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Neena Brizmohun

Deputy Editor

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

Cough Medicines Containing Pholcodine To Be Withdrawn In EU

The opioid, which has been used as a cough suppressant since the 1950s, should no longer be marketed, according to a safety review by the European Medicines Agency.

Europe Drug Safety

EMA To Address Problems With CTIS By Key January Deadline

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.

Clinical Trials Europe

Pakistan Proposes Risk-Based Inspections Approach ‘Capable Of Revealing Weaknesses’

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.

Pakistan Manufacturing

New EU Approvals

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.

Europe Approvals

EPO Supports Early Unitary Patent Uptake From 1 January

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.

Intellectual Property Legal Issues

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.

Innovation Manufacturing
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