It is a state agency that is responsible for registering and controlling the quality of medicines, and marketing authorization in the country, acknowledged that its database of registered products is incomplete.
This is the National Administration of Medicines, Food and Medical Technology (ANMAT), a decentralized agency of the Ministry of Health, and the data contained in a report of Comptroller General's Office (SIGEN) approved this year, following an investigation initiated in 2009.
To fulfill its function, ANMAT is handled with the Register of Medical Specialties (REM), a list in which all products circulating in the domestic market appear. The SIGEN’s report says this roster “lacks information systems to record the entire approval certificates" issued for both drugs, as pharmaceutical items.
According to the ANMAT, certificates of enrollment on the REM amount to 55,118. The problem was that when the agency sought to itemize your data to a request from the SIGEN, submitted a list that "contained only 5,196 records". This release occurred on July 7th last year. Twenty days later, the Administration sent on the one hand, an Excel document with 25,200 certificates and, on the other, a file with 5,248 records digitized records "that does not cover all categories of drugs". In total, the receivership could access 35,644 registration certificates. In addition to recognizing the failure of its database, the area of Health added that "only since 1996 has more complete information." The date coincides with introduction of a system of electronic management of digitized records.
Within the ANMAT Registration Department, which has 70 numbered notebooks, where the certificates are based from 35,316 (Notebook 1 1 January 1978) to 55,118, taken as limit the closure of research works. For SIGEN, the information contained in those books "is not integral"; in fact, when the fieldwork began, “notebook number 29 was missing." Also, some approvals don’t have registered the file number of origin. Those documents, with which precisely approval certificates are processed, "are inaccessible in the short term," said the receivership, adding that the query is "difficult (because) are stored in the general archive of the Ministry of Health, which It takes several months to send them."
On the other hand, the Register of Medical Specialties works with a computer system that has two qualities highlighted by SIGEN: on the one hand, not automatically numbered certificates drug approval, making it difficult to control the process and, on the other "does not provide for automatic updating of the database", the same that also is incomplete. This means, according to the report, for details on approved remedies, "in many cases a cross manually necessary, a situation that increases the risk of errors, even more serious attentive to the health significance are made of the population." To illustrate the claim, SIGEN exemplifies with the excel it received with 25,200 records, "only 4,883 certificates contain the state of affairs" of the product in question; that is if they are enrolled, re-enrolled or expired.
The Trustee also argues that the data entry of the ANMAT’s database is task of various sectors; therefore, it is recommended that it "defines the responsibilities of the (offices) involved" because, in the absence of a structure formally approved indoors Administration, “responsibility for the management of information is diluted." In the same vein, it warns that the mission to keep updated REM "is not formally assigned to a specific area."
In addition to the "lack of updating the Register of Medical Specialties" the SIGEN detected a "considerable number of drugs whose certificates have expired."
From the normative, Law 16,463 establishes that authorizations to make and sell remedies, and their re-registrations, are valid for five years. And ANMAT Disposition 818/98 itself provides, as a necessary requirement to re-enroll in REM, within 180 days from the effective date of that decision.
Thus, the SIGEN asked the Administration for all the handled certificates since the 818 arrangement, and received files dated between January 1998 and July 2009. "This list does not contain enough to make the relevant controls information," says research and adds a fact: in the preamble to another provision of ANMAT, 2066/09, the "existence of a considerable number of certificates that are expired noted, without a corresponding re-registration applications in terms of legislation or failing, requests for cancellation of the same."
The SIGEN’s Report
Earlier this year SIGEN, the internal control agency under the National Executive Branch decided to withdraw their full reports from the www.sigen.gov.ar web page, citing the protection of personal data. Since then, the way to access these work is ordering them in writing to table entries agency in Corrientes 389, Capital Federal. That's what made a reporter for The Auditor.info, who finally received the results of the study on the management of the ANMAT to their personal address.