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EU Legislative Reform

Set Alert for EU Legislative Reform

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which will revise and replace the existing general pharmaceutical legislation and represent the largest reform for the rules governing medicines in the EU in almost 20 years. The next step involves the legislation reform package entering the legislative process at the European Parliament and the Council of the EU for debate and potential amendments. The final version of the package will need to be approved by the EU member states by a qualified majority vote.

EU Regulatory Reforms Mean Many Orphan Drug Producers Won’t Benefit From Incentives

The EU’s regulatory reform package if unchanged could make orphan drug development less attractive, warn industry representatives.

Europe Gene Therapy

What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

Europe Regulation

EU Pharma Revision: Legislators Prepare For Long-Haul Debate

The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.

Europe Legislation

EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

Europe Legislation

EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'

The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.

Europe Compliance

EU Pharma Revision Proposes Changes To Drug Safety Reporting

The proposed revision of the EU medicines legislation would retain the rules on safety monitoring and reporting much as they are at present, albeit with a few significant changes.

Europe Drug Safety

EU’s Plans for Regulatory Data Protection ‘Unworkable’

The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.

Europe Intellectual Property

EU Proposal Seeks To Address Borderline Product Classification ‘As Early As Possible’

The European Commission’s draft regulation for reforming the EU medicines legislation has proposed a new product classification mechanism for borderline cases where it is not clear if a product is a medicine or falls under another area such as medical devices.

Europe EU Legislative Reform

EU’s Proposed Emergency Approval Route For Crisis-Related Products – Would It Work?

The temporary emergency marketing authorization, or TEMA, would be similar to the existing conditional approval while lasting only for the duration of the health crisis. But one law firm queries whether the new mechanism would be any faster in practice.

Europe Coronavirus COVID-19

EU Proposals On R&D Funding Transparency Could Increase Pressure On Companies Negotiating Drug Prices

The draft Directive that was published last month with a draft Regulation for reforming the EU’s medicines legislation includes proposals for companies to publicly declare financial support received from a public authority or publicly funded body for R&D activities.

Europe Financing

EU Reforms Include ‘Prudent-Use’ Targets For Cuts To Antibiotic Consumption

The European Commission says at least 65% of all human consumption of antibiotics should be of products that come under the World Health Organization’s AWaRe (Access, Watch, Reserve) classification, which have a lower risk of resistance.

Europe Infectious Diseases

EU Plans To Trial Antimicrobial Voucher Scheme For 15 Years

Proposals for an EU voucher that would encourage the development of “game-changing” antimicrobials are accompanied by plans for procurement mechanisms to guarantee revenues for companies regardless of sales volumes. But one law firm said the conditions attached to the voucher were so strict that the scheme appeared “unworkable.”

Europe Regulation