[ WHAT CHANGED ]
Machine-detected, mapped, source-linked. Every item below is mapped to what it touches — the standards, the disciplines, the sectors — and to the artefact that closes it. Only changes that map to something publish.
428 mapped changes · 8 disciplines · 17 regulators
We are seeking feedback on whether the current exclusion for certain digital mental health tools (DMHTs) DMHTs should be kept, removed or modified.
Retail-level recall of one batch of DANTRIUM 20 mg Powder for Solution for Injection, containing dantrolene, due to presence of visible foreign particulate matter in the vials.
ISO/IEC 17020 provides a framework for fire investigators to ensure competence, impartiality, and consistency throughout the investigation process. Learn more. Read More The post Why ISO/IEC 17020 Matters in Fire Investigations appeared first on A2LA .
Read the A2LA record ↗Medtronic está realizando una recolección del producto por un posible exceso de material en lotes específicos. Durante el proceso de fabricación, se identificó material suelto inesperado en el luer masculino utilizado en la AORTIC ROOT CANNULAE (cánula de raíz aórtica). Los daños potenciales cuando se identifican antes del uso son la demora del procedimiento mientras se localiza otra cánula. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DM20929E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Intuitive Surgical INC. ha emitido como medida preventiva un AVISO DE SEGURIDAD EN CAMPO (FSCA), debido a un incremento en los reclamos relacionados con cables deshilachados o rotos en algunos instrumentos reutilizables da Vinci X y Xi, ya que estos cables forman parte del mecanismo que controla la apertura y cierre de la pinza del instrumento. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DM25937E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Merit Medical Systems, Inc. ha emitido una comunicación de AVISO VOLUNTARIO DE SEGURIDAD DEL DISPOSITIVO, para el producto BASIX COMPAK™ INFLATION DEVICE. El fabricante emite este aviso de seguridad de manera preventiva, dando indicaciones en caso suceda el desprendimiento del mango de la jeringa durante el uso, debido a una cantidad insuficiente de adhesivo. Este dispositivo médico se encuentra registrado con R.S. N° DM22695E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
BD Switzerland Sarl ha emitido una comunicación de ACCIÓN DE SEGURIDAD EN CAMPO (FSCA) debido a que el fabricante a identificado que las bombas de jeringa pueden desarrollar alguna anomalía mecánica en el potenciómetro lineal si el dispositivo no se almacena en la posición correcta. Por ello, se procederá a comunicar las instrucciones de uso y actualizar el Manual Técnico. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DB5394E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
ERBE ELEKTROMEDIZIN GMBH ha emitido una ACCIÓN DE SEGURIDAD EN CAMPO (FSCA) para lotes particulares del dispositivo médico Criosondas Flexibles, debido al riesgo de ruptura o estallido del tubo externo durante su activación. El fabricante comunico el retiro voluntario de lotes particulares. Este dispositivo médico se encuentra registrado en el Peru con R.S. N° DM28049E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
BOSTON SCIENTIFIC CORPORATION como fabricante de los Marcapasos cardiacos implantables ACCOLADE™, procede con la acción de campo relacionada con la actualización del software con la finalidad de optimizar el desempeño del dispositivo mitigando el riesgo en condiciones asociadas de alta impedancia de la batería. Este dispositivo médico se encuentra registrado en el Perú con R.S. N° DM10672E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Becton Dickinson del Uruguay, S.A. Sucursal Perú ha emitido una comunicación de RETIRO VOLUNTARIO para el producto Alaris™ VP Infusion Sets debido a que presentan un potencial fuga de fluido desde el tubo de silicona al final del segmento de bombeo. Este dispositivo médico se encuentra registrado con R.S. N° DM17860E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
GE HealthCare ha emitido una comunicación de ACCIÓN DE SEGURIDAD EN CAMPO (FSCA) debido al apagado inesperado de los sistemas de anestesia Carestation de las series 600 y 700. GE HealthCare indica puede seguir utilizando la máquina de anestesia afectada con tarjeta de gestión de energía siguiendo las nuevas instrucciones. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DB6415E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Maquet Cardiopulmonary GmbH (MCP) ha emitido un Aviso Urgente de Seguridad en Campo para el producto CARDIOHELP SYSTEM, debido a información incorrecta sobre la configuración de fábrica en las Instrucciones de uso (IFU). El fabricante procederá a reemplazar las instrucciones de uso incorrectas. Este dispositivo médico se encuentra registrado en el Perú con R.S. N° DB3726E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Merit Medical Systems, Inc. (Merit) está retirando voluntariamente del mercado el Introductor de Vaina Divisible con Doble Válvula 16F de Merit debido a un defecto de diseño. Es posible que el introductor no se divida como está previsto. Si el introductor de vaina no se divide como está previsto, puede producirse hemorragia, cuerpos extraños y retrasos en el procedimiento. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DM18731E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026.
MEDTRONIC MINIMED está informando una acción de seguridad de campo referente a la actualización del software de su producto, debido a que identificó dos problemas que causaban que los datos que se mostraban en el gráfico de resumen de glucosa del sensor de 24 horas dentro de CareLink™ Clinic fueran incorrectos. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DB6676E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
HOLOGIC INC proporciono una acción correctiva de campo, en el consistente en un kit de accesorios diseñado para asegurar el funcionamiento adecuado del dispositivo medico HORIZON W. Durante las pruebas de cumplimiento estándar. HOLOGIC identificó un incumplimiento en los dispositivos HORIZON DXA, el incumplimiento se refiere a los requisitos de compatibilidad electromagnética. En el Perú este dispositivo médico se encuentra registrado con R.S. N° DBC0741E
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
From July 1 to September 30, 2026, Health Canada approved 16 new drug submissions (14 pharmaceuticals, 2 biologics) and 540 new medical devices, including 27 Class IV medical devices, which present the greatest potential risk. During this period, Health Canada also approved 30 generic drugs and 3 biosimilar drugs.
Canadians expect timely access to safe and effective drugs and medical devices. Health Canada is providing a quarterly update on the steps the department is taking to make its regulatory processes more modern and efficient, while maintaining high standards for safety, efficacy, and quality.
FDA final guidance on reporting categories and comparability data for manufacturing changes to licensed biosimilar and interchangeable biosimilar products.
The Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate and pyridoxal 5-phosphate monohydrate.
The National Agency for Food and Drug Administration and Control (NAFDAC) reaffirmed its commitment to strengthening the regulation of pesticides in Nigeria, curbing the circulation of banned, unregistered and falsified pesticide products, and protecting public health, food safety and the integrity of the nation’s agricultural value chain. NAFDAC’s stronger focus on pesticide control recognizes that […]
Read the NAFDAC record ↗DHPC type: Adverse event; Post-authorisation measure. Active substances: ocrelizumab. Regulatory outcome: Variation. Therapeutic area: Multiple Sclerosis. Disseminated: 2026-10-08.
Read the EMA record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) reaffirmed its commitment to strengthening the regulation of pesticides in Nigeria, curbing the circulation of banned, unregistered and falsified pesticide products, and protecting public health, food safety and the integrity of the nation’s agricultural value chain. NAFDAC’s stronger focus on pesticide control recognizes that […]
Read the NAFDAC record ↗This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.
Consumers are advised that the medicines listed below containing Andrographis paniculata (Andrographis) are being recalled due to the risk of severe allergic reactions.
Read the TGA record ↗We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 7 listed medicines.
HSA organised a zoom webinar on Concurrent Change Notification and Premarket Submission Checklist for Medical Device Product Registration on 24 September 2026.
New medicine labelling standards have been published to replace TGO 91 and TGO 92. Sponsors will have a 5-year transition period to update labels.
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
Read the FDA record ↗Strengthen Spreadsheet Controls. Reduce Compliance Risk. Spreadsheets remain one of the most widely used tools across pharmaceutical operations, supporting everything from laboratory calculations and stability programs to equipment maintenance, quality systems, and product release decisions. […] The post Data Integrity Guide: Spreadsheet Validation appeared first on Rx-360 - The International Pharmaceutical Supply Chain Consortium .
Read the Rx-360 record ↗This guidance is for journalists and news organisations and explains when news reports about therapeutic goods may be regulated as advertising.
Geneva, 23 September 2026:The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include the revised Annex 19 (Reference and Retention Samples).The revision of PIC/S Annex 19 primarily concerns Section 9, which addresses reference and retention samples for parallel imported, parallel distributed, and parallel traded products. The note clarifying that Section 9 applies only where local legislation covers parallel imported, parallel distributed, or parallel traded products — present in the previous version of the PIC/S GMP Guide (PE 009-17) — has been retained in the current version (PE 009-18).This update aligns with the Co-operation Agreement between PIC/S and the EMA, which mandates the harmonisation of PIC/S and EU GMP Guides. The aim is to maintain equivalent GMP standards, thereby facilitating the exchange and use of information concerning the manufacture of medicinal products, in line with PIC/S' mission to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems for inspectorates in the field of medicinal products.The revised Annex 19 was successfully adopted by the PIC/S Committee by written procedure on 22 September 2026. The revised GMP Guide (PE 009-18), with the revised Annex 19 will enter into force on 24 September 2026. This coincides with the entry into force of the revised Annex 19 in the EU following the publication by the European Commission of the revised Annex 19 on Eudralex Volume 4 on 23 June 2026.All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annex 19 of the PIC/S GMP Guide into their own GMP Guides.To download the revised GMP Guide (PE 009-18), please consult the “Publications” page.
Source: PIC/S (Pharmaceutical Inspection Co-operation Scheme). SPEQ links to the original and does not reproduce it.
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
The event included a formal presentation from Trace McInturff, A2LA Vice President of Accreditation Services, highlighting A2LA’s growth, strategic vision, and investment in supporting laboratories, inspection bodies, product certification bodies, proficiency testing providers, and more. Read More The post A2LA Presents Expanded Service Capabilities Supporting Accreditation Industry at Boulder Office Open House appeared first on A2LA .
Read the A2LA record ↗Status: Shortage ongoing. Active substance or common name: human normal immunoglobulins. Pharmaceutical forms affected: Solution for injection/infusion. Alternatives available: Yes. Expected resolution: March 2027. Therapeutic area: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes.
Read the EMA record ↗The MHRA and the Regulatory Innovation Office (RIO) invite organisations to share their views on the use of artificial intelligence (AI) in medicines development.
Andrographis paniculata (Andrographis) has been removed from the ingredients allowed in new listed medicines intended for supply in Australia from 17 September 2026.
Status: Shortage resolved. Active substance or common name: concentrate of proteolytic enzymes enriched in bromelain. Alternatives available: No. Therapeutic area: Debridement.
Read the EMA record ↗We have decided to remove Andrographis paniculata from the Permissible Ingredients Determination following an updated safety review and supplementary report and consideration of submissions received through a targeted consultation.
Status: Shortage resolved. Active substance or common name: parecoxib. Pharmaceutical forms affected: Powder and solvent for solution for injection; Powder for solution for injection. Strengths affected: 40 mg.
Read the EMA record ↗The Transactions Haven’t Changed. The Network Has. Flying home from the HDA Traceability Seminar last week, I saw some news from Philadelphia that put much of what we had spent the previous few days discussing […] The post The Next Episode | What 13 Years of DSCSA Teach Us About NDC-12 and Pharmaceutical Interoperability appeared first on Rx-360 - The International Pharmaceutical Supply Chain Consortium .
Read the Rx-360 record ↗This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
Retatrutide products marketed for weight loss may pose a serious risk to your health and should not be used.
Information for health professionals about medicines with safety related updates to their Product Information.
Read the TGA record ↗Con el objetivo de garantizar un abastecimiento eficiente y oportuno de medicinas a nivel nacional, el Ministerio de Salud (Minsa), a través de la Dirección General de Medicamentos, Insumos y Drogas (Digemid), implementó la versión 2.6 del SISMED. Esta nueva herramienta tecnológica optimiza la planificación de los recursos mediante información en línea y trazable. Con este cambio, el sistema de salud migra de un control de stock estático a una gestión predictiva que evalúa la disponibilidad, mide la demanda insatisfecha y anticipa las necesidades reales de medicamentos en los establecimientos de salud del país.
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
Have your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Chemicals Scheduling (ACCS).
Have your say about proposals to amend the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC). These will be considered at the next meeting of the joint meeting of Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS).
Have your say about proposals to amend the Poisons Standard in relation to nitrous oxide. These will be considered at the next meeting of the joint meeting of Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS).
Aidacare Pty Ltd has updated the user manual for the Aspire Active Air 8 Pressure Care Mattress to add setup instructions and warnings about using the device in the presence of oxygen enriched environments.
Read the TGA record ↗The National Agency for Food and Drug Administration and Control (NAFDAC), in collaboration with the National Health Research Ethics Committee (NHREC), announces new dates for the NAFDAC Mandatory Stakeholders Training on Clinical Trial Regulations in Nigeria. The training was earlier postponed from its originally announced maiden date; it will now hold from Monday, 5th October […]
Read the NAFDAC record ↗Status: Shortage ongoing. Active substance or common name: albendazole. Pharmaceutical forms affected: Tablet; Suspension. Alternatives available: Yes. Expected resolution: 2028. Therapeutic area: Parasitic Diseases; Protozoan Infections; Helminthiasis.
Read the EMA record ↗Status: Medicine discontinued. Active substance or common name: parathyroid hormone. Pharmaceutical forms affected: Powder and solvent for solution for injection. Strengths affected: 100 micrograms/dose; 75 micrograms/dose; 50 micrograms/dose; 25 micrograms/dose. Alternatives available: Yes. Therapeutic area: Hypoparathyroidism.
Read the EMA record ↗Updated classification rules for non-invasive medical devices that are used to maintain the patency or flush the lumen of another medical device.
Status: Shortage ongoing. Active substance or common name: verteporfin. Pharmaceutical forms affected: Powder for solution for infusion. Strengths affected: 15 mg. Alternatives available: Yes. Shortage started: 2020-05-01. Expected resolution: 2027. Therapeutic area: Myopia, Degenerative; Macular Degeneration.
Read the EMA record ↗Status: Shortage resolved. Active substance or common name: liraglutide. Pharmaceutical forms affected: Solution for injection in pre-filled pen. Strengths affected: 6 mg/ml. Therapeutic area: Obesity; Overweight.
Read the EMA record ↗ICH and ISoP have signed a Memorandum of Understanding to formalise their strategic collaboration to strengthen global awareness, recognition and adoption of ICH Guidelines, with a focus on pharmacovigilance, medication safety and MedDRA, a standardised international medical terminology produced by ICH.
Status: Shortage ongoing. Active substance or common name: esmolol. Pharmaceutical forms affected: Solution for intravenous injection. Strengths affected: 10 mg/ml. Alternatives available: Yes. Expected resolution: End of 2027. Therapeutic area: Tachycardia, Supraventricular; Hypertension.
Read the EMA record ↗Guidance applies to self-tests and point-of-care combo test kits.
Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
SPEQ is not affiliated with any regulator. Each item links to the primary source; where a source carries a copyright constraint SPEQ characterises it and links rather than reproducing it. The mapping is SPEQ’s; the record is the regulator’s.