Latin America Roundup: Agencies, PAHO hold meetings on convergence
Roundups | 02 July 2024 |
Last month Latin America’s national regulatory authorities of reference met in Washington to discuss progress on a two-year-old plan to strengthen regulatory capacities across the Americas and “address gaps” in reaching that goal, according to agency statements. The meeting was organized by the Pan American Health Organization.
During the meeting, held 12 and 13 June, officials with the agencies of Chile, Mexico, Argentina, Colombia, Cuba, and Brazil discussed pathways to becoming WHO-Listed Authorities (WLAs). This designation is granted to agencies “operating at an advanced level of performance,” according to the World Health Organization. WLA’s are also an instrument of harmonization, as they are intended to help foster regulatory reliance.
In a news release issued after the meeting, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS), said it had presented on its regulatory certainty agenda for pharmaceuticals and biosimilar medications. COFEPRIS also touted the advances of its digital platform, which, according to the agency, has streamlined procedures while reducing opportunities for corruption. In its own statement about the meeting, Argentina’s National Administration of Drugs, Foods, and Medical Devices said its representatives had presented on becoming a full member of the International Council for Harmonisation last month.
On 21-23 August, Mexico will host the Pan American Network for the Harmonization of Medical Regulation (PARF), a joint initiative of the national regulatory authorities of reference and PAHO. The conference, COFEPRIS said, will “address achievements and challenges in regulatory convergence and harmonization in the Americas” and explore regulatory mechanisms “to integrate supply chains with improved standards of safety, quality and efficacy, as a public health priority.”
COFEPRIS has been among the leaders of Latin American agencies in advancing harmonization efforts, particularly those that could help Mexico get more lower-cost drugs and biosimilar medications into its public health system.
On June 20 and 21, COFEPRIS said in a separate statement, its officials met with EU representatives, including the ambassadors of Belgium and Denmark, to promote closer collaboration with the EU biopharmaceutical sector, “With the aim to exchange best practices that guarantee the resilience of health systems, the construction of international alliances for the supply of vaccines, and equal availability of medicines, thereby advancing health self-sufficiency in Latin America.”
Statement (Spanish)
Colombia convenes experts to tackle medicines supply issues
In a gesture that marks a change of tone for an agency until recently on the defensive about its long backlog of procedures and its role in exacerbating medicines shortages, Colombia’s National Food and Drug Surveillance Institute (INVIMA) convened a meeting of industry representatives, heads of healthcare systems, insurers, and officials with other agencies to brainstorm solutions.
The meeting, announced 13 June, was held to “identify and address, jointly, those situations that affect the supply of medicines in the country; promote collaboration between the different actors involved in the supply chain; and guarantee timely and adequate access to medicines by the Colombian population,” INVIMA said.
Representatives of the invited entities offered perspectives on the causes of shortages and supply-chain delays and how to best to avert them. INVIMA, for its part, pledged better public reporting about medicines at risk and updated on its progress.
INVIMA’s recently named director of medicines, Sandra María Montoya Escobar, said that the agency had now cleared 60% of its pending procedures that had been tied up in delays in recent months, with special attention paid to medicines deemed at risk of shortage, Montoya Escobar said. The number of medicines flagged by the agency as unavailable has been reduced to 10, from 30 in May.
In April 2023, Colombia’s Attorney General’s opened an investigation into INVIMA’s role in medicines shortages. In February of this year, Francisco Rossi was named agency director after a year and a half with only acting directors. Rossi quickly initiated a series of actions to reduce regulatory backlogs and medicines shortages.
In an interview with Colombia’s Caracol Radio on 21 June, Rossi said he hoped that the agency sought to assure that future product registrations take no longer than 6 months in Colombia.
Statement (Spanish)
El Salvador’s new agency slashes proposed functions
Approved by an act of the Salvadoran legislature in November 2023, El Salvador’s new Superintendency of Health Regulation (SRS) was originally scheduled to have four management divisions: pharmaceutical products, food and beverages, products for agricultural use, and surveillance. On 19 June these were reduced to two by the same legislature: registrations (or authorizations) and surveillance. Noé Geovanni García, head of the country’s national Directorate of Medicines (DNM) one of the agencies in the process of being dissolved to create the new entity, explained to legislators that the changes were to make the new agency – expected open in August – more efficient and responsive.
ElSalvador.com
Latin America urged to follow Spain’s example on clinical trials
Brazil, Argentina, Mexico and Chile lead Latin America in the number of clinical trials underway, but they all lag European countries with similar-size populations, according to presenters at a 13 June seminar in Santiago, Chile. The proposed solution: follow the Spanish example.
At the seminar, sponsored by a Chilean pharmaceutical trade group and the United Nations’ Economic Commission for Latin America and the Caribbean (CEPAL), Amelia Martín Uranga, director of clinical investigations for the Spanish trade group Farmaindustria, presented on Spain’s transition to a trials leader over the past two decades, according to a statement by the trade group.
Between 2004 and 2006, Spain began changing rules that had made it less competitive for clinical research and began investing more heavily in trial infrastructure through a public-private research and development collaboration called BEST, Uranga reported. Last year 2023 Spain saw more than 4,600 trials, up from 117 in 2004, according to the BEST website.
The Spanish example may not be an easy one for Latin American countries to follow, given the relative strength of Spain’s national health system and the advantage of a harmonized platform for trial sponsors and regulators across the European Union.
CEPAL, in its statement, estimated that Latin American countries had the capacity to grow their current number of trials by fourfold. However, the agency added, “for this to become a reality, it is essential to follow the example of leading countries and join forces to build a community that promotes the … reduction of barriers to its implementation.”
Statement (Spanish)
During the meeting, held 12 and 13 June, officials with the agencies of Chile, Mexico, Argentina, Colombia, Cuba, and Brazil discussed pathways to becoming WHO-Listed Authorities (WLAs). This designation is granted to agencies “operating at an advanced level of performance,” according to the World Health Organization. WLA’s are also an instrument of harmonization, as they are intended to help foster regulatory reliance.
In a news release issued after the meeting, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS), said it had presented on its regulatory certainty agenda for pharmaceuticals and biosimilar medications. COFEPRIS also touted the advances of its digital platform, which, according to the agency, has streamlined procedures while reducing opportunities for corruption. In its own statement about the meeting, Argentina’s National Administration of Drugs, Foods, and Medical Devices said its representatives had presented on becoming a full member of the International Council for Harmonisation last month.
On 21-23 August, Mexico will host the Pan American Network for the Harmonization of Medical Regulation (PARF), a joint initiative of the national regulatory authorities of reference and PAHO. The conference, COFEPRIS said, will “address achievements and challenges in regulatory convergence and harmonization in the Americas” and explore regulatory mechanisms “to integrate supply chains with improved standards of safety, quality and efficacy, as a public health priority.”
COFEPRIS has been among the leaders of Latin American agencies in advancing harmonization efforts, particularly those that could help Mexico get more lower-cost drugs and biosimilar medications into its public health system.
On June 20 and 21, COFEPRIS said in a separate statement, its officials met with EU representatives, including the ambassadors of Belgium and Denmark, to promote closer collaboration with the EU biopharmaceutical sector, “With the aim to exchange best practices that guarantee the resilience of health systems, the construction of international alliances for the supply of vaccines, and equal availability of medicines, thereby advancing health self-sufficiency in Latin America.”
Statement (Spanish)
Colombia convenes experts to tackle medicines supply issues
In a gesture that marks a change of tone for an agency until recently on the defensive about its long backlog of procedures and its role in exacerbating medicines shortages, Colombia’s National Food and Drug Surveillance Institute (INVIMA) convened a meeting of industry representatives, heads of healthcare systems, insurers, and officials with other agencies to brainstorm solutions.
The meeting, announced 13 June, was held to “identify and address, jointly, those situations that affect the supply of medicines in the country; promote collaboration between the different actors involved in the supply chain; and guarantee timely and adequate access to medicines by the Colombian population,” INVIMA said.
Representatives of the invited entities offered perspectives on the causes of shortages and supply-chain delays and how to best to avert them. INVIMA, for its part, pledged better public reporting about medicines at risk and updated on its progress.
INVIMA’s recently named director of medicines, Sandra María Montoya Escobar, said that the agency had now cleared 60% of its pending procedures that had been tied up in delays in recent months, with special attention paid to medicines deemed at risk of shortage, Montoya Escobar said. The number of medicines flagged by the agency as unavailable has been reduced to 10, from 30 in May.
In April 2023, Colombia’s Attorney General’s opened an investigation into INVIMA’s role in medicines shortages. In February of this year, Francisco Rossi was named agency director after a year and a half with only acting directors. Rossi quickly initiated a series of actions to reduce regulatory backlogs and medicines shortages.
In an interview with Colombia’s Caracol Radio on 21 June, Rossi said he hoped that the agency sought to assure that future product registrations take no longer than 6 months in Colombia.
Statement (Spanish)
El Salvador’s new agency slashes proposed functions
Approved by an act of the Salvadoran legislature in November 2023, El Salvador’s new Superintendency of Health Regulation (SRS) was originally scheduled to have four management divisions: pharmaceutical products, food and beverages, products for agricultural use, and surveillance. On 19 June these were reduced to two by the same legislature: registrations (or authorizations) and surveillance. Noé Geovanni García, head of the country’s national Directorate of Medicines (DNM) one of the agencies in the process of being dissolved to create the new entity, explained to legislators that the changes were to make the new agency – expected open in August – more efficient and responsive.
ElSalvador.com
Latin America urged to follow Spain’s example on clinical trials
Brazil, Argentina, Mexico and Chile lead Latin America in the number of clinical trials underway, but they all lag European countries with similar-size populations, according to presenters at a 13 June seminar in Santiago, Chile. The proposed solution: follow the Spanish example.
At the seminar, sponsored by a Chilean pharmaceutical trade group and the United Nations’ Economic Commission for Latin America and the Caribbean (CEPAL), Amelia Martín Uranga, director of clinical investigations for the Spanish trade group Farmaindustria, presented on Spain’s transition to a trials leader over the past two decades, according to a statement by the trade group.
Between 2004 and 2006, Spain began changing rules that had made it less competitive for clinical research and began investing more heavily in trial infrastructure through a public-private research and development collaboration called BEST, Uranga reported. Last year 2023 Spain saw more than 4,600 trials, up from 117 in 2004, according to the BEST website.
The Spanish example may not be an easy one for Latin American countries to follow, given the relative strength of Spain’s national health system and the advantage of a harmonized platform for trial sponsors and regulators across the European Union.
CEPAL, in its statement, estimated that Latin American countries had the capacity to grow their current number of trials by fourfold. However, the agency added, “for this to become a reality, it is essential to follow the example of leading countries and join forces to build a community that promotes the … reduction of barriers to its implementation.”
Statement (Spanish)
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