Expertise

Clinical & Preclinical Studies

Development programmes supporting medicinal product registration

Clinical & Preclinical Studies

This section brings together clinical and preclinical work used to support medicinal product registration, including clinical-study requirements, Phase I–III development and preclinical programmes for pharmaceuticals and biopharmaceuticals.

Detailed guidance across each development stage is available below.

EAEU · Clinical / BE evidence

When EAEU Registration Requires Clinical or Bioequivalence Evidence

When EAEU drug registration requires clinical or bioequivalence evidence: generic, hybrid, biowaiver, topical, biosimilar and foreign clinical-study strategy.

 Russia · Local clinical studies

Local Clinical Studies in Russia: Protocol Development, Ministry Approval and Vendor Strategy

Russian clinical-study regulatory strategy: protocol, statistics, Investigator Brochure, informed consent, insurance, Ministry approval, CRO/site/bioanalytical-lab selection and logistics.

 EAEU · Foreign clinical data / GCP

Using Foreign Clinical Studies for EAEU Registration: When a GCP Inspection Can Replace a New Local Trial

How foreign clinical studies can support EAEU registration: Decision 78 paragraph 36, local-study alternative, unscheduled GCP inspection, risk triggers, preparation and CAPA.

 EAEU · BCS biowaiver

Can My Drug Use a BCS Biowaiver Instead of an EAEU Bioequivalence Study?

EAEU BCS biowaiver under Decision 85: Class I and III eligibility, reference product, solubility, excipients, dissolution, WHO/ICH screening and Pharegis feasibility assessment.

 EAEU · Module 4 / GLP

Preclinical Evidence for EAEU Registration: Module 4, GLP and When New Studies Are Actually Needed

EAEU Module 4 preclinical evidence: when new studies are needed, foreign GLP data, generic vs original/hybrid strategy, nonclinical gap analysis and GLP inspection risk.

 EAEU · Biologicals / Biosimilars

Preclinical Studies for Biological and Biosimilar Medicinal Products in the EAEU

EAEU biological and biosimilar preclinical strategy: Decision 89, comparability, relevant species, in-vivo studies, immunogenicity, GLP and Module 4 inspection readiness.