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.
234 mapped changes · 7 disciplines · 9 regulators
Information for health professionals about medicines with safety related updates to their Product Information.
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 ↗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.
PRESS RELEASE FOR IMMEDIATE RELEASE This new program is the first of its kind for organizations conducting IGG activities Frederick, Md (August 31, 2026)— The American Association for Laboratory Accreditation (A2LA), a global, nonprofit accreditation body, has launched an Investigative Genetic Genealogy (IGG) Accreditation Program, which assesses organizations that conduct IGG activities. This program is the […] The post A2LA Launches Investigative Genetic Genealogy (IGG) Accreditation Program appeared first on A2LA .
Más de cinco toneladas de detergentes para ropa de bebé, productos de higiene personal y cosméticos fueron incautados durante un operativo conjunto ejecutado por la Dirección General de Medicamentos, Insumos y Drogas (Digemid) del Ministerio de Salud (Minsa), el Ministerio Público y la División de Operaciones Especiales Escuadrón Verde de la Policía Nacional del Perú, en el distrito de San Juan de Miraflores.
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used.
Guidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.
La medida busca fortalecer la vigilancia sanitaria y garantizar una respuesta oportuna frente a productos falsificados, adulterados, de calidad subestándar y en mal estado de conservación.
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
20 August 2026 The South African Health Products Regulatory Authority (SAHPRA) wishes to remind healthcare professionals of the risk of angioedema during treatment with angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, quinapril, ramipril, trandolapril). Healthcare professionals are reminded that ACE inhibitor treatment should... The post Angiotensin-Converting Enzyme Inhibitor-Induced Angioedema: Risk of Serious and Fatal Outcomes appeared first on SAHPRA .
Read the SAHPRA record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) is informing the public of the circulation of a suspected counterfeit toothpaste product, ORACIRE+ TOOTHPASTE, which is being distributed in Nigeria under the guise of the registered ORACARE+ Toothpaste. This follows a formal complaint and a market intelligence report regarding the widespread distribution of […]
Read the NAFDAC record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs), and the general public of the seizure of a suspected Substandard and Falsified (SF) antimalarial medicine, Artemether/Lumefantrine 80mg/480mg, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India. The product was intercepted […]
Read the NAFDAC record ↗Have your say about the content and level of detection for ethylene oxide, propylene oxide and epichlorohydrin in end use products.
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals, importers, distributors, retailers, and the public that the Drug Regulatory Authority of Pakistan (DRAP) has recalled specific batches of adulterated and substandard medicines (Nitras, Kadin 2, Acefyl and Loratadine 24) due to quality defects, contamination concerns, and failure to meet […]
Read the NAFDAC record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) is informing healthcare professionals and the public of a report received concerning emerging evidence showing an increased risk of drug poisoning when gabapentinoids (gabapentin and pregabalin) are used together with certain medicines, particularly opioids and benzodiazepines. A study conducted by researchers at University College […]
We are seeking feedback on proposed changes to support automated decision making (ADM) for applications to change listed medicines.
DISPOSITIVO MÉDICO FALSIFICADO INCAUTADO EN ACCIONES DE CONTROL Y VIGILANCIA SANITARIA Productos: Mandil descartable Descargar
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
PRODUCTOS FARMACEUTICOS FALSIFICADOS INCAUTADOS EN ACCIONES DE CONTROL Y VIGILANCIA SANITARIA Productos: Dolocordralan Extra Forte
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
TGA is warning consumers against using Melanotan II tanning products.
El Ministerio de Salud (Minsa), a través de la Dirección General de Medicamentos, Insumos y Drogas (Digemid), desplegó una comisión de 24 inspectores especializados a la Argentina, Colombia e India. En estos países, la delegación evaluó el cumplimiento de los requisitos técnicos y sanitarios para la certificación de Buenas Prácticas de Manufactura (BPM) en 19 laboratorios farmacéuticos. Esta estrategia permite verificar las condiciones de origen de los fármacos que abastecen al país, al trasladar el control regulatorio hasta las plantas de fabricación en lugar de limitarlo al ingreso al territorio nacional.
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
Dapsone 50 mg tablets can be supplied and halved during the shortage.
Read the TGA record ↗Como parte de las acciones impulsadas por el ministro de Salud, Luis Dyer, se viene fortaleciendo la articulación con EsSalud para prevenir riesgos de desabastecimiento y contribuir a garantizar la continuidad de los tratamientos de pacientes que requieren medicamentos críticos.
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
RETIRO DEL MERCADO DE UN LOTE DE DISPOSITIVO MÉDICO OBSERVADO POR RESULTADO CRÍTICO DE CONTROL DE CALIDAD Productos: VCÁNULA NASAL DE OXÍGENO
Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
We would like your feedback on our proposal to improve information sharing about the safety, quality and performance of medical devices.
Guidance providing an overview of the legislative framework for listed medicines and assessed listed medicines.
The public Alert No. 042/2026, concerning the reported presence of whitish particulate matter in Deleject Disposable Needle Batch No. 240605, was uploaded onto the NAFDAC website in error. The matter had earlier undergone appropriate regulatory review and investigation and was satisfactorily resolved several months ago. There are currently no quality, safety, or regulatory issues that […]
The public Alert No. 042/2026, concerning the reported presence of whitish particulate matter in Deleject Disposable Needle Batch No. 240605, was uploaded onto the NAFDAC website in error. The matter had earlier undergone appropriate regulatory review and investigation and was satisfactorily resolved several months ago. There are currently no quality, safety, or regulatory issues that […]
This guidance is to assist sponsors in fulfilling the regulatory obligations necessary to ensure that any representations made about their listed medicine(s) comply with the requirements of the Therapeutic Goods Act 1989.
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare professionals, distributors, retailers, and the public of the presence of whitish particulate matter discovered on Deleject Disposable Needles, Batch No. 240605. NAFDAC received a consumer complaint regarding white particles in disposable needles. Samples of the affected product were submitted for laboratory […]
Information for health professionals about medicines with safety related updates to their Product Information.
Read the TGA record ↗Answers to the most frequently asked questions from conformity assessment bodies. Read more. Read More The post FAQs: ISO/IEC 17025:2017 Accreditation for Testing & Calibration Laboratories appeared first on A2LA .
Con el firme objetivo de llevar la regulación farmacéutica a un nivel superior, el ministro de Salud, Luis Dyer Fernández, lideró una visita clave a la Dirección General de Medicamentos, Insumos y Drogas (Digemid) para anunciar un plan para potenciar las capacidades técnicas y tecnológicas de la entidad, garantizar el acceso inmediato a medicamentos seguros, de calidad y a precios justos para todos los peruanos y una evaluación integral de las acciones adoptadas para erradicar definitivamente los fármacos falsificados del mercado nacional.
Read the DIGEMID record ↗Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas, Peru). Title reproduced verbatim in the original language.
We are reviewing new information that has raised concerns regarding the integrity and reliability of the clinical trial data that supported the approval of TAVNEOS (avacopan) in Australia.
Read the TGA record ↗We are seeking feedback on whether 11 international scientific guidelines should be adopted.
Geneva, 30 July 2026 PIC/S has published the revised PIC/S Recommendations on Qualification and Validation (PI 006-4). These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3). PI 006-4 will enter into force on 1 October 2026. To download the revised Recommendations document, please consult the page “Publications”.
Source: PIC/S (Pharmaceutical Inspection Co-operation Scheme). SPEQ links to the original and does not reproduce it.
Manufacturer Investigation Reports (MIRs) are critical documents used to assess complaints, adverse events, and product quality issues associated with medical devices and in vitro diagnostic (IVD) products. Effective handling of these reports ensures that potential risks to patients and users are promptly identified, investigated, and addressed. The process involves reviewing reported incidents, evaluating root causes, […]
The publisher issued this notice as a headline and link with no accompanying text. SPEQ has not summarised it; open the source for the full notice.
Read the EDQM record ↗Source: EDQM / Council of Europe. Ph. Eur. text is copyright EDQM; SPEQ characterises and links rather than reproducing.
To benefit from automation while maintaining compliance, it's critical that laboratories reassess traditional notions of competence, equipment validation, and data monitoring. Learn more. Read More The post ISO/IEC 17025 in the Age of Automation appeared first on A2LA .
We are seeking feedback on proposed changes to the Required Advisory Statements for Medicine Labels (RASML).
Con el propósito de fortalecer el cumplimiento de las Buenas Prácticas de Manufactura (BPM) y consolidar un sistema regulatorio cada vez más eficiente, el Ministerio de Salud (Minsa), a través de la Dirección General de Medicamentos, Insumos y Drogas (Digemid), realizó la Reunión Técnica "Buenas Prácticas de Manufactura para Laboratorios Nacionales 2026", dirigida a los laboratorios fabricantes de productos farmacéuticos, dispositivos médicos y productos sanitarios del país.
Source: DIGEMID (Peru). Title reproduced verbatim in the original language.
This Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
Guidance about how to advertise therapeutic goods exclusively to health professionals.
Information for health professionals about medicines with safety related updates to their Product Information.
Read the TGA record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the marketing and sale of unregistered Menofix Composition. NAFDAC received a complaint concerning the marketing and sale of Menofix Capsules. The complainant also raised concerns regarding possible liver-related adverse effects associated with some of the ingredients contained in the […]
The National Agency for Food and Drug Administration and Control (NAFDAC) is informing the public of the detection of suspected counterfeit medicinal products found in the Nigerian market that infringe on the approved marketing authorization of Forxiga® (dapagliflozin) manufactured by AstraZeneca. AstraZeneca notified NAFDAC following market surveillance activities which identified products bearing names closely resembling […]
Read the NAFDAC record ↗The National Agency for Food and Drug Administration and Control (NAFDAC) is informing the public of the detection of a suspected counterfeit medicinal product found in the Nigerian market that infringes on the approved marketing authorization of Pulmicort® (Budesonide) manufactured by AstraZeneca. The information was provided to NAFDAC by AstraZeneca following market surveillance activities. AstraZeneca […]
Read the NAFDAC record ↗Geneva, 16 July 2026: The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide. This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management. This concept paper was submitted to a joint EMA - PIC/S public consultation and comments have been collected until 9 April 2026. Following the public consultation, the initial timetable has been revised, and only this section has been updated accordingly. The revised Concept Paper can be downloaded on the PIC/S website (link), as well as on the EMA website (link).
Source: PIC/S (Pharmaceutical Inspection Co-operation Scheme). SPEQ links to the original and does not reproduce it.
This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Niger Republic’s Ministry of Trade and Industry has banned the importation of Bulmex Parboiled Rice from India. The action was reportedly taken due to concerns raised during an investigation and regulatory oversight by the Agadez Regional Directorate of Commerce […]
TGA reviewed the TouchBio Chlamydia & Gonorrhoea self-test (for females) to verify its performance.
We are advising consumers that sexual enhancement products labelled as ‘honey’ may pose a serious risk to your health and should not be taken.
Read the TGA record ↗Cases of liver injury associated with herbal preparations containing Withania somnifera, commonly known as Ashwagandha, continue to be reported both in Australia and internationally.
Read the TGA record ↗For medical device and pharmaceutical manufacturers, packaging is a critical part of product performance and regulatory compliance. Read more. Read More The post Accreditation Case Study: DDL, Inc. appeared first on A2LA .
We are advising that Eagle Research Lab branded selective androgen receptor modulators (SARMs) pose a serious risk to your health and should not be taken.
We are seeking feedback on proposed changes to improve the Therapeutic Goods Advertising Code.
The publisher issued this notice as a headline and link with no accompanying text. SPEQ has not summarised it; open the source for the full notice.
Read the EDQM record ↗Source: EDQM / Council of Europe. Ph. Eur. text is copyright EDQM; SPEQ characterises and links rather than reproducing.
Learn how to determine whether your product is a cosmetic or therapeutic good and understand the regulatory and advertising requirements that apply.
We are advising consumers that ITCHA SSS capsules, marketed for weight management, have been found to contain oxedrine, an undisclosed prescription-only medicine.
Guidance on regulatory requirements for Ahpra-registered dental practitioners making and adapting personalised medical devices for patients.
Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods.
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.