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Information for laboratories on medicines quality control analysis for INVIMA

The National Institute for Medicines and Food Surveillance (INVIMA) informs laboratories of quality control of medicines in the country, that the process of authorization of laboratories for various products and methodologies is underway.

Access the link for more information: https://www.invima.gov.co/informaci%C3%B3n-para-los-laboratorios-que-quieran-realizar-an%C3%A1lisis-de-medicamentos-para-el-invima.html

 
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Health Canada reminds Canadians of the limitations of fentanyl test strips being used to check street drugs before consumption

Posting date: June 22, 2018

OTTAWA – With the growing availability of fentanyl test strips on store shelves and online, Health Canada would like to remind Canadians of the potential limitations when using fentanyl test strips to detect fentanyl or other deadly substances in street drugs before consuming them.

No fentanyl test strips are specifically designed to check street drugs before consumption. Some strips are designed to detect fentanyl and some analogs (similar chemicals, such as carfentanil) in an individual’s urine sample to determine whether they have taken the drug. Others are designed to detect fentanyl and some analogs in substances that are, for example, seized by law enforcement. Therefore, it is important that people who are using fentanyl test strips to check street drugs before consuming them understand the limitations and use the necessary precautions.

Health Canada is reminding Canadians that to help prevent a fatal overdose, it is important to treat all street drugs as though they are potentially contaminated with unknown deadly substances.

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For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67106a-eng.php

 
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Anvisa maintains status in the European Union for pharmaceutical supplies

During the period, Anvisa and the National Health Surveillance System (SNVS) were submitted to the European Union’s audit whose main objective was “to evaluate the regulatory framework applicable to API for human use / 2014-2018 period.”

During the two weeks, the European Community auditing team, Anvisa representatives and local health surveillance visited manufacturers of IFAs in the states of São Paulo, Piauí and Minas Gerais.

Source: ANVISA

 
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ANMAT will host a meeting to conclude the development of the regulatory systems assessment tool

[Original text in Spanish]

ANMAT, one of the eight authorities recognized as a regional reference in medicines of PAHO / WHO in the Americas, will host a meeting on the development of a regulatory systems assessment tool.

The meeting will take place from July 23 to 25 in Buenos Aires, Argentina, and will have the participation of global regulators representatives. Among the objectives of the meeting are:

  • Improve the global assessment system for regulatory systems (GBT) according to the recommendations of the public consultation and feedback process of the representatives of the National Regulatory Authorities (ARNs) that have provided advice to WHO and PAHO.
  • Provide recommendations to the editor of the tool.
  • Support the development / definition of quantitative indicators to be included in the tool.
  • Discuss the training requirements and competencies of the evaluators.

Source: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf

 
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Dominican Republic: Ministry of Health publish new basic List of Essential Medicines 2018

[Original Text in Spanish]

SANTO DOMINGO.-The Dominican Government through the Ministry of Health guarantees access to essential medicines with the implementation of the 7th version of the Basic List of Essential Drugs, with 797 selected drugs. This selection was made based on scientific evidence and through the use of a systematized methodology that considered the national epidemiological profile, the different levels of care, clinical therapeutic guidelines and care protocols, thereby complying with the General Law of Health 42-01.

Compared to the version of 2015, the Basic List of Essential Medicines 2018, has 35 additional drugs, in the following categories: psychoactive drugs, cardiovascular, analgesics, antibiotics, antiepileptic drugs, contraceptives, tuberculosis treatments and HIV medicines for hepatitis B and C.

More information on the link http://www.msp.gob.do/MS-oficializa-Cuadro-Basico-de-Medicamentos-Esenciales-2018

 
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MERCOSUR: agreements between the health ministers of Mercosur to strengthen the capacities of national regulatory authorities (ARN) and joint negotiation for the acquisition of high-priced medicines.

The Mercosur health ministers met in Asunción, Paraguay, and on the occasion agreed on relevant decisions on central issues of the region’s public health agenda.

Among them, the signing of a declaration that promotes the strengthening and qualification of the capacities of national regulatory authorities (NRAs) to ensure the convergence and regulatory harmonization between the States Parties and Mercosur partners stands out.

On the other hand, Mercosur’s line of work on joint negotiation for the acquisition of high-priced medicines ratified what had been done so far and the ad hoc group was instructed to resume its work during the Presidency Protémpore of Uruguay.

Source: http://www.msp.gub.uy/noticia/la-salud-del-mercosur

 

http://www.msp.gub.uy/noticia/la-salud-del-mercosur

 

 
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Anvisa: Food supplements will have unique set of rules

[Original text in Portuguese]

Food supplements will be treated as a single category of products, which will make the regulation on the subject in Brazil more lean and safe. In general, the proposal is to bring together in a single set of standards all health legislation and guidelines for manufacturers of these products.

The initiative is the National Sanitary Surveillance Agency (Anvisa), which, along with the regulated sector and entities interested in the subject, is promoting a broad review of the current standards that must be followed by the industry.

To meet this goal, the body held six public consultations between January and April of this year to receive contributions and suggestions from companies, government, universities, consumer organizations and society in general. The main results and analyzes of the consultations were presented to approximately 120 people on Monday (11), between 9am and 5pm, in the auditorium of Anvisa, in Brasília.

At the opening of the event, the organization’s president, Jarbas Barbosa, stressed that the process of revision of the rules was intense and long, but that will bring benefits to the sector. “After living with various problems related to dietary supplements, we are now moving towards a new regulatory framework,” Barbosa said.

For more information click here

 
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Technology used in Uruguay allows a blood donor to save four lives

The National Blood Service managed to get 29,000 people to donate blood last year at the offices of Montevideo and Maldonado. The director of the service, Lourdes Viano, said that with only one donor, four lives can be saved, thanks to the technological development of Uruguay, which allows the use of all the blood components. Capturing more voluntary donors is a priority objective.

For more information go to http://www.msp.gub.uy/noticia/tecnolog%C3%ADa-utilizada-en-uruguay-permite-que-un-donante-de-sangre-salve-cuatro-vidas