69 guidances, approvals and safety alerts affecting immunology, collected from official agency sources. Showing the 30 most recent.
Committee for Advanced Therapies (CAT) is scheduled to convene 7–9 October 2026 at the European Medicines Agency in Amsterdam to support the EU’s assessment…
CVMP is scheduled to meet on 6–8 October 2026 to prepare the European Medicines Agency’s opinions on veterinary medicines-related questions.
Launches WHO’s prequalification procedure for medical devices, signposting a new pathway for manufacturers to seek WHO endorsement and broader market access.
Announces the 2026 joint UNICEF/UNFPA/WHO meeting with manufacturers and suppliers (9–12 Nov 2026, hybrid, WHO Academy Lyon) focused on building resilient…
Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
Revision of the Swissmedic guidance for authorisation of biosimilars may refine the regulatory expectations for demonstrating biosimilarity, including how…
Requests RFQs from eligible European Notified Bodies to expand WHO’s technical assessment capacity for the WHO Prequalification Assessment of Medical Devices…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…
Provides a CHMP reflection framework for sponsors planning clinical development of medicinal products intended for systemic sclerosis, with particular emphasis…
Facilitates a structured dialogue between EMA and Affordable Medicines Europe to exchange views on topics of common interest within EMA’s annual bilateral…
Schedules EMA governance and stakeholder touchpoints (PDCO, CAT, CHMP) across early-to-mid September 2026, plus dedicated thematic sessions on paediatrics…
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…
Simplifies Swissmedic application procedures for changing a veterinary medicinal product’s status between its main authorisation and an export licence.
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…
Initiates a precautionary Class 2 recall of one batch of Fingolimod Zentiva 0.5 mg Capsules due to a potential risk of contamination with metal particles.
Clarifies FDA expectations for potency assessment strategies for active immunotherapy products, which may influence how sponsors design potency assays and…
Publishes new WHO Public Inspection Reports (WHOPIRs), expanding transparency on WHO-inspection outcomes for regulated product manufacturers.
Amends India’s Drugs and Cosmetics Rules, 2017 to incorporate EU countries within the scope of Rule 63 and extends/aligns Quality Management System (QMS)…
Publishes newly issued WHO Public Inspection Reports (WHOPIRs), which can affect how manufacturers prepare for and respond to WHO GMP-related inspections and…
Initiates a WHO public consultation on revisions to the Procedure for prequalification of vaccines, reflecting stakeholder experience and new regulatory…
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…
Establishes a forthcoming EMA CVMP guideline concept that will tighten quality and safety expectations for RNA interference (RNAi) and RNA antisense…
Defines EMA data expectations to support authorized equine influenza vaccine strain composition updates when aligned with WOAH Expert Surveillance Panel…
Revises EMA’s biosimilar guideline framework to reflect post-2015 scientific progress, including a tailored clinical approach for comparative efficacy studies…
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…
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