FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.
For more information go to https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm610279.htm
RESERVE A DATA: IX Conferência Pan-Americana para a Harmonização da Regulamentação Farmacêutica (CPARF)
Este ano, a IX CPARF será realizada em San Salvador, El Salvador, de 24 a 26 de outubro, nas dependências do Hotel Sheraton Presidente, localizado na Avenida De La Revolución, em San Salvador, El Salvador.
O Programa está em desenvolvimento e será divulgado em breve.
Jamaica: 9th Annual National Health Research Conference
The Ministry of Health will be hosting its 9th Annual National Health Research Conference in November.
Research being conducted in four (4) main areas: (i) Oral Health (ii) Intentional and Unintentional Injuries (iii) Non-communicable Diseases, featuring cancers and (iv) Family Planning, will be showcased.
For more information go to :
Ministry of Health 9th Annual National Health Research Conference Call for Abstracts
FDA: Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application
This guidance describes FDA’s enforcement approach with respect to over-the-counter (OTC) sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC sunscreen drug products without an approved application. OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are generally recognized as safe and effective (GRASE) and not misbranded. However, OTC sunscreens marketed without approved applications and containing specified active ingredients (see section II., Background) are subject to labeling and testing requirements located at 21 CFR 201.327. Several other ongoing and planned rulemaking proceedings will also address these products.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
For more information go to https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf
Canada: Regulation of non-prescription drugs
Find out how non-prescription drugs are regulated and licensed.
Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription.
Canada regulates non-prescription drugs to:
- make sure they’re safe to use
- reduce health risks to Canadians
For more information go to https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs.html#s1
Ecuador: Arcsa controla laboratorios de productos naturales en Ambato
Técnicos de la Coordinación Zonal 3 de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) visitaron laboratorios de productos naturales de Ambato, con el objetivo de verificar las condiciones higiénico-sanitarias, almacenamiento y procesos de producción empleados para la elaboración de este tipo de productos que son distribuidos a nivel nacional.
“Este tipo de inspecciones se las realiza de manera permanente en toda la zona con el fin de brindar recomendaciones de mejora en la elaboración de productos naturales y suplementos alimenticios, para precautelar la salud de la población que los consume”, dijo Carlos Barreno, técnico de la Coordinación Zonal 3 de Arcsa.
Como parte del control, se verificó que los productos cumplan con el etiquetado aprobado en el Registro Sanitario, así como con la normativa sanitaria vigente, para evitar posibles casos de publicidad engañosa y confusión en las propiedades alimenticias y terapéuticas de dichos productos.
De acuerdo con la Resolución ARCSA-DE-008-2018-JCGO sobre Buenas Prácticas de Manufactura para Laboratorios Farmacéuticos: “Los laboratorios farmacéuticos nacionales de medicamentos en general que adicionalmente fabriquen productos naturales procesados de uso medicinal, deben fabricar estos productos bajo la modalidad de campaña o de preferencia en áreas autónomas e independientes, cumpliendo con Buenas Prácticas de Manufactura respectivas para cada tipo de producto”.
Arcsa motiva a laboratorios de productos naturales y suplementos alimenticios a cumplir con la normativa sanitaria vigente, para evitar posibles procesos sancionatorios y perjuicios en la salud de los consumidores.
Fuente: https://www.controlsanitario.gob.ec/arcsa-controla-laboratorios-de-productos-naturales-en-ambato/
México: Segundo Simposio de cannabis medicinal para profesionales de la salud
El Comisionado para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, inauguró hoy el “Segundo Simposio de cannabis medicinal para profesionales de la salud”, organizado por la Directora de CannabiSalud, Lorena Beltrán.
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Dia Mundial do Doador de Sangue 2018
No dia 14 de junho de cada ano, o Dia Mundial do Dador de Sangue é celebrado para agradecer aos voluntários doadores não remunerados e aumentar a conscientização sobre a necessidade de fazer doações regulares para garantir a qualidade, segurança e disponibilidade de sangue e seus produtos.
Mais informações pelo link https://www.paho.org/hq/index.php?option=com_content&view=article&id=14307%3Aworld-blood-donor-day-2018&catid=8699%3Awbdd&Itemid=72270&lang=es
México: La COFEPRIS y la Federación Nacional de Medicina Tradicional y Herbolaria, firman convenio de colaboración
La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) y la Federación Nacional de la Industria Herbolaria, Medicina Alternativa Tradicional y Naturista A.C. (FNIHMATN), firmaron hoy un convenio de colaboración que tiene como objetivo principal establecer las acciones necesarias para contar con la regulación sanitaria que norme a los productos y plantas utilizadas por este sector así como mejorar y actualizar los procesos técnicos y de capacitación continua.