59 guidances, approvals and safety alerts affecting respiratory, 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.
Scientific advisory structure for vaping products under Health Canada is highlighted, indicating ongoing expert input that may shape future regulatory…
Expands WHO in vitro diagnostics (IVD) prequalification scope effective 1 September 2026 to include Interferon-Gamma Release Assays (IGRAs) for tuberculosis…
Expands WHO IVD prequalification scope to include Interferon-Gamma Release Assays (IGRAs) and targeted Next-Generation Sequencing (tNGS) assays for…
Launches WHO’s prequalification procedure for medical devices, signposting a new pathway for manufacturers to seek WHO endorsement and broader market access.
Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…
Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…
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…
Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of…
Amends India’s Drugs Rules, 1945 Schedule K to incorporate levonorgestrel emergency contraceptive tablets (0.75 mg and 1.5 mg) into the specified regulatory…
Simplifies Swissmedic application procedures for changing a veterinary medicinal product’s status between its main authorisation and an export licence.
Withdrawal from the UK market of the NGPod handheld pH testing device (NGPod handheld device and NGPod sensor) because the manufacturer has ceased trading in…
Introduces a draft amendment notice for Korea’s MFDS regulations on the safety of pharmaceuticals and related products.
Clarifies FDA expectations for demonstrating therapeutic equivalence for approved drug products, with emphasis on the evidentiary basis used to support…
Prohibits all fixed-dose combination (FDC) formulations containing chlorpheniramine maleate and phenylephrine HCl from being used in children below four years…
National Patient Safety Alert highlights a safety risk for ResMed Astral 100 and 150 ventilators (and associated Printed Circuit Board Assembly spare parts)…
Publishes new WHO WHOPARs (Public Assessment Reports) for multiple in vitro diagnostic (IVD) products, including Aptima HPV assays (genotype and pooled), cobas…
Sets out an EMA online meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, created under Regulation (EU) 2022/123 to strengthen…
Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO, indicating a move toward more harmonized and predictable assessment…
Common Submission Format guidance for importing and registering drugs (bulk and finished formulations) in India is intended to standardize how dossiers are…
Defines EMA data expectations to support authorized equine influenza vaccine strain composition updates when aligned with WOAH Expert Surveillance Panel…
Clarifies and expands the EMA/CVMP guidance for evaluating pharmaceutical fixed combination veterinary medicinal products, aiming to improve consistency of…
Prohibits the marketing/approval of 16 fixed-dose combinations (FDCs) under specified Gazette notifications, potentially affecting existing and pending…
Highlights the 20-year evolution of EMA’s Patients’ and Consumers’ Working Party (PCWP) from a patient organisations working group (2003) to an EMA-endorsed…
Updates EMA clinical evaluation expectations for antifungal agents to better support regulatory claims for treatment/prophylaxis of invasive fungal disease…
Outlines a draft master protocol framework for coordinating and managing multiple clinical studies supporting drug and biological product development…
Simplifies the process for obtaining test licences for the import of drugs under Form 11 of the Drugs Rules, 1945, which may reduce administrative burden and…
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