53 guidances, approvals and safety alerts affecting gastroenterology, 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.
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…
Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…
Provides updated EMA recommendations for investigating and interpreting gastrointestinal absorption-related drug interactions driven by extrinsic factors such…
Facilitates a structured dialogue between EMA and Affordable Medicines Europe to exchange views on topics of common interest within EMA’s annual bilateral…
Establishes temporary FDA policy for compounding certain starter parenteral nutrition products intended for neonates, aiming to maintain supply while…
Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of…
Clarifies how pharmacokinetic studies in patients with impaired hepatic function should be designed and analyzed to support labeling recommendations, with an…
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…
Rectal gas and colic reliever catheters sold for personal use are not to be used in infants for any indication, including colic, gas-related discomfort, or…
Common Submission Format guidance for importing and registering drugs (bulk and finished formulations) in India is intended to standardize how dossiers are…
Prohibits the marketing/approval of 16 fixed-dose combinations (FDCs) under specified Gazette notifications, potentially affecting existing and pending…
Product-specific bioequivalence (BE) guidance for semaglutide pre-filled pen products specifies how to demonstrate PK equivalence across multiple strengths and…
Launches a legislative notice proposing partial amendments to Korea’s Food Sanitation Act Enforcement Decree and Enforcement Rules.
Updates WHO’s Expression of Interest (EOI) process for manufacturers seeking WHO Prequalification Unit product evaluation for medicines used in diabetes…
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…
Strengthens CDSCO enforcement posture against the unauthorized promotion and distribution of GLP-1 based drugs, indicating tighter scrutiny of marketing claims…
Class 4 defect notification addressed to Milpharm Limited highlights a discrepancy in the previously approved Patient Information Leaflet (PIL) for loperamide…
Committee for Herbal Medicinal Products (HMPC) meeting 4–6 May 2026 will compile and publish HMPC opinions and related outputs for questions on herbal…
Initiates a Class 3 recall of specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing required information in the Patient Information…
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