WHO PUBLIC CONSULTATION: CALL FOR COMMENTS ON GUIDELINES FOR THE SAFE PRODUCTION AND QUALITY CONTROL OF POLIOMYELITIS VACCINE
The WHO Regulatory Standards for Vaccines and Biologicals unit opened a public consultation for regulators, manufacturers and other experts. The following document has been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for public comments:
- Guidelines for the safe production and quality control of poliomyelitis vaccine
http://www.who.int/biologicals/WHO_Safe_production_of_Polio_1st_PC_6_March_2018.pdf?ua=1
DEADLINE for submission of comments: 04 April 2018
Anvisa: Lots of the Sutent® cancer drug were counterfeit
By: Ascom / Anvisa
Posted: 03/03/2018 10:30
Last Modified: 03/03/2018 10:44
Pfizer Lab has identified 11 counterfeit lots that have not left its factory. Cancer drug is used in hospitals.
In a resolution published on Monday (5/3) in the Federal Official Gazette (DOU), Anvisa banned 11 falsified batches of the cancer drug Sutent® in the package with 28 50 mg capsules. Batches 746EE, 747EE, 748EE, 190EE, 045AA, 191EE, 189EE, 985EE, 986EE, 987EE and 749EE are falsified.
For more information go to: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4131460
REGULATORY AUTHORITIES OF THE PACIFIC ALLIANCE SIGN AGREEMENT TO IMPROVE THE REGISTRATION OF MEDICINES
• Colombia, Chile and Mexico advance on issues of pharmaceutical cooperation and reduce the gap in bioequivalence
• Within the framework of the meeting held in Medellin, Colombia, the regulatory authorities created a permanent technical team to consolidate harmonization and regulatory convergence
• Regional integration in regulatory matters responds to presidential mandates, has a long-term scope and clear benefits for the health of the population
In the framework of the meeting of the Inter-institutional Cooperation Agreement between Regulatory Authorities of the Pacific Alliance, which took place on March 1 and 2 in Medellín, Colombia, the authorities of Colombia, Chile and Mexico signed a commitment on Friday that will speed up the registration of medicines in the Region.
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For more information go to https://www.invima.gov.co/autoridades-sanitarias-de-la-alianza-del-pac%C3%ADfico-firman-compromiso-para-agilizar-el-registro-de-medicamentos.html
Canada: Revised versions of drug good manufacturing practices (GMP) documents are available
On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:
- Good manufacturing practices guide for drug products (GUI-0001),
- Risk classification guide for drug good manufacturing practices observations (GUI-0023),
- Good manufacturing practices for medical gases (GUI-0031), and
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119).
GUI-0001, GUI-0023, and GUI-0031 are revised versions of currently posted documents and GUI-0119 is a new document to replace the sterile products section of GUI-0001. These documents, except for GUI-0023, have an implementation date of October 1, 2018.
GUI-0023 will be implemented effective immediately as it will help you better understand how Health Canada currently assigns the risk rating to GMP inspection findings and the compliance rating for a GMP inspection. There are important changes in this guide as it relates to lower risk products and activities.
These documents have been updated to:
- address emerging issues such as increased reliance on foreign fabricators, packagers/labellers, and testers, and emerging trends such as data integrity,
- incoporate additional sample observations,
- help the medical gas industry comply with regulations,
- help industry comply with the regulations as they relate to sterile drugs, and
- be reformatted using plain language principles in accordance with new Canada.ca requirements, soon to be in effect.
Health Canada will host a series of webinars to review the revised guidance documents, highlight key changes and to answer any related questions. You can expect to receive invitations in the near future to attend webinars scheduled for:
- Thursday, March 29, 2018 on Good manufacturing practices for medical gases (GUI-0031), and
- May/June 2018 on the other three guidance documents (GUI-0001, GUI-0023, and GUI-0119).
Source: Health Product Inspection and Licensing Division
Falsificación en Nicaragua del producto Rocephin® (Ceftriaxona) 1000 mg, polvo para solución I.V
Información disponible en los siguientes sitios:
- Cuba: CECMED – COMUNICACIÓN DE RIESGO No. 01/2018.
El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Autoridad Reguladora Nacional de la República de Cuba, informa sobre la falsificación confirmada de Rocephin® (Ceftriaxona) 1000 mg, polvo para solución i.v en Nicaragua.
2. Ecuador: Arcsa alerta sobre lote falsificado de medicamento ROCEPHIN 1g INYECTABLE.La
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) da a conocer a la población ecuatoriana la alerta expuesta por la PAHO/WHO-OPS/OMS, sobre el comunicado realizado por la empresa Roche por falsificación del medicamento Rocephin® 1g (ceftriaxone), polvo para solución inyectable lote L.525.
6th ISoP–UMC Pharmacovigilance Training Course (Ecuador)
Save the date! Our 6th ISoP–UMC pharmacovigilance course takes place in Guayaquil, Ecuador in September, 24 – 26, 2018. More information will be made available and the registration will open soon.
If you have any questions please contact administration@isoponline.org.
Costa Rica: 120 Trasplantes de órganos se realizaron en el país en el 2017
26 de febrero 2018.
En el año 2017 en Costa Rica se realizaron 495 trasplantes, de estos, 120 trasplantes fueron de órganos, 297 de córneas y 78 trasplantes de médula ósea.
Más informaciones por el enlace https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2018/1280-120-trasplantes-de-organos-se-realizaron-en-el-pais-en-el-2017
Ecuador: Arcsa alerta sobre lote del producto CHAMPÚ COSVAL SALUD Y BELLEZA
Se trata del Lote X910915 del producto, que cuenta con Notificación Sanitaria Obligatoria colombiana No. INVIMA NSOC63380-14CO, del titular Comercio Cosval S.A.S y fabricado por Samara Cosmetics S.A.S.
Invima solicitó detener el uso del lote descrito, debido al resultado no conforme asociado con alteración de la calidad microbiológica, indicando a la comunidad en general que suspenda de inmediato su uso, debido a los riesgos que puede representar para su salud.
Ante esta información, Arcsa recomienda a la ciudadanía no comercializar, distribuir ni utilizar el producto “CHAMPÚ COSVAL SALUD Y BELLEZA”; cabe indicar que el producto no cuenta con la Notificación Sanitaria Obligatoria Ecuatoriana y por ello, al no poder garantizar su calidad, seguridad y eficacia, representa un riesgo para la salud de la población.
Arcsa invita a la ciudadanía a informar sobre la venta o distribución de productos sin Registro Sanitario y/o Notificación Sanitaria, o de dudosa procedencia, así como cualquier reacción adversa relacionada con algún producto de uso y consumo humano, a través del correo electrónico: farmaco.vigilancia@controlsanitario.gob.ec o mediante la aplicación “Arcsa Móvil”. Sus datos personales y la información brindada serán absolutamente confidenciales.
