all new MA submissions and, in the case of products already approved, at the next renewal of the MA.
The matter must now go through the entire procedure under Mexico's Administrative Procedure Law before it can be regulated.
This article is the first of a series of four articles on the certification of GMP requirements in different countries in Latin America.
GMP certification requirements in Chile, Cuba and Venezuela
GMP certification requirements in Central American countries
GMP certification requirements in Andean Community countries
Cost savings after switching to generic tacrolimus
Biopharmaceuticals and biosimilars: manufacturing challenges
Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP
Follow-up study finds generic tacrolimus safe for kidney transplant patients
LATIN AMERICAN FORUM
The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Requisitos de certificación de BPF en Argentina, Brasil y México
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LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
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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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