460 guidances, approvals and safety alerts affecting manufacturing, 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…
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…
Provides an EMA regulatory data management Q&A session covering Substance, Organisation, Referentials (SPOR) management services, including how EMA’s services…
CTIS Walk-in clinic (Oct 7, 2026) provides sponsor organisations practical Q&A on CTIS system functionalities, with questions about the interpretation of the…
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…
Establishes an Implementation Advisory Group (IAG) to support execution of Canada’s National Strategy for Drugs for Rare Diseases, providing a structured forum…
Science Advisory Committee on Pest Control Products provides an expert forum to inform Health Canada’s regulatory decisions affecting pest control product…
Science Advisory Committee updates for Health Canada’s health products containing cannabis may shape how evidence, quality, and safety considerations are…
WHO prequalification has been granted for bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited, supporting its availability as a…
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…
Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product…
Adds QCIL’s artemether/lumefantrine 20 mg/120 mg tablet (MA211) to the WHO Prequalification list, supporting availability of a quality-assessed ACT from…
Expands the WHO API prequalification Expression of Interest (EOI) process to include additional APIs—Hydrocortisone (sodium succinate), Dactinomycin…
Invites manufacturers to submit Expressions of Interest for WHO Prequalification evaluation of specific childhood cancer medicines, including six paediatric…
WHO prequalification has been granted for pyrazinamide manufactured by Resonance Specialities Limited under the WHO API prequalification procedure, enabling…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
WHO prequalifies Lamivudine API manufactured by Jiangxi Desano Pharmaceutical Co. Ltd., enabling manufacturers of finished pharmaceutical products (FPPs) for…
Revision of the Swissmedic guidance for authorisation of biosimilars may refine the regulatory expectations for demonstrating biosimilarity, including how…
Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances, indicating that regulatory expectations…
Clarifies or updates Swiss guidance on the conditions and documentation expectations for importing human medicinal products under Art. 14 para.
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…
Adds hydroxyurea API for products used to treat sickle cell disease to the WHO Prequalification Unit (PQT) expression of interest (EOI) pathway for API…
Organizes an EMA/EMRN multistakeholder workshop to identify evidence gaps and practical actions to strengthen women’s health research and regulatory…
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