Addresses regulatory and safety considerations in the clinical development of new antibacterial therapies, emphasising benefit-risk optimisation in adults and tailored safety and PK strategies for paediatric populations.

Features practical insights into the role of regulatory agencies—particularly the EMA—and guidance on how developers can effectively engage with regulators throughout the drug and vaccine development process.

Presents the MHRA Innovation Office’s free, confidential support services for healthcare innovators, showcasing how it assists organisations developing novel medicines, medical devices, and manufacturing technologies through expert regulatory advice and guidance.

Guides product developers on the purpose and preparation for pre-IND meetings, featuring regulatory insights and practical experience.

Explains the information developers should provide when seeking early FDA advice, including CMC, toxicology, microbiology, resistance, clinical isolates, animal models and initial clinical development plans.

Follows a fictional small pharmaceutical company through the US drug development and approval process, from nonclinical testing and IND submission to clinical trials, NDA review, approval and post-marketing activities. It explains key regulatory milestones, interactions with the FDA, informed consent, safety reporting and available approval pathways.

Provides an overview of how medicines are developed, assessed and authorised in the European Union. It explains the centralised and national authorisation routes, the respective roles of EMA, the European Commission and national authorities, clinical testing requirements, and how medicines are monitored for safety after approval.

Explains flexible development approaches for new antibacterial therapies intended for patients with serious bacterial infections and unmet medical need, particularly infections caused by drug-resistant organisms. Presented as questions and answers, it covers eligible products, nonclinical evidence, clinical trial design, PK/PD and dose selection, safety requirements, and regulatory considerations for limited or difficult-to-study patient populations.

Outlines the microbiology data needed to support the clinical development and approval of systemic antibacterial drugs. It covers antibacterial spectrum and mechanism of action, resistance studies, susceptibility testing and interpretive criteria, animal models, microbiology data collected during clinical trials, and the presentation and post-marketing update of these data.

Outlines clinical development and trial design considerations for antibacterial drugs intended to treat uncomplicated urinary tract infections (uUTIs). It covers target populations, dose selection, microbiological testing, comparators, efficacy and safety endpoints, assessment timing, statistical considerations and evidence needed to support approval.

Outlines clinical development and trial design considerations for antibacterial drugs intended to treat complicated urinary tract infections (cUTIs). It covers target populations and enrolment criteria, microbiological testing, PK/PD and dose selection, comparators, treatment duration, efficacy and safety endpoints, assessment timing and statistical considerations needed to support approval.

Assists sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP).

Assists sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP).

Sets out the non-clinical safety studies needed to support the progression of pharmaceuticals into human clinical trials and towards market authorisation. It provides internationally harmonised recommendations on the scope and timing of studies—including safety pharmacology, toxicity and dose selection—at different stages of clinical development.

EMA guideline outlines the clinical development and evaluation requirements for medicines intended to treat bacterial infections. It covers microbiological and PK/PD evidence, dose selection, susceptibility testing, clinical trial design and endpoints, non-inferiority and superiority approaches, and development strategies for drug-resistant infections and areas of unmet medical need.

Outlines the UK regulatory requirements for developing and supplying bacteriophage therapies for human use. It covers legal status, licensed and unlicensed supply routes, manufacturing and importation, GxP standards, clinical trials, marketing authorisation, regulatory submissions and safety monitoring.

Explains how medicine developers can obtain scientific advice on quality, non-clinical, clinical and regulatory aspects throughout a product’s lifecycle. It covers the types of advice available, including joint MHRA–NICE advice, and the application process, supporting documents, timelines and fees.

Overview of how to apply for a UK marketing authorisation for a medicine. It covers application routes and submission requirements, use of the MHRA portal, product naming, fast-track requests, validation and rejection, and applicable fees.

Explains how medicine developers can obtain scientific advice on quality, non-clinical, clinical, methodological and overall development strategy.