Latin America Roundup: INVIMA chief says restructuring will promote faster reviews, greater surveillance

Francisco Rossi, the director of Colombia’s National Institute for Food and Drug Surveillance (INVIMA) spoke to participants at a healthcare industry conference about the transformation of the agency after its recent restructuring.

At the conference, which took place in Bogotá on 5-6 September, Rossi said that some 80 percent of INVIMA’s resources have traditionally been taken up by processes such as marketing approvals and renewals, leaving the agency ill equipped to carry out its pharmacovigilance activities and inspections.

The idea behind the ongoing restructuring process, Rossi said, is to speed processes dramatically and free more resources for surveillance. Rossi cited Mexico and El Salvador as examples of countries whose national regulatory agencies have taken a similar approach. “We want to be seen not as an institution of procedures, but as an entity that inspects, monitors and controls,” Rossi said.

In his talk, summarized by ConsultorSalud, a healthcare news site and the conference’s sponsor, Rossi listed other changes underway at INVIMA. New databases to be rolled out late this year will better predict approval times and simplify procedures, he said, adding that the agency’s notoriously long wait times created a fertile environment for corruption.

He also promised regulatory reforms that will promote competition and facilitate product development in Colombia. INVIMA has signed agreements with the National Business Association of Colombia (ANDI) to create draft reforms.

Rossi, a frequent critic of the practices of global pharmaceutical manufacturers in the developing world, stressed the importance of regulation that supports the interests of small and medium-sized companies. Colombia’s current regulatory scheme, he noted, applies the same user fees to large multinational and local firms alike, putting the latter at a competitive disadvantage. “We need a tiered [system],” he said, adding that the agency was exploring new ways to address this problem.

INVIMA’s funding – which since the agency’s inception in 2012 has come solely from user fees – is also being reconsidered, Rossi said, and INVIMA is in talks with Colombia’s finance ministry to look at other funding sources. The problem with the current model is that it can generate conflicts of interest with regulated entities, Rossi argued, and limits the agency’s capacities.

Finally, Rossi pointed to INVIMA’s new operations manual, higher salaries, and expansion of hiring as among its achievements in the first phase of its ongoing reform process.

ConsultorSalud (Spanish)

Panama meets with UN bodies on pharma hub ambitions

Panama’s commerce minister met with representatives of two United Nations agencies as part of an ongoing effort to bolster the country’s engagement with the pharmaceutical sector, the Panamanian government said in a 22 August news release.

Officials with the United Nations Industrial Development Organization (UNIDO) and the United Nations Development Program (UNDP) participated in the meeting.

Panama’s healthcare product manufacturing sector is small, counting six national drug makers, one long-running plant owned by GlaxoSmithKline, and no medical device makers. The country has in recent years sought the UN’s help to identify more opportunities in the pharmaceutical industry and to better position itself as a distribution hub for medical products in Central America and the Caribbean.

In 2018, UNIDO and the Panamanian government joined forces on a multi-year feasibility study to determine whether the Central American country, a shipping giant which already counts an advanced logistics and cold chain infrastructure, could develop its drug distribution activities and also “integrate backward into manufacture of finished pharmaceutical products, as well as possibly into research and development of new, innovative medicines.”

In April 2024, the Panamanian government published a follow-up report concluding that value-added distribution services – the repackaging and labeling of medicines from bulk products followed by their warehousing, distribution and export -- were the most promising growth area for Panama, followed by clinical trials and manufacturing.

A focus on distribution, rather than manufacturing, would distinguish Panama’s ambitions from those of neighboring Costa Rica, which now boasts a strong and growing medical devices manufacturing sector second only to Mexico’s in Latin America.

The April report also noted that Panama has certain regulatory advantages that could help it attract clinical trials, including faster times to approvals than are standard in the region. The report recommended that any “existing regulatory bottlenecks” be identified and removed as part of Panama’s overall strategy.

Statement (Spanish)

New top regulator in Costa Rica

On 26 August, Bernny Villareal Cortés, a physician, was named Costa Rica’s new General Director of Health, replacing Ariana Angulo Alvarado, who briefly served as interim head of the agency.

The Ministry of Health is responsible for regulation of medical products and devices in Costa Rica. In the past two years it has experienced multiple shakeups of top staff.

Villareal Cortés previously held several key positions with the Costa Rican Social Security Fund, which administers much of the country’s public health system.

Statement (Spanish)

Argentina’s ANMAT seeks help strengthening surveillance communications

Regulators with Argentina’s National Administration of Food, Drugs and Medical Devices (ANMAT) said on 5 September that they had met with officials from the Uppsala Monitoring Centre (UMC), a global pharmacovigilance group, and the Pan-American Health Organization (PAHO). The purpose of the two-day meeting was to explore ways to communicate adverse events reports, particularly those related to vaccines, from ANMAT to the UMC’s global database. This process also involves aligning reporting language with international standards set by the World Health Organization and the International Council for Harmonisation (ICH).

ANMAT has made recent investments in pharmacovigilance technology. In 2023, the agency introduced a new adverse effect reporting platform for patients and healthcare providers. This year, the agency rolled out a separate platform for use by industry.

Statement (Spanish)

Mpox vaccine fast-tracked in Mexico

In an effort to get ahead of a potential mpox outbreak caused by recently circulating strains, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) said on 3 September that it would issue a decision about a mpox vaccine product within 10 days.

The product, called JYNNEOS and manufactured by Bavarian Nordic, was approved by the US Food and Drug Administration in August 2022. The company is seeking a full marketing authorization, rather than an emergency-use approval, from COFEPRIS. If approved, this would be the first mpox vaccine available in Mexico.

Statement (Spanish)

Brazil to launch new device reporting platform

The Brazilian Health Regulatory Agency (ANVISA) announced 28 August that it would soon launch a new system for reporting adverse events and technical complaints related to medical devices.

This platform, dubbed e-Notivisa, will offer the public “an even more efficient tool to report incidents involving in vitro diagnostic products, medical-dental materials and equipment, or [other devices]. The new module simplifies the notification process, making it more intuitive and accessible, in addition to enabling companies to respond directly to citizens,” the agency said.

Statement (Portuguese)

Latin America Roundup: INVIMA chief says restructuring will promote faster reviews, greater surveillance

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