61 guidances, approvals and safety alerts affecting neurology, 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.
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…
Class 4 medicines defect notification submitted by Neuraxpharm UK Limited indicates that a review of the approved Patient Information Leaflet (PIL) has…
Requests RFQs from eligible European Notified Bodies to expand WHO’s technical assessment capacity for the WHO Prequalification Assessment of Medical Devices…
Promotes structured collaboration to address gaps in real-world data (RWD) collection for Duchenne muscular dystrophy, with the goal of generating meaningful…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…
Reports a Class 4 medicines defect notification to the MHRA concerning an error with the linear barcode for certain batches of Clobazam Martindale Pharma 5…
Facilitates a structured dialogue between EMA and Affordable Medicines Europe to exchange views on topics of common interest within EMA’s annual bilateral…
Sets out EMA expectations for the clinical investigation strategy and pivotal trial methodology for medicinal products intended for acute and prophylactic…
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.
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…
Prohibits the marketing/approval of 16 fixed-dose combinations (FDCs) under specified Gazette notifications, potentially affecting existing and pending…
Outlines FDA’s key considerations for designing, conducting, and monitoring clinical investigations involving psychedelic drugs, with an emphasis on patient…
Triggers a MHRA defect notification for a gabapentin oral solution due to customer-reported particles observed in some bottles, indicating a potential quality…
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…
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…
Plans the next CHMP meeting session (22–25 June 2026) at the European Medicines Agency in Amsterdam, where CHMP will prepare agency opinions on matters…
Draft CDSCO notification rationalizes how shelf life is set under Rule 31 of the Drugs Rules, 1945, potentially changing the expectations for stability…
Defines expectations for the SEND (Standard for Exchange of Nonclinical Data) datasets to be submitted with new authorisation applications for human medicinal…
Discusses how FDA may consider and leverage prior knowledge when developing human gene therapy products that incorporate genome editing, potentially…
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