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With the support of PAHO, Argentina advances in the strategy to expand access to medicines

The Minister of Health of the Nation, Adolfo Rubinstein, today led the meeting of high technical level that since yesterday maintain teams of the national health portfolio and representatives of the Pan American Health Organization (PAHO) for the region, with the objective of moving forward jointly in the strategy of expanding access to low-cost medicines and establishing new criteria for coverage of medical technology, one of the main axes of management.

“Two of the ministry’s main objectives are related to expanding access to medicines based on price reductions and improving the coverage conditions of medical technologies, in relation to more objective, more explicit and more transparent criteria” , defined Rubinstein.

The official stressed in that sense that “PAHO is an institution with a lot of experience and expertise and this is a working meeting with the technical team of the agency and the technical teams of the ministry, the ANMAT and the different departments that work in these issues, to agree on the strategies to improve those objectives, “he said after referring that the meeting also served to analyze the guidelines related to the registration, authorization and control of medicines.

For more information go to https://www.argentina.gob.ar/noticias/con-apoyo-de-la-ops-argentina-avanza-en-la-estrategia-para-ampliar-el-acceso-medicamentos

 
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Salvadoran regulation system advances

El Salvador receives experts from the Pan American Health Organization (PAHO) for the process of reevaluation of the country’s Pharmaceutical Regulatory System, within the framework of the certification process, whose objective is to reach Level IV, granted by this international organization.
This evaluation is carried out from July 17 to 20 at the facilities of the National Directorate of Medicines (DNM). In this stage, the modules referring to the National Pharmacovigilance System, integrated by the MINSAL and the DNM, are evaluated.

Among the appointed evaluators is Dr. José Peña, leader of the evaluation team, Dr. Ariel Arias, pharmacovigilance expert of Health Canada and Dr. Murilo Freitas, regional advisor of PAHO. At the opening ceremony were present the heads of the two institutions involved, Dr. Violeta Menjívar, Minister of Health, Dr. Julio Robles Ticas, Deputy Minister of Health Services, Dr. Leonor Morales de Acosta, National Director of Drugs and Dr. Hilda Leal, health services systems consultant for OPS, El Salvador.

For Dr. Menjívar this is a transcendental step in the development of the country and considers that a strong regulatory authority also strengthens the national pharmaceutical industry, guaranteeing the quality, safety and efficacy of medicines and giving it international prestige.

Dr. De Acosta expressed that: “Strengthening as a health agency has been possible thanks to the decided support of the Government of the Republic through President Salvador Sánchez Cerén, and also to the accompaniment by the holders of the Ministry of Health who have placed pharmaceutical regulation as a priority issue in the country’s agenda “.

The head of the National Directorate of Medicines also thanked the support that other countries have given El Salvador, to strengthen its regulatory powers, including: Chile, Cuba, Mexico, Brazil, Colombia, Spain, Argentina, among others.

“The horizon of all our actions is the health of the population, guaranteeing safe, effective, quality medicines at a fair price” and “we are ready for the re-evaluation of the Regulatory System” concluded Dr. de Acosta.
More information through the link in Spanish http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/269-proceso-de-reevaluacion

 
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Paraguay: suspension of commercialization of some medicines with the active ingredient Valsartan. DNVS communication D.G No. 02/18

The National Directorate of Health Surveillance informs that, in view of the warning issued by the EMA, the Spanish Agency of Medicines and other International Regulatory Agencies, in a preventive manner and considering that this situation represents a health risk, this Ministerial Dependency provides for the suspension of commercialization, placing in quarantine, market recall and subsequent destruction of the drug lots listed in the attachment for the active ingredient Valsartan alone or in association with another drug, from the company ZHEJING HUAHAI, Lindai, China,

More information by the link: https://www.mspbs.gov.py/dnvs/15387/comunicado-dnvs-dg-n-0218.html

 
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Peru: Digemid arranges the recall of products with valsartan after warning about possible carcinogenic impurity

104 lots of 33 products were immobilized for patients with high blood pressure.
The Directorate General of Medicines, Supplies and Drugs (Digemid), of the Ministry of Health (Minsa), ordered the withdrawal of 33 products containing valsartan (active ingredient used for arterial hypertension) in response to alerts issued by the European Medicines (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS), which warned of having found a probably carcinogenic impurity.

For more information go to https://www.gob.pe/institucion/minsa/noticias/15464-digemid-dispone-el-retiro-de-productos-con-valsartan-tras-alerta-sobre-posible-impureza-cancerigena

 
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CUBA: WITHDRAWAL FROM THE MARKET OF SOME LOTS OF MEDICINES CONTAINING VALSARTAN.

On July 5, 2018, the Spanish Agency for Medicines and Health Products (hereinafter, AEMPS) has issued the Information Note 8/2018 in which it announces the detection of N-Nitrosodimethylamine (NDMA) φ in the active ingredient Valsartan manufactured by Zhejing Huahai Pharmaceutical Co. (Ltd (BS 1) Channan Site, RC-317016 (China) .This impurity has been generated as a consequence of a change in the manufacturing process of valsartan authorized by EDQM (acronym in English). European Directorate for the Quality of Medicines & HealthCare, European Directorate for the Quality of Medicines) of the Council of Europe This alert affects multiple countries at European and global level In the case of Spain, it affects several presentations of medicines that include valsartan produced by that manufacturer and that has been distributed in many countries.In Spain, after receiving the corresponding investigation has proceeded to order the withdrawal of medicines affected two.

More information by the link http://www.cecmed.cu/sites/default/files/adjuntos/vigilancia/notas/retirada_del_mercado_de_algunos_lotes_de_medicamentos_que_contienen_valsartan.pdf 

 
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ARGENTINA: THE ANMAT INDICATES REFRAIN FROM ACQUIRING AND USING VALSARTAN RAW MATERIAL FROM A CHINA PLANT

The ANMAT instructs holders of medicinal certificates to refrain from acquiring and using the active ingredient (IFA) VALSARTAN, prepared by Zhejiang Juahai Pharmaceutical Co. Ltd, Channan Site, RC-317016, China. The recommendation is based on statements issued by the European Medicines Agency (EMA) and by the Spanish Agency for Medicines and Healthcare Products (AEMPS), as a result of which the processor detected a potentially cytotoxic impurity (N-nitrosodimethylamine) in the pharmaceutical ingredient active Valsartan, after a change in the manufacturing process of the IFA. This Administration is evaluating the pertinent sanitary measures to take, as a consequence of this episode.
Source: http://www.anmat.gov.ar/comunicados/Valsartan_China.pdf

 
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Uruguay: Preventive withdrawal of medicines containing VALSARTAN

[Original information in Spanish]

The European Medicines Agency (EMA) recently reported that one of the manufacturers of the active ingredient Valsartan, Zhejing Huahai Pharmaceutical Co. Ltd. Channan Site, RC-317016, China, identified the presence of an impurity in the batches manufactured and marketed to various pharmaceutical companies worldwide.

For more information go to http://www.msp.gub.uy/noticia/retiro-preventivo-de-medicamentos-conteniendo-valsartan

 
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El Salvador: DNM participates in the event “Access, Monitoring and Economic Regulation of the Medicines Market, including Antibiotics”, organized by ANVISA and PAHO

In the context of the convention called “Access, Monitoring and Economic Regulation of the Medicines Market, including Antibiotics”, organized on the initiative of the Secretariat of the Chamber of Regulation of the Medicines Market (SCMED) of ANVISA, with the collaboration of PAHO Brazil, and carried out at the PAHO / WHO facilities in Brasilia, on July 2 and 3, 2018.

Source in Spanish: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/268-dnm-participa-en-la-convencion

 
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WHO Essential Medicines & Health Products Annual Report 2017 – Towards access 2030

The Essential Medicines and Health Products (EMP) annual report presents highlights of results and the impact on access to quality medicines, vaccines and other health products in 2017, thanks to fruitful collaboration with all partners. Developed by the Access to Medicines, Vaccines and Pharmaceuticals cluster, the report also gives a brief overview of future plans to ensure our active contribution to the achievement of universal health coverage, which is a main priority for WHO under the SDG agenda.

To access the report click here 

 
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Avaliação comparativa das apresentações de somatropina disponibilizadas pelo SUS e demais comercializadas no Brasil/Comparative assessment of somatropin presentations provided by the Brazilian Health System and the other commercialized in Brazil/La evaluación comparativa de presentaciones de somatropina ofrecidas por el Sistema de Salud Brasileño y demás comercializas en Brasil

Avaliação comparativa das apresentações de somatropina disponibilizadas pelo SUS e demais comercializadas no Brasil/Comparative assessment of somatropin presentations provided by the Brazilian Health System and the other commercialized in Brazil/La evaluación comparativa de presentaciones de somatropina ofrecidas por el Sistema de Salud Brasileño y demás comercializas en Brasil.

Fuente:  http://sites.bvsalud.org/redetsa/brisa/resource/?id=biblioref.referencesource.878856#.W0Zf2tJKhpg