The sanitary registration process for a new medicine, as well as the renewal and updating of products that are already in the market, are processes that should be agile; However, they take up to 17 months. The delays also affect the obtaining of the health license, electronic permits and certificates of good practices.
Guilds, associations and foundations of the health sector, backed by the schools of doctors and surgeons, and that of chemicals and pharmacists, have denounced that the times to carry out these procedures have been extended in the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA). The situation has caused an accumulation of 11 thousand 722 applications for products that are pending of the documents to be able to go on sale, only between October 2024 and March this year.
Óscar Paiz, president of the Guild Committee of Distributors of Pharmaceutical Products (Cogarfarma), points out that this situation affects the country’s economy, since competition is brake in the market.
A new product, having no sanitary record, cannot go to compete; Not doing so, the offer is limited and prices are not cheaper. While the delay in renovations subtracts the opportunity to sell the products and participate in bidding processes, for example.
Virginia González, of the Technical Commission of Regulatory Affairs of the College of Pharmaceuticals and Chemists of Guatemala (Cofaqui), points out that it is not only about arrears in process of sanitary records – new and renovations -, homologation, updates and certifications of medications, the devices and medical supplies, beauty products, cleaning, cleaning, and other related, and other related products are also affected. Operating licenses for laboratories and pharmacies; The processes for the import and export of products are also stagnant.
“There are companies that had products with campaigns that were going to be launched for Christmas, and this is the date that they have not been able to get them out of customs because they do not have the approved records,” says González, which translates into a loss for companies.
While some local pharmaceutical plants had to close production areas that were intended to manufacture export products, because they do not have the health records or the operation of operation. Here the OTC medications are mentioned – free sale – and this puts Guatemala at a competitive disadvantage within the region’s pharmaceutical market.
For example, to enter products to Mexico, the certification of the current sanitary registration is required and that the production plant has the updated good practices license, González points out.
📌 𝗖𝗢𝗠𝗨𝗡𝗜𝗖𝗔𝗗𝗢
The Technical Commission of Regulatory Affairs of the COFAQUI issues a statement together with unions, associations and foundations of the health sector, urging the MSPAS to expedite processes and resolutions of pharmaceutical products.#I am chemical pic.twitter.com/vxdenhg6pa
– Cofaqui (@Cofaquiguate) April 23, 2025
“There are products registered in Guatemala and that we already export to Central America, but if the sanitary registry is expired here and they do not renew it soon, we lose the opportunity to sell them in other countries. This subtracts us competitiveness, with which we lose markets and jobs. The Guatemalan pharmaceutical industry generates around eight thousand direct jobs and 50 thousand indirect,” says Deborah de Motta, director of Motta, director of Motta. Pharmaceutical Core of the Association of Exporters of Guatemala (AGEXPORT).
The pharmaceutical industry in the country produces more than 2,000 products – from OTC to specialized used in ophthalmology, cardiology and gastroenterology -, which are distributed at the local level and abroad. The delay in registration procedures worries the sector, since it can cause shortage in the medium term.
According to the Cofaqui, there are professionals who are dedicated exclusively to the process of health records and the arrears in the DRCPFA have affected their income. There are also companies that have not been able to participate in bidding competitions for not having the renewal or a certificate of good practices, and others that have slow to open pharmacies or sales of medications due to lack of permission, while the rental payment of the premises continues to run.