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

[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

[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

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

[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