Europe

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.

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. 

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.

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.

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. 

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.

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

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.

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.”

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.

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.

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.