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Latest Life Sciences News

EFPIA research reveals lower cost estimates for EU pharma reform's antibiotic voucher scheme

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released research on 25 April 2025 showing the proposed transferable exclusivity voucher (TEV) system would cost EU Member States €162m per voucher, 45% less than the European Commission's original €294m estimate. The TEV scheme, part of the EU's 2023 pharmaceutical legislation reform package, would grant pharmaceutical companies a one-year extension of regulatory data protection on existing products as an incentive for developing new antibiotics. The research, conducted by Charles Rivers Associates, indicates the cost reduction stems from proposed legislative safeguards against overcompensation.

HRA announces new mandatory clinical trial transparency requirements for 2026

The Health Research Authority (HRA) has outlined new legal requirements for clinical trials coming into force in spring 2026. The regulations will make it mandatory for researchers to register trials in public registries, publish results within 12 months of completion, and share findings with participants in an accessible format. The HRA reports current voluntary registration compliance at 92%, with commercial trials showing higher rates than non-commercial studies. The authority is developing guidance with the Medicines and Healthcare products Regulatory Agency to support implementation, including provisions for exemptions in cases such as national security.

EPC adopts new pharmacopoeia chapter on viral testing standards

The European Pharmacopoeia Commission (EPC) has adopted a new general chapter (2.6.41) on high-throughput sequencing for viral contaminant detection in biological products. The chapter, adopted in March 2025, will be published in European Pharmacopoeia Issue 12.2 in October 2025 and enter into force on 1 April 2026. The new standards align with ICH Q5A(R2) guidelines and WHO reference standards, establishing unified requirements for testing biological products including vaccines, recombinant proteins, and cell-based preparations.

EMA and ICH release two new Step 2b guidelines on drug development

The European Medicines Agency (EMA) and International Council for Harmonisation (ICH) have published two new Step 2b guidelines in April 2025. The ICH M15 guideline, published on 16 April, establishes a harmonised framework for evaluating model-informed drug development evidence, while the ICH Q1 guideline on stability testing of drug substances and products was released on 11 April. Both guidelines aim to standardise pharmaceutical development processes across jurisdictions. The M15 guideline follows a consultation period that concluded on 28 February 2025, while the Q1 guideline has now entered its public consultation phase.