From September 18 to 20, ANMAT is attending at the International Medical Devices Regulators Forum (IMDRF), in the city of Beijing, People’s Republic of China. In this context, the Administration was distinguished to represent the Pan American Health Organization (PAHO / WHO) to present the work and the regulatory updates, regarding the aforementioned products, in the Americas region.

For more information go to https://www.argentina.gob.ar/noticias/anmat-participa-en-importante-foro-internacional-sobre-dispositivos-medicos

The Institute of Public Health of Chile (ISP), together with the Ministry of Health of Chile and the Pan American Health Organization PAHO/WHO are organizing the XV International Meeting of Pharmacovigilance of the Americas. The event will be held on October 11th and 12th, 2018.

This event is an open call that brings together: the regulatory agencies of the Americas region, PAHO/WHO, health professionals, healthcare centers, the academy and the pharmaceutical industry, with the objective of discussing mainly, issues related to pharmacovigilance, safety and rational use of medicines. The realization of these annual meetings, have generated great impact on drug safety issues, allowing the strengthening of pharmacovigilance activities in the countries of the region. The first eight versions of these meetings took place in Colombia. Since 2012, this event has rotated through different countries of the region, including: Brazil, Peru and Panama. This year and for the first time, Chile was chosen to host this important meeting, a unique instance to listen to important pharmacovigilance experts.

For more information go to http://www.ispch.cl/encuentrofarmacovigilancia_en/presentacion

The Minister of Health, Dr. Giselle Amador, received the final recommendations from the special mission of the International Atomic Energy Agency (IAEA). The recommendations were presented by Mr. Ahmad Al Khatibeh, Head of the Delegation, advisor, of the Department of Technological Safety and Nuclear Safety.

The work visit was at the request of the Ministry of Health of Costa Rica, to the IAEA, with the intention of strengthening its role as regulatory authority in radiological safety. The 3 days of work included an integrated review of the regulatory framework for the advice process and delivery of recommendations.

For more information go to https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2018/1329-organismo-internacional-de-energia

The ANMAT and the Ministry of Health of Mexico, through its Federal Commission for the Protection against Sanitary Risks (Cofepris), signed an inter-institutional agreement on inspection records.

The objective is to facilitate cooperation in the exchange of inspection records in the pharmaceutical industry to “promote the development of a unified mechanism for the validation of inspections to verify compliance with Good Manufacturing Practices for Medicines”.

This agreement is part of the fulfillment of the commitments assumed in 2012 by the National Regulatory Authorities of Regional Reference to implement mechanisms for the exchange of inspection reports on Good Manufacturing Practices.

Source: https://www.argentina.gob.ar/noticias/anmat-y-cofepris-firman-acuerdo-para-facilitar-el-intercambio-de-actas-de-inspeccion-en-la

The Office of the Prosecutor General of the Nation (FGN) captured 14 people (12 Invima officials, 1 intermediary and 1 businesswoman) for allegedly managing and issuing health records with false documents, marketing confiscated products, altering or disappearing sanctions and conducting non-formal prior audits that supposedly guaranteed to overcome with success the official inspections that the Institute does.

These captures are the result of an investigation initiated by the FGN in 2016 thanks to the complaints presented by the General Directory of Invima. The Director General of Invima, Dr. Javier Humberto Guzmán Cruz, and the Attorney General of the Nation Doctor Nestor Humberto Martinez, made the case known to the country at a press conference on August 29, 2018.

For more information go to https://www.invima.gov.co/la-lucha-frontal-contra-la-corrupci%C3%B3n-y-la-ilegalidad-da-frutos-en-un-proceso-iniciado-por-la-direcci%C3%B3n-general-del-invima-en-2016

The Honduran Delegation had technical meetings, during three days, to know the organization, normativity, operation and results of the COFEPRIS.

The Honduran Delegation, during three days of this week, had technical meetings to know the organization, normativity, operation and results of the COFEPRIS; They visited the Commission for Analytical Control and Extension of Coverage (CCAyAC) where they learned about the various analytical processes, resolutions and technical opinions for food, medicines and medical devices.

The Federal Commissioner, Julio Sánchez and Tépoz, received the Honduran delegation in their offices, and spoke to them about the strengthening of the Mexican regulatory system and that COFEPRIS, being a National Level IV Reference Agency, is mandated to support the strengthening of other regulatory authorities. He also commented on the international programs of PAHO / WHO that they can access to modernize their operation for protection against health risks.

It was agreed to define a work plan for the implementation of recommendations in the ARSA by COFEPRIS, establish direct communication channels between both regulatory agencies and work on a collaborative instrument to formalize and promote cooperation ties.

For more information go to https://www.gob.mx/cofepris/articulos/agencia-de-regulacion-sanitaria-de-honduras-recibe-asesoria-de-la-cofepris-173069?idiom=es

Survival – The Year No-One Could Have Expected

On the evening of 18th September 2017, a merciless Maria passed over Dominica as a Category 5 hurricane, striking with winds in excess of 175 miles per hour, reshaped Dominica’s social, physical and economic landscape and threaten the future viability as a nation.

Currently, the Government has presented on July 2018 The National Budget Of The Commonwealth of Dominica Fiscal Year 2018 – 2019, “From Survival, To Sustainability And Success: A Resilient Dominica”.

This important document addressed that the Ministry of Health and Social Service will focus on the seven (7) pillars of World Health Organization (WHO)/Pan American Health Organization (PAHO) which capture the building blocks for health systems strengthening. These are service delivery, health workforce, health information system, access to essential medicine, financing, leadership/governance and community participation.

For more information go to

http://finance.gov.dm/budget/budget-addresses/file/27-budget-address-2018-2019-from-survival-to-sustainability-and-success-a-resilient-dominica

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, September 18, 2018, at 1:00PM (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs. This webinar will introduce the general characteristics of Narrow Therapeutic Index or NTI drugs and discuss FDA’s innovative approach and criteria for generic NTI drug equivalence evaluation. In addition, we will discuss results from a bioequivalence study comparing brand and generic tacrolimus (an NTI drug) capsules in stable transplant patients to address patients’ and health practitioners’ questions regarding substitutability of generic immunosuppressant drugs.

For more information go to https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm617474.htm

The Ministry of Health of Uruguay publishes a modification of the Therapeutic Drug Formulary that adds treatment of retinitis due to cytomegalovirus in patients with HIV infection to the VALGANCICLOVIR medicines coverage plan and incorporates the treatment of patients with Hepatitis virus infection C for the association of SOFOSBUVIR + VELPATASVIR.

Source: http://www.msp.gub.uy/sites/default/files/archivos_adjuntos/3-6989-2018.pdf