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.
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).
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.
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.
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.
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.
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.
The May 2018 issue of the digital journal of the Medicines Information Association (DIA), entitled DIA Global Forum, aimed at offering global and regional expertise on the discovery, development, regulation, surveillance and commercialization of products for the health, presents an article on the Certificate of Pharmaceutical Product (CPP)Project written by the focal points of the project, D.S Celeste Sánchez in CECMED and Dr. Jaime Oliveira in FIFARMA, named “CPP Requirements for Medicines Registration in the Region of the Americas. A PANDRH CPP Project “. Access to the full text of this work is here.
We hope you enjoy reading the article and join the CPP Project Community in the PRAIS Platform of PAHO where you can find additional information about the Project.
OTTAWA – With the growing availability of fentanyl test strips on store shelves and online, Health Canada would like to remind Canadians of the potential limitations when using fentanyl test strips to detect fentanyl or other deadly substances in street drugs before consuming them.
No fentanyl test strips are specifically designed to check street drugs before consumption. Some strips are designed to detect fentanyl and some analogs (similar chemicals, such as carfentanil) in an individual’s urine sample to determine whether they have taken the drug. Others are designed to detect fentanyl and some analogs in substances that are, for example, seized by law enforcement. Therefore, it is important that people who are using fentanyl test strips to check street drugs before consuming them understand the limitations and use the necessary precautions.
Health Canada is reminding Canadians that to help prevent a fatal overdose, it is important to treat all street drugs as though they are potentially contaminated with unknown deadly substances.
During the period, Anvisa and the National Health Surveillance System (SNVS) were submitted to the European Union’s audit whose main objective was “to evaluate the regulatory framework applicable to API for human use / 2014-2018 period.”
During the two weeks, the European Community auditing team, Anvisa representatives and local health surveillance visited manufacturers of IFAs in the states of São Paulo, Piauí and Minas Gerais.
