132 guidances, approvals and safety alerts affecting infectious_disease, collected from official agency sources. Showing the 30 most recent.
CVMP is scheduled to meet on 6–8 October 2026 to prepare the European Medicines Agency’s opinions on veterinary medicines-related questions.
Expands access to WHO Emergency Use Listing diagnostics by listing the Xpert® Hemorrhagic Fever Panel under the WHO Emergency Use List for Bundibugyo virus…
Review of the federal approach to pandemic science advice and research coordination suggests an evolution of how expert advisory input is generated…
Expands WHO in vitro diagnostics (IVD) prequalification scope effective 1 September 2026 to include Interferon-Gamma Release Assays (IGRAs) for tuberculosis…
Expands WHO medical device prequalification to include additional life-saving device categories, specifically contraceptives and innovative tuberculosis (TB)…
Expands WHO IVD prequalification scope to include Interferon-Gamma Release Assays (IGRAs) and targeted Next-Generation Sequencing (tNGS) assays for…
WHO prequalification has been granted for bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited, supporting its availability as a…
Launches WHO’s prequalification procedure for medical devices, signposting a new pathway for manufacturers to seek WHO endorsement and broader market access.
Adds the DiaCarta Inc. QuantiVirus MPXV Test Kit to WHO’s Emergency Use Listing (EUL) for mpox diagnostics, enabling countries and procurers to source…
Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…
Announces the 2026 joint UNICEF/UNFPA/WHO meeting with manufacturers and suppliers (9–12 Nov 2026, hybrid, WHO Academy Lyon) focused on building resilient…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
Adds QCIL’s artemether/lumefantrine 20 mg/120 mg tablet (MA211) to the WHO Prequalification list, supporting availability of a quality-assessed ACT from…
Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product…
WHO prequalification has been granted for pyrazinamide manufactured by Resonance Specialities Limited under the WHO API prequalification procedure, enabling…
Adds three pediatric primaquine (as phosphate) tablet strengths by Ipca, India to the WHO Prequalification Unit (PQT) prequalified list for prevention of…
WHO prequalifies Lamivudine API manufactured by Jiangxi Desano Pharmaceutical Co. Ltd., enabling manufacturers of finished pharmaceutical products (FPPs) for…
Requests RFQs from eligible European Notified Bodies to expand WHO’s technical assessment capacity for the WHO Prequalification Assessment of Medical Devices…
Updates between 20 June and 21 July 2026 revised multiple WHO Public Assessment Reports (WHOPAR) for in vitro diagnostics to reflect changes in product…
Notification of a Class 4 defect relating to errors in the Patient Information Leaflet (PIL) for certain batches of meropenem 1000 mg powder and solvent for…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…
Indiscriminate use of NSAIDs and antibiotics is being highlighted as a safety concern linked to increased risk of Chronic Kidney Disease (CKD), implying the…
Clarifies and strengthens SPC (product information) expectations for veterinary antimicrobial products by explicitly tying prophylaxis and metaphylaxis…
Adds the first Bundibugyo virus (BDBV) molecular diagnostic test to WHO’s Emergency Use Listing (EUL), enabling rapid identification of BDBV infection by…
Adds the Determine™ Syphilis Advanced point-of-care immunoassay to WHO’s list of prequalified IVDs for qualitative detection of Treponema pallidum antibodies…
Prequalifies ritonavir API from Qidong Dongyue Pharmaceutical Co., Ltd under WHO’s API prequalification procedure to support access to quality HIV/AIDS…
Facilitates a structured dialogue between EMA and Affordable Medicines Europe to exchange views on topics of common interest within EMA’s annual bilateral…
Schedules the CVMP meeting for 8–10 September 2026, enabling stakeholders to track committee deliberations and expected scientific opinions or guidance-related…
Prohibits the manufacture, import, sale, and distribution of carboxypenicillins and phosphonic acid derivatives intended for animal use, signaling a…
Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of…
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