44 guidances, approvals and safety alerts affecting hematology, 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…
Expands the WHO API prequalification Expression of Interest (EOI) process to include additional APIs—Hydrocortisone (sodium succinate), Dactinomycin…
Launches the first WHO PQT invitation for manufacturers to submit an Expression of Interest (EOI) for evaluation of hydroxyurea products for the treatment of…
Adds hydroxyurea API for products used to treat sickle cell disease to the WHO Prequalification Unit (PQT) expression of interest (EOI) pathway for API…
Sets out EMA CHMP/HAEMWP clinical development expectations for medicines targeting sickle cell disease, including how to design confirmatory efficacy studies…
Sets out EMA CHMP clinical evidence expectations for medicines for thalassaemia, including how confirmatory efficacy/safety studies should be designed, what…
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…
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…
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…
Clarifies the 510(k) premarket notification expectations for hemodialysis blood tubing sets, outlining how manufacturers should structure device submissions to…
Prohibits the marketing/approval of 16 fixed-dose combinations (FDCs) under specified Gazette notifications, potentially affecting existing and pending…
This EMA workshop convenes multi-stakeholder input to update the EMA “Guideline on the clinical development of medicinal products intended for the treatment of…
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…
Class 4 defect notification from Teva UK Limited reports a carton labelling error for Ponlimsi (denosumab) 60 mg solution for injection in pre-filled syringe…
Amends Schedule V of the Drugs Rules, 1945 to update the unit of measurement used for folic acid, which may require regulated product labeling, specifications…
Adds a new WHO Prequalification (PQ) product entry (RH108) for an ethinylestradiol/levonorgestrel 30µg/150µg sugar-coated tablet combined with ferrous fumarate…
Committee for Herbal Medicinal Products (HMPC) meeting 4–6 May 2026 will compile and publish HMPC opinions and related outputs for questions on herbal…
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