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Europe

Set Alert for Europe

EU Fees Revision A ‘Once-In-A-Generation’ Chance To Solve Resource Challenges

COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.

User Fees Legislation

EU Pilots New 'Stepwise' Approach To Pediatric Investigation Plans

New EU guidance has been published to help the European Medicines Agency and drug developers agree on the conduct of pediatric investigation plans (PIPs) when crucial information is not yet available. 

Europe Pediatrics

New French Body To Lead Efforts Against Drug Shortages

A new committee including representatives of the French pharma industry, health professionals and patients is to lay the groundwork for a longer-term approach to preventing and managing medicine supply chain issues. A separate initiative launched by the prime minister will look at medicines access issues and strengthening the French manufacturing base.

Europe France

EMA Clarifies Questions Over Biosimilar Interchangeability

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Biosimilars Regulation

‘Decentralized Clinical Trials 2.0’ On The Horizon

The remarkable shift towards decentralized clinical trials in the last three years is a testament to how this patient-centric approach of doing research has the potential to solve multiple issues such as time, cost and low participation rates. In this first segment of a two-part article, Pink Sheet looks at how innovation in this sector has just begun and we can expect more action ahead. 

Pink Sheet Perspectives Clinical Trials

Who Will Join Us? EU Regulators Seek Feedback On Proposed Clinical Trials Discussion Platform

Regulators want to know who is interested in joining their planned multi-stakeholder platform for discussions on how to improve clinical trials in Europe. They are also seeking feedback on which topics should be prioritized for discussion.

Europe Clinical Trials

Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation

Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.

Artificial Intelligence FDA

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

EU Falsified Medicines Directive ‘Not Working’ In Northern Ireland

Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”

Europe United Kingdom

UK Industry Urges Government To Drop Statutory Pricing Scheme Rate Hike

The ABPI, which represents the R&D-based pharmaceutical industry in the UK, says the proposed increase in the statutory scheme rebate sends "the worst possible signal" to global investors and boardrooms.

Europe United Kingdom

EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency

A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.

Europe Clinical Trials

Next UK Drug Pricing Scheme Needs ‘Single-Digit Fixed Rebates’

The pharmaceutical industry and the UK government are beginning a series of discussions on the shape of the future voluntary drug pricing and access scheme (VPAS), ahead of the formal negotiations that are scheduled to start in April.

Europe United Kingdom
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