COMMISSION DIRECTIVE (EU) 2015 565

COMMISSION DIRECTIVE 2006 17 (EC)

COMMISSION DIRECTIVE 2006 86 (EC)

DIRECTIVE 2001 18 (EC)

DIRECTIVE 2004 23 (EC)

DIRECTIVE 2009 120 (EC)

EC_GCP for ATMPs_2019

EC_report_mplementation of Directives setting standards of quality and safety for human tissues and cells._2016

EMA_guideline quality non-clinical clinical aspect medicinal products containing genetically modified_2020

REGULATION (EC) No 1394 2007

Animpact_final report

DIRECTIVE 2004 9 (EC)

DIRECTIVE 2004 10 (EC)

DIRECTIVE 2010 63 (EU)

EC Rec 2007 526

EMA_guideline adjuvants vaccines human use_2005

EMA_guideline need non-clinical testing juvenile_2008

EMA_note guidance preclinical-pharmacological-toxicological-testing-vaccines_1997

ich guideline_s5-r3_reproductive toxicology_2020

ich_s8_immunotoxicity studies human pharmaceuticals_2006

ich_s11_nonclinical safety testing_2020

WHO Guideline on non-clinical evaluation vaccines_2005

EMA_qualification novel methodologies_2014

ich_e15_genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic data and samples_2007

Additional Protocol to the Oviedo Convention_2005

CoE. CM Rec (2016)6 research on biological material

Declaration of Helsinki_2013

DRAFT-iCONSENT-Guidelines

Explanatory Report to the Oviedo Convention_1997

Oviedo Convention_1997

WHO-CIOMS_Ethical Guidelines_2016

CIOMS-Cumulative-Glossary_v1.1_2021

COMMISSION DIRECTIVE 2005 28 EC

DIRECTIVE 2001 20 EC

draft ich guideline_e6 good clinical practice_2021

draft ich guideline_e8-r1_general considerations on clinical studies_2019

EC, EMA and HMA. Brexit_technicalnotice_2020

EMA – Reflection paper on ethical and GCP aspects of clinical trials_2012

EMA_clinical trial information system_sponsor handbook_2021

EMA_implications of covid19 in ongoing clinical trials_2020

EMA-HMA. Guidanceclinicaltrials_covid19_2021

EnprEMA_informed consent guidance for paediatric clinical trials_2021

EnprEMA_preparedness medicines clinical trials_paediatrics recommendations_2020

HMA_CTFG_VHP_sponsor_version 5_2020

ich E6_R2_Addendum_2016

ich guideline_e6-r1_good clinical practice_2016

ich_e9-r1_addendum estimands sensitivity analysis_ct guidelin_2020

REGULATION (EU) No 536 2014 – Clinical Trials Regulation

Regulation5362014_qa_en_V4.1_2021

EC. ms_rules_health-data_2021

edpb_application of the GDPR on health research_2021

edpb_guidelines_art46guidelines_internationaltransfers_v2_2020

edpb_guidelines_consent_2020

edpb_guidelines_dataprotection by design and by default_v2.0_2020

edpb_guidelines_health data scientific research covid19_2020

edpb_guidelines_territorial scope_2019

edpb_Q&A on the interplay between GDPR and CTR_2019

edpb_recommendations_supplementarymeasurestransferstools_2021

edpb_statement_processing personaldataandcovid-19_2020

eppb_guidelines_controllerprocessor_2021

International_Health_Data_Transfer_2021

REGULATION (EU) 2016 679 – GDPR

edpb_guidelines_codesofconducttransfers_en_2022

Additional Protocol to the Convention on Human Rights and Biomedicine concerning genetic testing_2008

International Declaration on Human Genetic Data_2003

Nagoya protocol_2011

Rec(92)3E on genetic testing_1992

EC_Joint evaluation of the Orphan and Paediatric Regulations_2020

EMA_checklist transfer orphan designation_2020

EMA_decision fee reductions_2020

EMA_IRIS guide for applicants_2021

EMA_IRIS_guide registration_2021

EMA_procedural advice appeal procedure orphan designation review_2020

ev_report_Medicines for Rare Diseases and Children_2019

REGULATION (EC) No 141 2000

REGULATION (EC) No 847 2000

EMA_guidance procedural advice orphan designation_2021

EC_ethical consideration on clinical trials with minors_2017

EC_Joint evaluation of the Orphan and Paediatric Regulations_2020

EMA_guideline on the investigation of medicinal products in neonates_2009

EMA_guideline_role of pharmacokinetics development medicinal products paediatric population_2006

EnprEMA_preparedness medicines clinical trials_paediatrics recommendations_2020

ich guideline_e11-r1_clinical investigation medicinal products pediatric population_2017

REGULATION (EC) No 1901 2006

EMA_guidance paediatric submissions_2021

EMA_Notice to stakeholders_UK withdrawal 2020

EMA_patients repurposing_2020

EMA_practical guidance brexit_2020

ich_reflection paper_patient-focused drug development_2021

OECD_Collaborative_Genomics_&_Biobanks_2021