TGA Gives Companies Deadline To Complete Australian Pharmacovigilance Risk Survey
The Therapeutic Goods Administration warned that companies that fail to complete its survey for prioritizing pharmacovigilance inspections will be assigned the highest survey risk score.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add five new products, including Enjaymo, Sanofi’s treatment for hemolytic anemia in adult patients with cold agglutinin disease.
The European Patent Office has adjusted the starting date of its transitional measures for applicants that want their patent to have unitary effect under the coming Unified Patent Court system.
New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments
The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.