Market authorisation of a medicinal product represents a major effort for the pharmaceutical industry with a detailed plan with all the steps that are involved in the process.
This article briefly presents the requirements for the good manufacturing practice (GMP) certification for market authorization in some of the Andean Community countries: Bolivia, Colombia and Peru.
The Regulatory Affairs department in a company defines the requirements for GMP certification in addition to the development of preclinical, clinical and chemical manufacturing and control documentation. This is done according to the territories to which registration will be submitted.
With regards to biopharmaceutical products and the expiration of many of their patents, it is expected that there will now be a rise in the production of biosimilar products available. Due to the complex nature, production methods of biopharmaceuticals and biosimilars, as well as their sensitivity to physical and chemical conditions, these must be monitored to ensure the product’s quality, safety and efficacy. Therefore, it is vital to adopt appropriate GMP guidelines when manufacturing biopharmaceuticals to safeguard public health. It is important to ensure that the GMP guidelines adhered to in the countries that supply raw materials for production are in line with those producing the biosimilar .
In Latin America, there is a wide range of GMP certification related requirements and also variation in the need to present certification for only the drug product (finished product), or also for intermediates of that product and even for the active pharmaceutical ingredient (API).
The requirements to present GMP certificate in drug products marketing authorization submissions are briefly described below for the countries of the Andean region: Bolivia, Colombia and Peru.
None of these are members of the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).
The regulatory body in charge of approving medicines in Bolivia is the State Agency for Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tenologías en Salud, AGEMED).
AGEMED requires the presentation of GMP certificate for the drug product and accepts the document issued by the authority of the country where the manufacturing site is located.
The authority may request the inspection of the sites in question if they consider it is necessary; or may request additional information or the inspection report from the authority of the country of origin or from the applicant.
The regulatory body in charge of approving medicines in Colombia is the National Institute for Drug and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).
INVIMA requires GMP certificate from the drug product manufacturing site, as well as good laboratory practice (GLP) certification for the laboratory that performs quality control for product release, issued by INVIMA itself. For both, inspection by the authority is required. It also accepts the GMP certificate issued by the authorities recognized by them as reference.
These authorities are the ones from the following countries: Canada, Denmark, England, France, Germany, Japan, The Netherlands, Norway, Sweden, Switzerland and the US.
The regulatory body in charge of approving medicines in Peru is the Directorate General of Medicines, Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID) of the Ministry of Health (Ministerio de Salud, MINSA).
DIGEMID requires the GMP certificate from the drug product manufacturing plant issued by DIGEMID itself upon inspection, or by authorities recognized by them as reference.
DIGEMID recognizes GMP certificate issued by authorities considered by them as being of high surveillance, as defined by regulation, from the following countries: France, The Netherlands, the UK, the USA, Canada, Japan, Switzerland, Germany, Spain, Italy, Belgium, Sweden, Norway, Australia, Denmark, Portugal, Republic of Korea, Ireland, Hungary, and Austria.
This article is the second of a series of four articles on the certification of GMP requirements in different countries in Latin America.
GMP certification requirements in Argentina, Brazil and Mexico
Biopharmaceuticals and biosimilars: manufacturing challenges
Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP
LATIN AMERICAN FORUM
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LATIN AMERICAN FORUM
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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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