From November 5 to 12, ANMAT received members of the audit team of the Pharmaceutical Inspection Co-operation Scheme (PIC / S) to re-evaluate the standards of good manufacturing practices and quality systems of its inspectorate in the field of medicines.

More information by the link https://www.argentina.gob.ar/noticias/anmat-fue-reevaluada-por-el-esquema-de-cooperacion-en-inspecciones-farmaceuticas-pics

Change Can’t Wait. Our Time with Antibiotics is Running Out

Each November, World Antibiotic Awareness Week (WAAW) aims to increase global awareness of antibiotic resistance (AMR) and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance. Since their discovery, antibiotics have served as the cornerstone of modern medicine. However, the persistent overuse and misuse of antibiotics in human and animal health have encouraged the emergence and spread of AMR, which occurs when microbes, such as bacteria, become resistant to the drugs used to treat them.

Key message for general public: Think twice. Seek Advice. Misuse of Antibiotics puts us all at risk.

Go to https://www.paho.org/hq/index.php?option=com_content&view=article&id=14750:world-antibiotic-awareness-week-2018&Itemid=72417&lang=en

Welcome

IX RED PARF

The Pan American Network for Regulatory Harmonization (PANDRH), is an initiative of the national regulatory authorities of the Region and the Pan American Health Organization (PAHO), which supports the process of harmonization of drug regulation in the Americas in the context of realities and national and subregional health policies and the recognition of pre-existing asymmetries.

The Pan American Conference on Harmonization of Drug Regulatory Authorities (CANDRH) , is a meeting of members of PANDRH held every two or three years and its mission is ” to promote the harmonization of drug regulation covering all aspects of quality , safety and efficacy of pharmaceutical products as a contribution to the quality of life and health care to the citizens of the countries of the Americas. ”

El Salvador becomes the headquarters of the ” IX Pan American Conference on Harmonization of Drug Regulatory Authorities (CPARF)” , to be held in San Salvador, on 24, 25 and 26 October 2018 under the theme “Celebrating 20 years the PANDRH and 40 years of Alma-Ata. Contributions regulatory harmonization in achieving health for all “

For El Salvador is honored to host an event of such importance, and be part of an initiative where they discussed technical and scientific standards and regulations related to pharmaceutical regulation processes; to have the opportunity to contribute to the harmonization of these strategies in order to ensure the health of the peoples of our America.

For more information go to https://ixcparf.medicamentos.gob.sv/index.php/en/

El Salvador is the headquarters of the VIII Meeting of Regulatory Authorities of Medicines, where the regulatory capacities regarding medical devices in the Americas will be strengthened.

The meeting takes place at the facilities of the National Directorate of Drugs, on October 22 and 23, 2018 and 23 Regulatory Authorities of the region and the Pan American Health Organization (PAHO) participate.

In the opening ceremony, the National Director of Drugs, Dr. Leonor de Acosta said that medical devices play an essential role in the public health network and are fundamental in treatments and therapies of high complexity, so that health agencies they have the challenge of ensuring that these products comply with the guarantees of quality and efficacy required to effectively benefit the health of patients.

Dr. Acosta expressed to the international delegates that: “this meeting will be a favorable space to exchange experiences in order to reduce the gaps identified in this issue, and in this way advance together in the consolidation of the regulation of medical devices in the regional and international plans “.

PAHO has intensified work in the area of ​​regulation of medical devices and in this sense has promoted the creation of a Regional Working Group for the Regulation of Medical Devices.

This working group was born in 2012, initially with 12 members, but currently has 20. Among the challenges of this meeting are: to reduce the gaps identified in the current regulation of medical devices in the Region of the Americas by proposing initiatives, strategies and cooperation groups among countries to promote the strengthening of regulatory capacities and advance their consolidation.

Source: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/284-viii-reunion-de-device-medicines

Source: https://pressroom.oecs.org/carphacrs-and-the-organization-of-eastern-caribbean-statespharmaceutical-procurement-service-form-partnership

The director (s) of the Institute of Public Health of Chile (ISP), Dra. Judith Mora, signed on Wednesday October 10 an agreement with the Spanish Agency of medicines and health products, (AEMPS), through his representative the Dr Ramón Palop, Chief of the Management Support Unit of this organization. The objective of the agreement is to promote cooperation on products subject to sanitary control between both countries.

The agreement also seeks to promote understanding among the signatories on their respective regulatory frameworks, requirements and processes, facilitate the exchange of information and documents related to the regulation of products subject to sanitary control, promote the development of collaborative activities among signatories and improve the capacity of signatories in the provision of services related to public health, in order to meet the needs of their respective populations.

Likewise, this agreement is intended to cover all types of products regulated by both agencies and allows for significant cooperation between them. These products include medicines, cosmetics, personal hygiene and medical devices, among others.

The activities included in the framework of the cooperation itself or in the specific work project plan will be prepared by mutual agreement and with annual review, communication channels will be established to facilitate the exchange of information on the regulation of products subject to sanitary control. each signer, including: policies, practices, standards, laboratory analysis, pre-marketing evaluation, post-marketing surveillance, regulation of producers, clinical trials and products subject to sanitary control.

Source: http://www.ispch.cl/noticia/27332

In order to strengthen commercial ties between the Republic of Panama and Mexico, the Seminar “Business Opportunities for the Health Sector in Panama” was organized, organized by the Embassy of Mexico of Panama with pharmaceutical companies that present their products and services for future negotiations. In our country.

On behalf of Panama, the Vice Minister of Health, Dr. Eric Ulloa, explained that in the country there is a Health Policy and Strategic Guidelines 2016-2025 framed in the responsibilities as the governing body of Health in Panama and other shared in search of the equity in health a right of all.

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In this regard, the Ambassador of Mexico in Panama, José Ignacio Piña, indicated that the Panama Trade Mission is an initiative of PRO Mexico, is part of the strategy of the Mexican pharmaceutical industry at an international level.

He also mentioned that Mexico is the second largest market in Latin America in the Pharmaceutical Industry and is an important producer of high-tech medicines. For 2016, in this sector reached the sum of 1,300 million dollars, while investment in this sector of 99 and 2016 was more than 8 thousand 500 million dollars.

Other important achievements are currently being the first exporter of medical devices in Latin America and the eighth globally. It is the third world exporter of instruments and equipment for medicine, surgery, dentistry and veterinary medicine; and the seventh global carrier of needle syringes for medical use, Piña added.

In 2014, the Ministers of Health of Panama and Mexico signed the cooperation agreement on medicines. The new agreement seeks to increase technical cooperation to strengthen Panama’s ambulatory capacity of health and medication registries.

Finally, the Vice Minister of Health, Dr. Eric Ulloa, thanked the Ambassador of Mexico in Panama for his deference. José Ignacio Piña and the participants of the workshop that strengthen the bilateral relationship of both countries.

Source: http://www.minsa.gob.pa/noticia/embajada-de-mexico-en-panama-presenta-empresas-farmaceuticas-autoridades-del-minsa

In order to prevent the entry of counterfeit or adulterated products across national borders, the Zonal Coordination 7 of the National Agency for Health Regulation, Control and Surveillance (Arcsa) trained the surveillance personnel of the National Customs Service of Ecuador (Senae) of Huaquillas on the identification of the Sanitary Registry, Sanitary Notification and benefits of the “Arcsa Móvil” application.

This action will allow applying the knowledge imparted at the time of the controls at the border with Peru, where the staff of the Senae can immediately identify the irregularity of a product through said application, and then trace a course of action with Arcsa to prevent it from reaching the market and being consumed by the population.

This activity is part of the inter-institutional work between Arcsa and the control authorities, with whom verifications of compliance with the Sanitary Regulations are made in the labeling of products for human use and consumption, such as Sanitary Registry, Sanitary Notification and expiration date that must be have processed foods, medicines and natural products for medicinal use.

“We know the risk of consuming a counterfeit or adulterated product, for that reason we look for actions that are within our competences that allow us to protect the health of consumers,” said Verónica Loaiza, zonal coordinator 7 of Arcsa, “we work on several preventive strategies with the other control institutions that allow us to reinforce the decrease of income of products that do not comply with the Health Regulations “.

Source: https://www.controlsanitario.gob.ec/arcsa-capacito-a-personal-aduanero-para-identificar-productos-falsificados/

Health specialists and regulatory affairs from around the world will meet from November 27 to 29 at Centro Citibanamex, Mexico City, to share knowledge and experiences about current and future threats to global health, the role of Regulatory Science and Good Health Regulatory Practices to achieve Universal Health Coverage through innovation, harmonization and regulatory convergence; dissemination and use of internationally recognized standards, learning, training and exchange of experiences in regulation and health practices.

OBJECTIVES

• Share the experiences of harmonization and regulatory convergence.
• Update the progress of Regulatory Science and Good Regulatory Practices of other countries and regional and international regulatory networks.
• Promote the population’s access to safer, more efficient and high quality products, improve the quality of health services, and promote the prevention of diseases.
• Improve cooperation and dissemination of knowledge of Regulatory Science and Good Regulatory Practices for access to health products and technologies, innovation in new therapies or related technologies, thus improving the current regulatory environment.

TOPICS TO ADDRESS
1. Emerging global threats to health.
2. Regulatory science and its contribution to health.
3. Harmonization, convergence, trust and international standards.
4. Policy and good regulatory practices.
5. Professional competences for regulatory professionals.

For more information go to https://www.dropbox.com/s/8lyniy59fvetkn7/Programa%20R%C3%A1pido%20SSI_ESP%20ING%20Interactivo_ok.pdf?dl=0

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, November 6, 2018, at 1pm (EST), CDER’s Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: FDA Regulation of Color Additives in Drug Products. The U.S. Food and Drug Administration (FDA) regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act. Color additives must be pre-approved by the FDA and listed in Title 21 of the Code of Federal Regulations before they may be used in drugs and other FDA-regulated products. This webinar will give you an overview of FDA’s regulation of color additives in drug products. You will learn about the color additive petition process and how a color additive is listed for use in drugs. You will also learn about the two types of color additives, certified and certification exempt, and how the certification process works. The webinar will discuss the labeling requirements for color additives in drug products and how FDA enforces these regulations.

For more information go to https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm623480.htm