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, June 26, 2018, at 1:00PM (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS). This webinar will introduce health care professionals to web resources about Risk Evaluation and Mitigation Strategies (REMS), including a REMS resource portal and the REMS@FDA website, and will focus on what type of information is available, where, and how to navigate these resources.

For more information go to https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm607741.htm

[Original Text in Spanish]

Santo Domingo.-A total of 797 drugs are contained in the seventh edition of the Basic Table of Essential Medicines (CBME) 2018, presented by the Ministry of Health with the purpose of expanding the population’s access to pharmaceutical products with proven safety and efficacy therapeutic, at reasonable costs.

The Minister of Health, Dr. Rafael Sánchez Cárdenas, said that the institution continues the journey of reaching the goals that have been proposed, in the sense of guaranteeing to the citizenship, safe, quality and affordable medicines, mainly to the sectors with the least resources. economic

For this year 2018, the approval of the Basic Table of Drugs was approved by all interested sectors and 28 new active ingredients were added corresponding to psychotropic drugs, tuberculosis and HIV treatments, cardiovascular, analgesics, antibiotics, antiepileptic drugs, contraceptives, medicines for hepatitis B and C.

This Basic Chart constitutes a tool for the acquisition, supply, financing and prescription of medicines. It covers medicines for the treatment of 85% of the main diseases that correspond to the epidemiological profile and morbidity of the Dominican family.

For more information go to http://msp.gob.do/MS-aprueba-nuevo-Cuadro-Basico-de-Medicamentos-Esenciales-CBME-2018-incluye-mas-de-700-farmacos

[Original Text in Spanish}

He also presented the National Strategy of Action on Resistance to Antimicrobials

The Federal Commissioner for Protection against Health Risks, Julio Sanchez and Tépoz, warned that the challenge of the health authorities in the world is to prevent and prevent in their countries are marketed low quality or counterfeit medical products, as they do not guarantee quality , safety and efficacy.

By participating in the panel “The critical role of regulation in combating low-quality and counterfeit medical products”, in the framework of the 71st World Health Assembly, in Geneva, Switzerland, held that “quality medical products Substandard and counterfeit are a risk to the health of the population and it is up to us, as regulatory authorities, to avoid commercialization in our countries at all costs. ”
“The National Drug Regulatory Authorities require increasingly diverse and complex regulatory competencies to comply with the safety and quality of regulated medical products and thereby prevent the entry into the market of counterfeit medical products of low quality in the market. The challenges are significant and could lead to various economic and public health risks that would negatively impact on mortality, morbidity, quality of life, patient and consumer productivity, as well as on the general economic well-being of the countries, “said the owner. the COFEPRIS.

Before representatives of the World Health Organization (WHO) and health authorities of various countries, stressed that the safety and quality of medical products and greater access to them, the transparency and accuracy of information in regulatory acts, as well as the adoption of timely methodologies based on evidence to remove suspicious products from the market and thus prevent damage and mitigate risks to public health, are essential to efficiently regulate potential health risks.
In another meeting, Julio Sánchez and Tépoz, with the representation of the Government of Mexico, presented the National Strategy of Action on Resistance to Antimicrobials.

The Federal Commissioner explained that the 71st World Health Assembly addressed issues of public health, environment and climate change; global shortage of medicines and vaccines and their access; global strategy and public health action plan; innovation and intellectual property; global governance to guarantee sustainable global actions; nutrition of the mother, the infant and the young child; as well as the dimension of public health in the world drug problem.

Source: https://www.gob.mx/cofepris/articulos/reto-de-las-autoridades-sanitarias-evitar-que-se-comercialicen-productos-medicos-falsos-y-de-baja-calidad-jsyt-158040?idiom=es

Resolution 75/2018 of the Center for the State Control of the Quality of Medicines and Medical Devices (CECMED) approves and enforces the Guide for the performance of pharmacogenomic studies during the development of medicines. According to CECMED, this guide is considered the first regulatory provision on the subject in the region. This provision sets the guidelines for conducting pharmacogenomic evaluations during the development of medicines of the national pharmaceutical industry.

The guide includes regulatory requirements for pharmacogenomic evaluation: the reception, coding and storage of samples, the use of biomarkers and the ethics of research. Pharmacogenomics allows therapeutic decisions to be guided by the molecular attributes of each patient, allows identifying patients who will respond to treatment, which implies an increase in therapeutic activity of incalculable scope, also has great impact in terms of safety, since the patients who will not respond, when not receiving the treatment, will be saved toxicities that would limit their quality of life, finally the impact on the efficiency, means a reduction of the direct costs of the medicines.

Source: CECMED, Dr. Diadelis Remirez (http://www.cecmed.cu/content/guia-para-la-realizacion-de-estudios-farmacogenomicos-primera-en-la-region)

Workshop with regulators from EU, Japan and US open for registration

The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.

The workshop will take place at EMA’s premises in London on 21-22 June 2018.

It will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval.

Expressions of interest to attend the event should be sent to paediatric.antibacterial.agents.workshop@ema.europa.eu by 6 June 2018. Places are limited and will be allocated in a way that ensures a fair representation of all stakeholder groups and organisations.

The workshop will be broadcast live on the EMA website. An agenda of the event is available.

In light of the emergence of antimicrobial resistance as a major global public health threat, there is an urgent need to develop new medicines to treat infections caused by bacteria that have become resistant to most antibacterial agents currently available. Children are also affected by infections caused by these resistant bacteria and are equally in need of new therapeutic options. As paediatric development often takes several years after initial approval of medicines in adults, timely planning and conduct of fit-for-purpose paediatric studies is key to generate sufficient evidence to allow regulatory decisions and ultimately timely access to antibiotics for children who need them.

Highlights to be discussed at the workshop include:

• challenges with conducting trials in children;
• extrapolation of safety and efficacy data to optimise the involvement of children in clinical studies; and
• studies in newborn babies.

(…)

For more information go to http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/05/news_detail_002960.jsp&mid=WC0b01ac058004d5c1

[Original text in Spanish]

NEW LABORATORY OF MEDICAL DEVICES WILL INCREASE AT 74% ANALYZED UNITS

National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005

The National Institute for Food and Drug Surveillance (INVIMA) today inaugurated the new facilities of its laboratory for quality control of medical devices, which will allow the institution to analyze more than 18 thousand samples a year, an increase of 74 percent in relation to previous years.

This modern laboratory went from 33 m2 to 88 m2, which meant increasing its capacity to perform analyzes on medical devices such as: condoms, syringes, gloves, sutures, peripheral intravenous catheters, macrogoteo equipment, among others.

On the other hand, the National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005, in reference to latex male condom tests, sterile latex gloves, syringes and hypodermic needles

“As a health agency in the country we are proud to have an accredited laboratory, a pioneer in the Americas region in conducting quality control tests for Medical Devices and generators of research and innovation for the technical-scientific development that you need Colombia, “said Guzmán Cruz.

He also added that with the strengthening of human talent, infrastructure and acquisition of new equipment in 2018, the Medical Physical Devices Laboratory, will apply new technologies designed to meet the quality specifications of medical devices and will maintain the risk approach to evaluate the products with the greatest impact on the health of Colombians.

The challenge continues in the implementation of increasingly demanding projects, which position laboratories as a fundamental axis in the framework of the responsibility of health surveillance and in the issue of quality control, safety and efficiency of medical devices.

Source: https://www.invima.gov.co/nuevo-laboratorio-de-dispositivos-m%C3%A9dicos-aumentar%C3%A1-en-74-unidades-analizadas.html