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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

 
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Anvisa announced the end of the waiting list to celebrates 18 years of the first registered generic drug in Brazil

The Brazilian Health Surveillance Agency (Anvisa) has announced the end of the waiting list for analysis of applications for generic drugs by the end of August this year. This was because the agency greatly increased the speed of evaluation of requests and managed to reduce by 90% of the liabilities of petitions between April 2017 and May this year. In total, 744 applications were analyzed in the period.

The information was disclosed on Thursday morning (05) by the director-president of the organ, Jarbas Barbosa, who opened the commemorative event “18 years of access to generic medicines and Anvisa’s efficiency in registration strategies” held in the auditorium of the institution’s headquarters, in Brasília (DF).

Source in Portuguese: ANVISA 

More information in Portuguese about 18 years of marketing authorization for generics medicines in Brazil is available here.

 
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INVIMA: New communication channel with the industry

Invima presents the first edition of its new “Business Bulletin”, with which it will provide information of interest to entrepreneurs.

For Invima it is essential to strengthen communication and relationship with private companies, for this reason, we have designed a publication that seeks to respond to their interests and information needs. This bulletin was built based on the results of a survey that Invima conducted to the industry, in which 2,245 people participated, of which 99% expressed their interest in receiving a publication of this type.

The bulletin has 6 sections that seek to provide information on regulatory updates, procedures and fees, training and events of the Entity, management and institutional publications.

Starting in July, and month after month, businessmen will have the opportunity to consult this newsletter, which will be available through the website www.invima.gov.co, in the Invima recommends section – entrepreneurs and social networks Of the entity.

We hope that this bulletin becomes an instrument that supports the implementation of strategies that contribute to the success of the business sector in the country.

For more information, see the bulletin here.

 
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Mexico: COFEPRIS celebrates 17 years of protection for the health and well-being of people

The Federal Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz recognized each and every one of the public servants of COFEPRIS, who with their dedicated and honest work, allow the institution to offer better services on a daily basis. He highlighted the solidarity work of the sanitary brigades, which due to the earthquakes of September last year, worked for the health care of the different affected populations.

For more information in Spanish go to https://www.gob.mx/cofepris/articulos/seguiremos-con-buenas-noticias-en-beneficio-de-la-salud-de-la-poblacion-jsyt-164000?idiom=es