437 guidances, approvals and safety alerts affecting clinical, collected from official agency sources. Showing the 30 most recent.
Facilitates an EMA bilateral dialogue with the ISCT to exchange views on topics of common interest, with a focus on how industry and regulators coordinate on…
Mandates ISO/ICH E2B(R3) formats for individual case safety reporting (ICSRs) in the EU, effective since 30 June 2022, and drives operational readiness through…
Clarifies how the EMA Product Management Service (PMS) makes data available through the Product User Interface (PUI) and the PMS API for centrally authorised…
Provides an EMA Q&A clinic format for companies to ask questions about the XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) service, with monthly…
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…
CTIS Walk-in clinic (Oct 7, 2026) provides sponsor organisations practical Q&A on CTIS system functionalities, with questions about the interpretation of the…
Provides an EMA regulatory data management Q&A session covering Substance, Organisation, Referentials (SPOR) management services, including how EMA’s services…
Solicits RFQs from interested European Notified Bodies to expand WHO’s technical assessment capacity for the prequalification assessment of medical devices and…
Launches WHO Prequalification of Medical Devices via an informational webinar, indicating an institutionalized pathway for manufacturers to seek WHO…
Expands access to WHO Emergency Use Listing diagnostics by listing the Xpert® Hemorrhagic Fever Panel under the WHO Emergency Use List for Bundibugyo virus…
Convenes an expert panel to examine MAID (medical assistance in dying) in the context of mental illness, which may inform future Health Canada policy…
Health Canada lists the “Appropriate Use Advisory Committee” as an advisory body, indicating an organizational mechanism for expert input on matters related to…
Establishes an Implementation Advisory Group (IAG) to support execution of Canada’s National Strategy for Drugs for Rare Diseases, providing a structured forum…
Establishes/announces Health Canada’s Scientific Advisory Committee on Mental Health Disorders, which may influence how scientific evidence is reviewed and…
Science Advisory Committee updates for Health Canada’s health products containing cannabis may shape how evidence, quality, and safety considerations are…
Adds the DiaCarta Inc. QuantiVirus MPXV Test Kit to WHO’s Emergency Use Listing (EUL) for mpox diagnostics, enabling countries and procurers to source…
Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…
Expands the WHO API prequalification Expression of Interest (EOI) process to include additional APIs—Hydrocortisone (sodium succinate), Dactinomycin…
Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product…
Invites manufacturers to submit Expressions of Interest for WHO Prequalification evaluation of specific childhood cancer medicines, including six paediatric…
Adds QCIL’s artemether/lumefantrine 20 mg/120 mg tablet (MA211) to the WHO Prequalification list, supporting availability of a quality-assessed ACT from…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
Establishes standardized E2B(R3) electronic transmission requirements for individual case safety reports (ICSRs), including detailed data elements and message…
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…
Provides a curated safety update for medicines and medical device users, highlighting the latest safety advice issued by the MHRA.
Updates between 20 June and 21 July 2026 revised multiple WHO Public Assessment Reports (WHOPAR) for in vitro diagnostics to reflect changes in product…
Launches the first WHO PQT invitation for manufacturers to submit an Expression of Interest (EOI) for evaluation of hydroxyurea products for the treatment of…
Organizes an EMA/EMRN multistakeholder workshop to identify evidence gaps and practical actions to strengthen women’s health research and regulatory…
Promotes structured collaboration to address gaps in real-world data (RWD) collection for Duchenne muscular dystrophy, with the goal of generating meaningful…
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