Portugal

Portugal

National Registry for Clinical Studies (RNEC)

Verified on March 9, 2023

Portugal has a clinical trials registry, the National Registry for Clinical Studies (RNEC). It is not a World Health Organization (WHO) recognized primary registry. It has provision for posting the protocol registrations for studies conducted in Portugal. Results of the clinical trials conducted in Portugal must be submitted to European Clinical Trials Database (EudraCT). From 31 January 2022, European Union Clinical Trial Information System (EU CTIS) has become functional and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTIS Not Applicable Competent authority, Sponsor Clinical Trial Application

Interventional

(Phase 1-4) 		English
EU CTR EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

(Phase 1-4) 		English
CEIC Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

 English
Portuguese
RNEC Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

 English
Portuguese
EU PAS EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTIS Registration

Yes

 Prior to enrollment
Results

Yes

 Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)
EU CTR Registration

Yes

 Prior to Enrollment
Results

Yes

 Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies)
CEIC Registration

Yes

 Prospective
Results

n/a

 Not applicable (NA)
RNEC Registration

Yes

 Prospective
Results

n/a

 NA
EU PAS Registration

Yes

 Before the start of data collection
Results

Yes

 Within 12 months of the end of data collection

Registry Updates

  • March 2023: CTIS Newsflash - On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • March 2023: CTIS Newsflash - On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • February 2023: Clinical Trials Highlights - On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page. Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of … Continue reading "February 2023: Clinical Trials Highlights"

References