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.
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.
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.
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.
In order to provide advice on self-care and safe consumption to Colombians, the National Institute for Surveillance of Drugs and Food (Invima) launches its new bulletin “Cuidamos tu Salud”.
This publication has 5 sections, designed to offer recommendations for safe consumption and alert citizens about inappropriate practices and habits of the products they use and consume on a daily basis that may affect their health.
Be there for someone else. Give blood. Share life. 14 June 2018 Every year, on 14 June, countries around the world celebrate World Blood Donor Day. The event serves to thank voluntary, unpaid blood donors for their life-saving gifts of blood and to raise awareness of the need for regular blood donations to ensure the quality, safety and availability of blood and blood products for patients in need.
Transfusion of blood and blood products helps save millions of lives every year. It can help patients suffering from life-threatening conditions live longer and with a higher quality of life, and supports complex medical and surgical procedures. It also has an essential, life-saving role in maternal and child care and during the emergency response to man-made and natural disasters.
A blood service that gives patients access to safe blood and blood products in sufficient quantity is a key component of an effective health system. An adequate supply can only be ensured through regular donations by voluntary, unpaid blood donors. However, in many countries, blood services face the challenge of making sufficient blood available, while also ensuring its quality and safety.
Inspections will be carried out from June 12 to 21 with the objective of reassessing the maintenance of Brazil’s status with the White List criterion.
A team of European Union (EU) auditors was at Anvisa in Brasilia on Tuesday, June 12 to begin the process of assessing the maintenance of country status included in the list of countries with equivalence in the controls of pharmaceutical supplies, called the White List.
FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.
This year, the IX CPANDRH will be held in San Salvador, El Salvador from October 24 to 26, 2018, in the Hotel Sheraton Presidente at Avenida De La Revolución, San Salvador, El Salvador.
