April 2021: Spain Regulatory Updates

Publication of Observational Studies with drugs in the Spanish Registry of Clinical Studies

AEMPS posted an update regarding the new platform for the publication of observational studies with drugs in the Spanish Registry of Clinical Studies on April 14, 2021. The trial registration and results posting activities for these will be carried out through GESTO platform, launched on 14th April 2021.

Additionally, as informed earlier by the authority, a document Instructions for conducting observational studies with drugs: Procedures, terms and data format that will be included in the Spanish Registry of clinical studies (REec) has also been made available. The document provides details in compliance with the provisions of Article 3.1 and 6.2 of Royal Decree 957/2020, of November 3. The points are summarized as below:

User account and login information:

  • Account requests and related incidents can be raised through https://servicedesk.aemps.es/servicedesk/customer/portal/2
  • The promotor (individual, company, institution or organization responsible for initiating, managing and organizing the financing study) or representative of a promotor [who will be the sole point of contact for the study promoter (applicant) from registration of trial] can register

Requirements:

  • Publication of information is mandatory for observational studies with prospective follow-up drugs and voluntary for the rest of the studies

Timelines:

  • Registration: Maximum 15 working days from the start date of the study
  • Maintenance: The updating of the data must be carried out within 15 days working from the date the CEIm has issued a favorable opinion to the substantial modification
  • Results: Results will need to be submitted within 12 months from study completion or within 30 working days from the date of publication of the same in scientific journals or other media, whichever is earlier
  • For early terminated trials, information will need to be updated within 3 months from the trial termination date

Trial registration and results posting (Data entry):

  • Details regarding the registration fields, fields that will be made public and other fields that will not be displayed publicly are available on below link, https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/estudios-PA/Instrucciones-GESTO-REEC.pdf?x74012
  • Information for the below-mentioned fields will be submitted to GESTO, however, these fields will not be published on REec:
    Promoter ID, Contact for scientific inquiries, Identification of the principal investigator/coordinator, Contact information, CEIm that approved the study, Meeting date CEIm Opinion, Study status (started, finished), End date, Summary of Results, Post link, Date of the last modification of the record in the REec
  • Results will be submitted either in the form of a summary of trial results or bibliographic reference of the published scientific article
  • The AEMPS will check the consistency of the information provided and will proceed to transfer the information to the REec

November 2020: Spain Regulatory Updates

Spain Royal Decree 957/2020, of November 3, regulating observational studies with drugs published on November 27, 2020

  • The Official State Gazette has published Royal Decree 957/2020, of November 3, which regulates observational studies with medicines for human use, and will come into force on January 2, 2021
  • This Royal Decree will replace the regulations currently in force, Order SAS / 3470/2009, and Chapter VI relating to Post-authorization Studies of Royal Decree 577/2013
  • For observational studies with drugs to which the previous one no longer applies regulations (not classified by the AEMPS), the prospective publication will be mandatory for the promoters of the follow-up studies and the information to be published at the beginning of the study will include, at least, the title, promoter, drugs under study, main objective and sources of financing.
  • The publication of information in the REec will be mandatory for  observational studies with prospective follow-up drugs and voluntary for the rest of observational studies with drugs.

Click to go to original news and article.

February 2019: Italy Regulatory Update

Activation of the new “OsSC” platform: closure of the old portal and implementation of the new transversal electronic signature method (02/14/2019)

Following the press releases published on the institutional website , the following indications are provided in relation to the closure of the old OsSC system, scheduled for 18 February 2019, and to the implementation of the new cross-electronic signature method in the new OsSC system.

Original article is available here.