Prohibition became effective as of January 1, 2019. Measure is the result of the Minamata convention.

The manufacture, importation and commercialization of thermometers and pressure meters that use a column of mercury for health diagnosis is prohibited. The measure also includes a ban on the use of such equipment in health services, which will have to dispose of the solid waste containing mercury, according to the norms defined by Anvisa (Resolution of the Collegiate Board of Directors – RDC 306/2004) and Environmental Bodies (Federal and State ).

The measure was defined by the Resolution of Collegiate Board of Directors – RDC 145/2017, and entered into force on Tuesday (1/1). The prohibition of thermometers and sphygmomanometers, as technically called mercury column pressure meters, is a result of the Minamata Convention. The convention was signed by Brazil and 140 countries in 2013 and aims to eliminate the use of mercury in different products such as batteries, lamps and health equipment, among others.

For more information go to ANVISA

The Caribbean Regulatory System (CRS) recently recommended its first non-communicable disease (NCD) medicines, including amlodipine for high blood pressure and anastrozole for breast cancer. The Caribbean is the worst affected sub-region in the Americas for NCDs, which are a leading cause of premature mortality, making up about half of all deaths of people under 70.

The recommended medicines are some of the most important tools that health providers and patients have to correct dangerous conditions like high blood pressure and cancer. For example, amlodipine is recognized as a critically effective blood pressure lowering medicine and is one of the most highly purchased products in the sub-region. Anastrozole is a key treatment in breast cancer and is listed on the World Health Organization’s (WHO) list of essential medicines.

Commenting on the development Dr. Virginia Asin-Oostburg, Director of Surveillance, Disease Prevention and Control at CARPHA who manages the CRS programme said, “This marks an important new milestone for assuring quality NCD medicines in the region, where we know regulatory capacity can be limited due to small populations and few human resources.“  She further noted that each medicine has to be pre-approved by a strong regulatory authority like the United States Food and Drug Administration or the World Health Organization, and be suitable for the Region, before it can be recommended by the CRS to CARICOM member states.

There are more NCD medicines under review at the CRS, and a goal of the program is to have recommended quality versions of all NCD medicines listed on WHO’s list of essential medicines.

Source: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS

The National Director of Drugs, Dr. Leonor Morales de Acosta presented the report of accountability for the period from June 2017 to May 2018, in which she highlights important achievements.

Dr. de Acosta, highlighted that now El Salvador has a market of quality medicines and fair prices, also reported that the market has been revitalized with the registration of more than 6 thousand new medicines which guarantees the supply and availability of more therapeutic options for patients.

“Another achieved unprecedented for the Central American region has been the regulation of retail prices, El Salvador now has the lowest prices in the region, consequently the population has saved a significant amount of money, in these 6 years saving in the pocket has been about 500 million dollars, “said the head of the DNM.

For more information https://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/291-memoria-de-labores-2018

On December 19, 2018, the CECMED workshop was held to initiate the collection of information on the timely prevalence study of antimicrobial use, within the WHO / PAHO Project “Initiative of the National Regulatory Agencies of medicines for the containment of resistance. antimicrobial in the framework of regional and global plans on the subject “.

Hospital researchers included in this research, specialists from CECMED and from the OPS Cuba Coordination participated in it. The objective of the meeting was to update the participants on the implementation of the project and to instruct the researchers in the proposed methodology for the collection of information.

For more information go to https://www.cecmed.cu/content/constituido-el-grupo-regulador-para-la-contencion-de-la-resistencia-antimicrobiana-en-cuba

–       35 countries are meeting in El Salvador to exchange knowledge and experience in the pharmaceutical regulation.

–       National Drugs Directorate, in coordination with the Pan American Health Organization (PAHO) and the World Health Organization (WHO), held from 24 to 26 October 2018, the Conference of the Pan American Network for Harmonization of Drug Regulatory Authorities (CPANDRH) where all the countries of the Americas participate.

This is the first time a Central American country is hosting a meeting of this level where regulatory strategies for drugs and medical devices are discussed aimed at improving the quality of life and health care to citizens of member countries of the Americas.

The purpose of this meeting is to exchange knowledge and experience in the pharmaceutical regulation to promote action for the health of the population. Through cooperation among the countries of America can strengthen regulatory measures to ensure that patients have access to safe, effective and quality medicines.

The CPARF is a continental forum coordinated by PAHO / WHO where drug regulatory authorities, representatives of national and international pharmaceutical industry, academics and representatives of professional health associations involved.

The main topics to be discussed at this meeting include: Antimicrobial resistance and control activities, regulation in promoting access and universal health coverage, the current challenges of the regulation of medical devices in the region, strengthening regulatory systems in the region: the impact of global programs to strengthen regulatory systems, access to medicines and other essential technologies.

For more information go to http://ixcparf.medicamentos.gob.sv/index.php/en

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

What is FAERS?

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

For more information go to https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm

On Friday, December 23, the Institute of Public Health of Chile (ISP), participated in the Forum of Cooperation between Korea and Chile for the Health Industry, organized by the Embassy of the Republic of South Korea together with the Institute of Development of Korea Health Industry (KHIDI) at the Hyatt Centric hotel.
The objective of the forum was to share the current state of the pharmaceutical, cosmetic and medical devices (DM) industry, in both countries, in addition to the exchange of information among the participants to strengthen the benefits of the cooperation that exists between South Korea and Chile. .
(…)
The South Korean authorities referred to issues of import, export and growth in medicines, cosmetics and medical devices. While the ISP referred to issues on health registration in Chile, innovation in the area of ​​cosmetics, the legal framework of medical devices and the amendment to the Health Code, known as the “Law of Drugs II.”

Source: http://www.ispch.cl/noticia/27429