October 2025
Updates for October 2025 include fee increases in Venezuela; Belgium's accelerated assessment timelines beginning January 2026; the UK's final guidance for regulations effective April 2026 covering transparency requirements including prospective registration and results publication; Indonesia's registry migration to a new website; ISRCTN accepting registrations during ClinicalTrials.gov delays; ANZCTR's prioritization policy for Australian/New Zealand trials; the EU's updated assessment guidance addressing common application issues; and WHO's establishment of the Global Clinical Trials Forum.
Venezuela Clinical Trial Fee Update (Oct. 1, 2025)
The National Institute of Hygiene "Rafael Rangel" has published updated clinical trial fees for October 2025. Evaluation fees have increased across all categories, with Phase I–III trials now set at VEF 148,182.80 (up from VEF 118,642.15) and Phase IV trials at VEF 100,705.57 (up from VEF 80,629.64). Amendment fees have also risen; minor amendments are now VEF 23,738.62 (up from VEF 19,006.26), and major amendments are VEF 66,933.11 (up from VEF 53,589.81).
Indonesia Clinical Trial Registry Site Migration (Oct. 1, 2025)
The Indonesian Clinical Research Registry (INA-CRR) has migrated to a new site at ina-crr.kemkes.go.id, replacing the previous ina-crr.id address. To register for clinical trials, sponsors must log in to the new site. Users with existing accounts must contact Binomika Admin/IT Support for assistance with account access. Contact details: email [email protected] or phone/WhatsApp +62 821-2392-7879 or +62 851-5539-4885
United Kingdom Clinical Trials Regulations Final Guidance (Oct. 1, 2025)
The Health Research Authority (HRA) has published final guidance for the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, effective April 28, 2026. Transparency requirements include mandatory trial registration in public registries before recruiting the first participant or within 90 days of approval (whichever is sooner), results publication within 12 months, and offering to share plain-language results summaries with participants.
WHO Global Clinical Trials Forum Established (Oct. 7, 2025)
The WHO has established the Global Clinical Trials Forum as a multi-stakeholder network and collaborative platform. Membership is open to eligible stakeholder organizations committed to implementing WHA75.8 and WHO's Guidance for Best Practices for Clinical Trials. Members can collaborate with global experts, contribute to initiatives, and help shape clinical trial ecosystems.
Belgium Accelerated Clinical Trial Assessment Timelines (Oct. 14, 2025)
From Jan. 1, 2026, the Federal Agency for Medicines and Health Products (FAMHP) will implement accelerated evaluation timelines for clinical trial applications, approximately half of the previous timeframe. Single-country Phase I, I/II, and II trials will be assessed within 20 days (59 days with additional information); Phase II/III, III, III/IV, and IV trials within 35 days (79 days with additional information).
ISRCTN Available During ClinicalTrials.gov Delays (Oct. 14, 2025)
ISRCTN, the UK's WHO Primary Registry, is accepting clinical trial registrations from UK and global studies while ClinicalTrials.gov experiences submission delays. The registry is recognized by WHO and ICMJE, provides unique identification numbers required for publication, and accepts all clinical research studies (proposed, ongoing, or completed). Studies should be registered prospectively, though retrospective registration is accepted.
European Union CTR Assessment Guidance Update (Oct. 29, 2025)
The Clinical Trials Coordination Group (CTAG) has published recommendations addressing frequent Part I and Part II assessment issues. Guidance covers IMPD requirements (stability data, manufacturing site documentation), protocol essentials (termination criteria, statistical analysis, placebo justification), and Part II elements (age-appropriate PIS/ICF, secondary data use consent, post-trial access provisions).
ANZCTR International Registration Prioritization (Oct. 29, 2025)
The Australian New Zealand Clinical Trials Registry (ANZCTR) now prioritizes trials from Australia and New Zealand. International applicants face processing delays of up to eight weeks per review cycle for new accounts and study reviews. Prioritization order: (1) trials with Australia/New Zealand recruitment sites, (2) countries without WHO Primary Registries, (3) countries with existing WHO Primary Registries. ANZCTR encourages the use of local WHO Primary Registries.