The Brazilian Health Surveillance Agency (Anvisa) certified for the first time in Good Manufacturing Practices (GMP) two Colombian pharmaceutical laboratories without a visit, which is based exclusively on inspection reports of the National Institute of Food and Drug Surveillance (Invima).

The certified laboratories are: Procaps S.A (Barranquilla) and Eurofarma Colombia S.A.S. (Bogotá).

This important achievement is based through the level of recognition that Invima gained by being a National Regulatory Authority of Regional of Reference (NRAr) level VI by the Pan American Health Organization (PAHO), indicating that the agency has uniform and transparent methodologies for the fulfillment of its functions of control, efficacy, safety and quality of medicines. Likewise, ANVISA is also recognized as one of the eight NRAr.

Source: https://www.invima.gov.co/primeros-laboratorios-farmac%C3%A9uticos-colombianos-certificados-en-bpm-por-anvisa-sin-visita.html

[5-14-2018] The Food and Drug Administration is advising consumers not to purchase or use Best Candy, a product promoted as an energy booster on various websites and possibly in some retail stores. This product was identified during an examination of imported goods.

FDA laboratory analysis confirmed that Best Candy contains nortadalafil. Nortadalafil is structurally similar to tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Health care professionals and patients should report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

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For more information go to:  https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm607663.htm

En el próximo viernes, 18 de mayo, as las 11hs (ETS), será realizada la 22da edición del programa de Webinars de RedETSA, el próximo viernes, 18 de mayo, a las 11hs (EST).

El Dr. Carlos Eduardo Pinzón-Flórez, Subdirector de Evaluación de Tecnología en Salud del Instituto de Evaluación Tecnológica en Salud (IETS), Colombia, dará una presentación sobre “Incorporación del valor social y la perspectiva de pacientes y ciudadanos en el desarrollo de la ETS”.

El link de WebEx que utilizaremos es el siguiente: https://goo.gl/238dg9

El presente Webinar está dirigido a todos interesados en el tema “Evaluación de Tecnología en Salud (ETS)”.

A continuación está disponible una tabla con el horario correspondiente a cada país.

Contamos con su presencia.

Equipo RedETSA y HSS/MT

Horario Webinar –  viernes 18 de mayo:

Red de Evaluación de Tecnologías en Salud de las Américas – RedETSA

[Original text in Spanish]

The National Directorate of Medicines of El Salvador (DNM) and the National Health Surveillance Agency of Brazil (ANVISA) exchange experiences on pharmacovigilance in the framework of the Bilateral Cooperation Program between El Salvador and Brazil 2017-2019.

Both Medicines Regulatory Authorities develop training among their members and the pharmaceutical industry to strengthen health surveillance and regulation. Part of these activities were developed in the facilities of the DNM, on dates of May 7 to 10, 2018.

The training program was attended by Adalton Guimarães Ribeiro, Technical Director of Pharmacovigilance and Fernanda Simioni Gasparotto, Specialist in Health Regulation and Surveillance of ANVISA.

The specialists provided technical knowledge for the sector of the pharmaceutical industry on specific topics such as: Pharmacovigilance Master File, Minimum Standard Operating Procedures for the operation of a Pharmacovigilance system in the Industry, Pharmacovigilance Inspections in the Pharmaceutical Industry, Periodic Safety Updat Report, Risk Management Plan, and Spontaneos Adverse Events Report.

For more information go to http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/261-dnm-y-anvisa

The President of the Republic Salvador Sánchez Cerén, this day, was sworn in to Dr. Leonor Morales de Acosta as National Director of Medicine.

The swearing in took place in the Presidential House Honor Room. It should be noted that Dr. Acosta already served as Director of said autonomous interim from January to date, but with this appointment the President of the Republic makes it official in the position.
The new incumbent served for six years as Executive Director of this same institution, therefore, she has the technical and scientific knowledge, as well as the capacity and leadership to assume with responsibility the leadership of the National Directorate.

With his appointment to the position, the continuity of the projects and institutional objectives outlined is guaranteed, including the Level IV Certification, granted by the Pan American Health Organization. This certification converts the National Directorate of Drugs into a Regional Reference Regulatory Authority.

Dr. Acosta, assumes the commitment to lead this great project of the nation that seeks to continue to guarantee the quality, safety and efficacy of medicines, as well as their rational use and low prices.

Source: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/259-juramentacion

COFEPRIS, FEUM and USP strengthen their bilateral cooperation

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the Pharmacopoeia of the United Mexican States (FEUM) and the United States Pharmacopoeia (USP for its acronym in English) today signed a Memorandum of Understanding which will contribute to the development and strengthening of a bilateral cooperation framework through the implementation of projects and activities that have a positive impact on the development of the health sector.

For more information go to https://www.gob.mx/cofepris/articulos/farmacopeas-de-mexico-y-de-eeuu-firman-memorandum-de-entendimiento-155888?idiom=es

The Pan American Health Organization cordially invites you to participate in the webinar “Traditional and Complementary Medicine in Primary Health Care; 40 years after Alma-Ata”, on May 8, 2018. Speakers will examine the role of traditional and complementary medicine in the context of the 40th anniversary of the Alma-Ata Declaration, the PAHO Universal Health Strategy, and the WHO Traditional Medicine Strategy 2014-2023.
The inclusion of traditional medicine is key to addressing ethnic inequities in health in the region, and it is therefore included as a central component of the intercultural approach of PAHO´s Policy of Ethnicity and Health.

DATE: May 8
TIME: 2 – 4 PM (EST)
LIVESTREAM:

• Spanish: http://bit.ly/2rfnSnD
• English: http://bit.ly/2HJFYIH

AGENDA
Opening remarks: Anna Coates, Chief, Office of Equity, Gender, and Cultural Diversity, PAHO/WHO
Moderator: Ricardo Fabrega, Regional Advisor for Integrated Health Services, Health Services and Access Unit, PAHO/WHO

PANEL

• The Role of Integrative and Complementary Practices in Primary Health Care in Brazil. Daniel Miele Amado, National Coordinator, Integrative and Complementary Practices in Health, Ministry of Health of Brazil
• The Importance of Traditional Medicine for the Ethnic Diversity of the Americas. Vivian Camacho, Indigenous rights activist, member of PAHO´s High-Level Commission for the 40th anniversary of Alma-Ata
• Integrative Health Competencies for Primary Health Care Professionals. Benjamin Kligler, National Director, Integrative Health Coordinating Center, Office of Patient-Centered Care & Cultural Transformation, Veterans Health Administration; Chair, Interprofessional Leadership Team, National Center for Integrative Primary Health Care
• Virtual Health Library in Traditional, Complementary, and Integrative Medicine for the Americas: information, collaboration, and inclusion to advance towards Universal Health. Veronica Abdala, Manager of Cooperative Information Services and Production of Information Sources, BIREME/PAHO/WHO

Closing remarks: James Fitzgerald, Director, Department of Health Systems and Services, PAHO/WHO

The event is a collaboration of the Health Services and Access Unit, the Office of Equity, Gender, and Cultural Diversity, and BIREME/PAHO/WHO.

On Wednesday, April 25th, the CARPHA/Caribbean Regulatory System (CRS) recommended its first vaccine to CARICOM states for marketing authorization/import permit.

 The product, called Euvichol-Plus, is manufactured by EuBiologics Co., Ltd. of South Korea, and is intended to protect against cholera. It is a new type of cholera vaccine that is easier to deliver in challenging field conditions and is much less costly than previous alternatives.

Although cholera is often dealt with in the context of disasters, including recent outbreaks in the CARICOM state of Haiti, an effective vaccine is an important part of a comprehensive prevention package. This vaccine is prequalified by the World Health Organization (WHO) and meets WHO’s high standards for quality, safety and efficacy.

 The CRS relied on assessment information confidentially shared by WHO, and verified documentation provided by the manufacturer to ensure it was the same product. This case demonstrates the way the CRS is facilitating access to high quality and life-saving medicines in the region.

In the context of limited human resources and financing in the many small states of CARICOM, the CRS is serving as a mechanism to  rely on trusted authorities for their reviews of products regarding safety, quality, and efficacy, and providing a regulatory channel for manufacturers to expeditiously send these same high quality products to the region.

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

Xiaoming Xu, Ph.D., Senior Staff Fellow, Office of Testing and Research, Office of Pharmaceutical Quality, CDER

The use of nanotechnology in products regulated by the FDA has been ongoing for several decades and has included foods, cosmetics, medical devices and drugs. Within the purview of FDA’s Center for Drug Evaluation and Research (CDER), there is great diversity in drug products containing nanomaterials.

There has been a steady increase in the number of approved drug products containing nanomaterials, including investigational new drugs, new drug applications, and abbreviated new drug applications (commonly known as generics). More than 60 applications have been approved since the early 1970s, and interest continues to rise.

Drug products containing nanomaterials are unique in several ways because they may take on different chemical, physical, or biological properties compared to other types of drugs. In some instances, this may impact the quality, safety, or efficacy of the product. For example, drug products containing nanomaterials may follow a different pathway in the body compared to a small molecule drug. After a drug product formulated as a nanomaterial enters the bloodstream, it could interact with specialized immune cells called macrophages, which engulf and transport a drug to the location for which it has been programmed, such as where bacteria, fungi, or viruses reside. These areas are typically difficult to reach for a small molecule.

In another example, a drug formulated as a nanomaterial may have a special “coating” that prevents it from interacting with immune cells so that the drug can circulate in the bloodstream for prolonged periods of time until it reaches tumor tissues. The ability to target areas of the body and bypass others can significantly reduce the risk of side effects, such as toxicity to nontarget organs, and potentially increase the effectiveness of the treatment. For these reasons, nanomaterials are most frequently used in the treatment of cancer or infections. Formulations like liposomes, nanocrystals and nano-emulsions are among the most common types of drug products containing nanomaterials being approved.

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For more information go to https://www.fda.gov/Drugs/NewsEvents/ucm605837.htm