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Chile: The ISP signed a memorandum of understanding with the Spanish agency for medicines and health products (AEMPS)

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

 
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Embassy of Mexico in Panama presents pharmaceutical companies to Authorities of Ministry of Health

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

 
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Ecuador: Arcsa trained customs personnel to identify counterfeit products

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/

 
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Mexico: Second International Week in Regulatory Science and Good Regulatory Practices of COFEPRIS

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

 
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DA Drug Topics: FDA Regulation of Color Additives in Drug Products – November 6, 2018

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

 
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Jamaica: 9th Annual National Health Research Conference, 2018

Registration open for National Health Research Conference

Interested persons are invited to the Ministry of Health’s 9th Annual National Health Research Conference which will be held November 22-23, 2018 at the Jamaica Conference Centre under the theme “Don’t Wish for It, Work for It!”. Abstracts on Oral Health, Intentional and Unintentional Injuries, Non-communicable Diseases, featuring cancers and Family Planning will be showcased. Registration is now open and is free of cost.

Persons are encouraged to register early to secure your conference package, which includes lunch and conference materials.

REGISTRATION LINK: https://goo.gl/forms/MdwIpEAQyqVT7UDs2

Source: https://www.moh.gov.jm/9th-annual-national-health-research-conference-2018/ 

 
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Colombia: Invima requests Facebook to eliminate 152 ad profiles and marketing of deceptive products

A total of 152 profiles were eliminated by the social network Facebook, Inc., for advertising and marketing products that violate Colombian laws and regulations putting the health of the consuming population at risk.

This measure was achieved thanks to a request sent by the National Institute for Food and Drug Surveillance (INVIMA) in which concerns are expressed about these ads for products that lack the sanitary registration or health permit required, offer unauthorized benefits and virtues. therapies that deceive consumers.

Within the URLs removed are products to “burn fat” and achieve weight loss, the brand Ultrasbelt – U.USB with different commercial presentations and marketing in several cities in Colombia.

 

Also, products of the brand XIBION, Eurofit and Ultra ZX, Nitro Fit, Airt Fit, Green Tea, Sundown Naturals, Ghee Butter, Blue Energy, among others. All were offered with quick and easy results to “burn fat and lose weight”.

 

For more information go to https://www.invima.gov.co/por-solicitud-de-invima,-facebook-elimina-152-perfiles-que-anunciaban-y-comercializaban-productos-enga%C3%B1osos-en-colombia

 

 

 
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For the first time in Chile, the 7th Global Meeting on Vaccine Safety is held

The Minister of Health, Emilio Santelices, together with the representative of WHO in Chile, Paloma Cuchí and the Director (s) of the Institute of Public Health (ISP), Judith Mora, were in charge of opening the 7th Global Meeting on Vaccine Safety, organized by the World Health Organization (WHO), which included the participation of the ISP.

The event involved around 100 attendees, from more than 40 countries representing immunization programs and regulatory authorities, whose main objective is to develop, update and competencies in pharmacovigilance of vaccines that allow access to safe vaccines in each of the member countries.

The purpose of the meeting was to interact and exchange information on the progress of the last year in the implementation of the national and global pharmacovigilance of vaccines.

More information by the link http://www.ispch.cl/noticia/27323

 
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Ecuador: Arcsa controls leave more than 22 thousand products confiscated in El Oro

So far this month, more than 22 thousand natural products without Ecuadorian Sanitary Registry have been confiscated in several controls carried out by technicians of the Zonal Coordination 7 of the National Agency of Health Regulation, Control and Surveillance (Arcsa) in different establishments of the province of El Oro, the same ones that were removed from the market by personnel of the Customs Crimes Unit of the National Police (UDAT).

These actions are carried out periodically in the premises of sale of medicines and natural products in order to verify the authenticity of the Sanitary Registry and expiration date, and thus prevent the commercialization of products that may put the health of citizens at risk.

For more information go to https://www.controlsanitario.gob.ec/controles-de-arcsa-dejan-mas-de-22-mil-productos-decomisados-en-el-oro/

 
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Ecuador: Cancellation of the Registry (marketing authorization) of medication ABCERTIN (imiglucerase)

The National Agency for Health Regulation, Control and Surveillance (Arcsa) informs the public that the Registry (marketing authorization) No. 22-MB3-0515 granted to the company ISU ABXIS CO. Has been definitively canceled. LTD., Through its legal representative MEDICAMENTA ECUATORIANA S.A., for the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.

The action responds to the fact that it has been verified that the medication has not been commercialized for a period of one year, which is why the company has the obligation to withdraw the stocks that are kept in the general market. Similarly, Arcsa requests not to commercialize, use or consume the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.

Additionally, citizens are invited to report on the sale or distribution of products without an Ecuadorian Health Registry or that come from dubious origin through the application “Arcsa Móvil”, or email farmaco.vigilancia@controlsanitario.gob.ec