Latin America Roundup: INVIMA touts reform effort

Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has published a draft of its plan outlining its new simplified processes for medical products, which is said will enable it to get products to market faster.

Under the leadership of Francisco Rossi, who assumed INVIMA’s directorship in March 2024, INVIMA has sought to shed its long-held reputation for interminable backlogs and a lack of transparency.

The draft plan, labeled a contingency plan by INVIMA, charts how processes are to be handled by the agency. Working groups within INVIMA, called cells, will assess a product’s risk level, categorize the type and complexity of the process, and establish the time frame for its resolution. “Virtual hearings” allow for license holders to communicate with agency personnel “when doubts arise or clarification is required,” INVIMA said. The new procedures apply to all processes that were pending as of 30 December 2024.

The plan was created with the input of Colombian pharmaceutical trade group Afidro, formerly one of the agency’s most frequent and ardent critics. In a video posted by INVIMA on X earlier this month, Afidro’s director, Ignacio Gaitán, praised the draft plan, adding that “the beneficiaries of an agile, modern INVIMA will be the patients.”

The plan comes amid other recent reforms by INVIMA intended to smooth relations with industry and assure steadier supplies of drugs and devices in Colombia.

INVIMA has been actively publicizing its industry-friendly mission through communications on X, its website, and other platforms. In an X post 10 March, the agency described its goal as assuring “simplification and automatization of processes that promote competition in the health sector and facilitate the work of small, medium and large companies, while retaining technical expertise and a focus on inspection, surveillance and control.”

In late February, the agency announced the launch of a new nomenclature and coding standards platform for medical devices and diagnostics. The platform, according to INVIMA, “allows license holders, manufacturers and importers to more effectively manage the usage of medical devices … and facilitate the identification of products in the production and distribution chains, as well as [aid] post-marketing surveillance of these products.”

INVIMA has also been conducting regular, in-person outreach to industry in different regions of Colombia, through seminars advising drug manufacturers and other members of the business community about INVIMA’s ongoing restructuring efforts. Some of these meetings have been led by Rossi.

INVIMA is recruiting at all levels, including seeking an experienced regulator to head its medical devices and diagnostics review committee, and appealing to university students through an internship program introducing them to the regulatory profession.

Chile, Argentina take enforcement actions against manufacturers

A Chilean court on 6 March upheld a decision by the country’s Institute of Public Health (ISP) to fine a generic drugs manufacturer for having distributed cracked tablets of lamotrigine, a medication to treat epilepsy and bipolar disorder, according to a 6 March report from the news site The Clinic. The product was of “insufficient hardness,” the ISP regulators determined, and fined the Argentina-based company, Laboratorios Andrómaco, the equivalent of $30,000 (USD). Andrómaco was among the producers implicated in a 2022 scandal in which the ISP found it to have distributed defective contraceptive pills.

In Argentina, regulators with the National Administration of Drugs, Food and Medical Devices (ANMAT) took aim at a Buenos Aires manufacturer of intravenous solutions and other products. On 24 February, ANMAT announced it had ordered all operations of Laboratorios Ramallo shut down, citing “significant deficiencies, classified as critical and serious” detected in its manufacturing processes after an inspection by the agency.

On 7 March, Pharmabiz.net reported that the company, since its inception in 2016, has been cited for repeat violations. In 2018 and again in 2019 Pharmabiz reported, Ramallo was forced to recall lots of dipyrone, a non-steroidal anti-inflammatory drug approved for use in Argentina. Recalls of other products occurred through 2022, the news site said, noting that these spanned “different government administrations,” a fact that highlights “the seriousness of the issue.” Even more serious, Pharmabiz wrote, “is that there are healthcare centers stocking up on [Ramallo’s] highly sensitive products,” such as IV solutions.

Statement (Spanish)

ANVISA updates manuals to align with ICH, new trials law

The Brazilian Health Regulatory Agency (ANVISA) has published new manuals that contain country-specific instructions for the Clinical Drug Development Dossier (DDCM) and Specific Clinical Trial Dossier (DEEC) processes, as well as adverse event and trial safety reporting for synthetic drugs, radiopharmaceuticals, biologicals and biosimilars tested in Brazil with the aim of marketing them there.

The manuals incorporate both the harmonized standards from the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH), and provisions of the sweeping Brazilian law from August 2024 that covers all clinical research in Brazil. The new law dictates time frames for the analysis of petitions and defines how analyses by approved foreign regulators may be applied, among other measures.

Statement (Portuguese)

Latin America Roundup: INVIMA touts reform effort

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