Neena has been covering regulatory, business and market access developments that impact pharmaceutical and medical device companies since 1997. She explores the challenges and opportunities that developments worldwide introduce for industry and regulators. Her areas of expertise include regulatory schemes for getting products to market faster. Neena's other specialist areas include new medicines coming to market in the EU, pricing and reimbursement, clinical trials, real-world evidence, post-marketing safety monitoring, transparency policies relating to the publication of trial data, and global harmonization initiatives for pharma and medtech.
Latest From Neena Brizmohun
The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.
Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.
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.
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.