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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

 

 
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Jamaica: Ministry of Health delivers Complaint Management System

The Standards and Regulations Division of the Ministry of Health, with support from Health Policy Plus (HP+), has published a Complaint Management System (CMS) Manual and Toolkit that is to inform the delivery of health services to the public.

With the Ministry’s increased focus on patient-centred care, the manual forms part of its ongoing efforts to strengthen its Client Complaint Mechanism (CCM) and overall CMS.

  • The CMS aims to improve the quality of service delivery in the public health sector by, among other things:
  • collecting feedback from internal and external clients;
  • providing a means for failures and/or complaints to be investigated; and
  • providing redress to clients.

This current manual is now aligned with the International Organisation for Standardisation (ISO) 9001, Quality Management Systems – Requirements (2008) and outlines clear processes for accessing, documenting, investigating and resolving customer complaints.

It also includes a monitoring and evaluation framework that ensures complaint data is captured for quality improvement activities and programme and policy development.

For more information go to https://www.moh.gov.jm/health-ministry-delivers-complaint-management-system-manual-toolkit/

 
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Anvisa: Jarbas presents the 2017 Activities Report to Senators

[Original text in Portuguese]

Reduced queues for drug certification and analysis time for rare disease treatments are among the major breakthroughs.

Reduction of the queues for drug certification and the time of analysis for treatments of rare diseases, and increased import of products destined for research are among the main advances of Anvisa in 2017 presented by the CEO Jarbas Barbosa. He attended the Social Affairs Committee (CAS), chaired by Senator Marta Suplicy (MDB-SP), on Wednesday (4) to detail the Agency’s Activities Report 2017.

For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4615665

 
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CRS Reviews Its First Reproductive Health Product

The CARPHA/CRS recently reviewed and recommended to CARICOM Member States its first reproductive health product, Levoplant. The product, made by Shanghai Dahua Pharmaceutical Co., Ltd., was prequalified by the World Health Organization on June 30, 2017, meaning it meets the United Nations standards of safety, efficacy, and quality for all its procurement programs. It has also been approved for country program purchase by the United Nations Population Fund. The CRS verified that the product the manufacturer intends to sell in CARICOM is the same as the prequalified version.

The active ingredient, levonorgestrel, prevents pregnancies by inhibiting or altering ovulation and thickening the cervical mucus. The product provides long term (up to 3 years of use) but reversible contraception, and becomes active when inserted into the upper arm. CARICOM Member States will now have an additional option for quality, affordable hormonal implants if they register this medicine.

More information about the product can be found on the manufacturer’s partner websites, including FHI 360.  Click here.

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