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PIC/S NEWS
2026 PIC/S Seminar (Istanbul / Türkiye)
Geneva, 28 July 2026: Registrations for the 2026 PIC/S Seminar on “Digital Transformation in GMP” which will be hosted by Türkiye / TMMDA from 4-6 November 2026 are now open (for Medicines Regulatory Authorities only).…
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation: 26/07/2018, Revision: 10, Status: Authorised
Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation: 26/07/2018, Revision: 10, Status: Authorised
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MHRA (gov.uk) GUIDELINE
Ambient voice technology-enabled products
Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
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MHRA (gov.uk) NEWS
Beat the heat: MHRA urges people to take extra care with medical devices this summer
Simple steps to help keep your essential medical equipment working safely when temperatures rise.
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MHRA (gov.uk) NEWS
MHRA clarifies regulatory status of ambient voice technologies used in the NHS
The Medicines and Healthcare products Regulatory Agency has published guidance, developed in close partnership with NHS England, clarifying how existing medical device law applies to ambient voice technology (AVT)…
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US Federal Register – FDA (Rules/Notices/Guidance) LEGISLATION
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in this…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other…
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised
Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn
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PIC/S NEWS
United Arab Emirates applies for PIC/S Pre-Accession
Geneva, 28 July 2026: On 15 July 2026, a Rapporteur was appointed by written procedure for the pre-accession application of Emirates Drug Establishment (EDE), for which a pre-accession application was received on 5…
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PIC/S NEWS
Uzbekistan applies for PIC/S membership
Geneva, 28 July 2026: On 17 December 2025, the State Entity “Center of Good Practices” of the Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan and the State…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA),…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction
The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Federal Register on September 18, 2025. The notice established…
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised
Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised
Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised
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EMA – Scientific guidelines (human & veterinary) GUIDELINE
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 22, Status: Authorised
Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 22, Status: Authorised
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Apixaban Accord, apixaban, Date of authorisation: 23/07/2020, Revision: 8, Status: Authorised
Human medicines European public assessment report (EPAR): Apixaban Accord, apixaban, Date of authorisation: 23/07/2020, Revision: 8, Status: Authorised
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MHRA (gov.uk) REFERENCE
Bladder Anticholinergics: review of risk of dementia
Public Assessment Report on the safety review of the available data on the risk of dementia with the use of bladder anticholinergic medicines.
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act…
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Swissmedic NEWS
DHPC – Mounjaro KwikPen (tirzepatidum)
Notwendigkeit sachgemässe Verwendung
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MHRA (gov.uk) GUIDELINE
Safety Public Assessment Reports
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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MHRA (gov.uk) reference
AI Airlock Sandbox Phase 2 Programme Report
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
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EMA – New human medicines (EPAR) ASSESSMENT
Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Date of authorisation: 24/11/2011, Revision: 19, Status: Authorised
Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Date of authorisation: 24/11/2011, Revision: 19, Status: Authorised
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EMA – Regulatory & procedural guidelines GUIDELINE
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025