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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-004109-15
    Sponsor's Protocol Code Number:1ABC
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004109-15
    A.3Full title of the trial
    Evaluation of the safety and efficacy of the treatment of chronic wounds in diabetic foot syndrome with the use of autologous stem cells isolated from adipose tissue - within the project: "Therapeutic potential of adipose-derived stem cells, proven in clinical trials and examined in vitro - rationale for banking of well characterized cells”
    Ocena bezpieczeństwa i skuteczności leczenia ran przewlekłych w zespole stopy cukrzycowej z użyciem autologicznych komórek macierzystych, izolowanych z tkanki tłuszczowej – w ramach projektu pt.: „Potencjał terapeutyczny mezenchymalnych komórek macierzystych, testowany w próbach klinicznych oraz in vitro - uzasadnienie dla bankowania scharakteryzowanych komórek”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the safety and efficacy of the treatment of chronic wounds in diabetic foot syndrome with the use of autologous stem cells isolated from adipose tissue - within the project: "Therapeutic potential of adipose-derived stem cells, proven in clinical trials and examined in vitro - rationale for banking of well characterized cells”
    Ocena bezpieczeństwa i skuteczności leczenia ran przewlekłych w zespole stopy cukrzycowej z użyciem autologicznych komórek macierzystych, izolowanych z tkanki tłuszczowej – w ramach projektu pt.: „Potencjał terapeutyczny mezenchymalnych komórek macierzystych, testowany w próbach klinicznych oraz in vitro - uzasadnienie dla bankowania scharakteryzowanych komórek”
    A.4.1Sponsor's protocol code number1ABC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Warsaw
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe National Centre for Research and Development
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Warsaw
    B.5.2Functional name of contact pointDep.ofGen.,Vasc.&TransplantSurgery
    B.5.3 Address:
    B.5.3.1Street AddressBanacha 1a
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-097
    B.5.3.4CountryPoland
    B.5.4Telephone number004822599 24 67
    B.5.5Fax number004822599 14 68
    B.5.6E-mailslawomir.nazarewski@wum.edu.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAutologous stromal vascular fraction for diabetic foot ulcers treatment
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberRef.EMA/CAT/771738/2015
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAutologous adipose derived mesenchymal stem cells for diabetic foot ulcers treatment
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberRef.EMA/CAT/771738/2015
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic foot ulcer
    Owrzodzenie w przebiegu zespołu stopy cukrzycowej
    E.1.1.1Medical condition in easily understood language
    Hard to heal wounds.
    Trudno gojące się rany.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety and efficacy of the therapy with autologous stem cells isolated from adipose tissue of the patient in the treatment of chronic wounds in the diabetic foot syndrome.
    Ocena bezpieczeństwa i skuteczności terapii autologicznymi komórkami macierzystymi izolowanymi z tkanki tłuszczowej pacjenta w leczeniu przewlekłych ran w zespole stopy cukrzycowej.
    E.2.2Secondary objectives of the trial
    Assessment of wound’s morphology: effusion, redness and / or swelling of the skin around the wound, presence of granular or fibrous.
    Analysis of the expression of selected pro-angiogenic factors in the wound treated with the studied method compared to the wound treated in standard manner.
    Ocena zmian morfologii rany: wysięk, zaczerwienienie i/lub obrzęk skóry wokół rany, obecność ziarniny lub włóknika
    Analiza ekspresji wybranych czynników pro-angiogennych w ranie leczonej badaną metodą, w stosunku do rany leczonej w sposób standardowy.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signing informed consent form.
    2. Above the age of 18
    3. Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
    4. Chronic wound in the course of diabetic foot syndrome, with duration of at least 12 weeks and the wound surface not less than 2 sq. cm and not greater than 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
    5. Blood glucose control - fasting not more than 180 mg% OR HbA1c not more than 10%.
    6. Good tolerance of the current standard of treatment lasting at least one week before including the patient into the study
    7. Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (> 20mmHg) in patients with neuropathic etiology of diabetic foot syndrome
    8. In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb’s blood supply as a result of the revascularization procedure documented by X-ray or ultrasound.
    9. Ankle-brachial index (ABI) ≥ 0.8
    10. No active infection of the wound and surrounding tissue verified by quantitative microbiological testing (105 bacteria per 1 g of tissue taken for testing from a wound)
    11. For women of childbearing potential - a negative pregnancy test result during the screening visit and using of effective contraceptive methods during participation in the research.
    1. Podpisanie dokumentu świadomej zgody
    2. Wiek powyżej 18 lat
    3. Chęć dobrowolnego udziału w badaniu, postępowania zgodnie z wymogami protokołu i akceptacji procedur związanych z jego realizacją
    4. Rana przewlekła w przebiegu zespołu stopy cukrzycowej, o czasie trwania co najmniej 12 tyg. i powierzchni rany nie mniejszej niż 2 cm2 i nie większej niż 25 cm2, bez cech czynnej infekcji rany w chwili kwalifikacji do udziału w badaniu
    5. Kontrola glikemii – na czczo nie więcej niż 180 mg% LUB poziom HbA1c nie wyższy niż 10%.
    6. Dobra tolerancja dotychczasowego leczenia standardowego, z co najmniej tygodniowym okresem jego stosowania, poprzedzającym włączenie pacjenta do badania
    7. Zadowalające ukrwienie rany, weryfikowane pomiarem poziomu wysycenia tlenem tkanek stopy (>20mmHg) u chorych z neuropatyczną etiologią zespołu stopy cukrzycowej
    8. W przypadku pacjentów z ranami z komponentą niedokrwienną warunkiem kwalifikacji jest kliniczna poprawa ukrwienia kończyny w wyniku zabiegu rewaskularyzacyjnego udokumentowana radiologicznie lub ultrasonograficznie.
    9. Wskaźnik kostka-ramię ≥0,8
    10. Brak aktywnego zakażenia rany i tkanek otaczających, weryfikowany ilościowym badaniem mikrobiologicznym (105 bakterii na 1 g tkanki pobranej do badania z rany)
    11. W przypadku kobiet w wieku rozrodczym – ujemny wynik testu ciążowego w czasie wizyty przesiewowej i stosowanie skutecznej metody antykoncepcyjnej w czasie udziału w badaniu
    E.4Principal exclusion criteria
    1. Lack of patient’s cooperation
    2. Ischemia of lower limbs; ankle-brachial index <0.8; significant vein component in medical patient’s history shown in the Duplex-Doppler tests made within 6 months before joining the research.
    3. Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study
    4. No clinical improvement after revascularization procedures performed on the vascular system of the treated limb during the last 2 weeks
    5. Venous thromboembolism in the past 3 months preceding participation in the research
    6. Sings of severe osteolysis and / or bone and marrow infection around wounds on the basis of the result of X-ray, CT or MRI of the feet made within 6 months before participation in the study.
    7. The active inflammation phase in the course of Charcot's neuroartropathy.
    8. Treatment with antibiotics, immunosuppressive therapy, including systemic steroid therapy (excluding inhaled medicines) at the time of joining the study.
    9. Chronic diseases in the stage of exacerbation, not stabilized, that in the opinion of the investigator may hinder or make impossible a patient’s participation in the study and reviewed on the basis of subjective and objective examination and laboratory tests carried out during the screening visit (blood type, morphology, electrolytes, coagulation system, blood glucose, urea, creatinine, and viral tests). Test results behind laboratory standards for a specific parameter are considered as incorrect. In the case of treatment with vitamin K antagonists, normal ranges suitable for this treatment will apply.
    10. Known allergic reactions to ingredients of dressing (thrombin, penicillin).
    11. The diagnosis of AIDS, HBV or HCV
    12. Reactive result of serological and viral tests:
    HIV-1 and 2 (HIV Ag / Ab);
    Hepatitis B Virus Infection, Anti-HBc;
    Hepatitis C Virus Infection, Anti-HCV;
    Syphilis specific tests

    1. Brak współpracy chorego
    2. Niedokrwienie kończyn dolnych; wskaźnik kostka-ramię <0.8; w wywiadach istotna komponenta żylna wykazana w badaniu Duplex-Doppler wykonanym w ciągu 6 miesięcy przed włączeniem do badania.
    3. Czynna choroba nowotworowa, w trakcie chemio- lub radioterapii, lub przebyta choroba nowotworowa, jeżeli od uzyskania remisji nie upłynęło co najmniej 5 lat
    4. Brak klinicznej poprawy po zabiegach rewaskularyzacyjnych wykonywanych na układzie naczyniowym leczonej kończyny w okresie ostatnich 2 tygodni
    5. Choroba zakrzepowo-zatorowa w ciągu ostatnich 3 miesięcy, poprzedzających włączenie do udziału w badaniu
    6. Cechy nasilonej osteolizy i/lub zakażenia kości i szpiku w okolicy rany w oparciu o wynik badania RTG, TK lub MRI stopy wykonanych w ciągu 6 miesięcy przed włączeniem do badania.
    7. Faza aktywnego zapalenia w przebiegu neuroartropatii Charcota.
    8. Leczenie antybiotykami, leczenie immunosupresyjne, w tym steroidoterapia systemowa (z wyłączeniem leków stosowanych wziewnie) w chwili włączenia do badania.
    9. Choroby przewlekłe w stadium zaostrzenia, niewyrównane, które w opinii badacza mogą utrudnić lub uniemożliwić pacjentowi udział w badaniu, weryfikowane na podstawie badania podmiotowego i przedmiotowego oraz badań laboratoryjnych wykonanych w ramach wizyty screeningowej ( grupa krwi, morfologia, jonogram, układ krzepnięcia, poziom glikemii, mocznik, kreatynina, układ krzepnięcia oraz badania wirusologiczne). Wyniki badań nie mieszczące się w normach laboratoryjnych dla danego parametru uznawane będą za nieprawidłowe. W przypadku leczenia antagonistami witaminy K stosowane będą normy odpowiednie dla tego leczenia.
    10. Znane reakcje alergiczne na składniki opatrunku (trombina, penicylina).
    11. Rozpoznanie AIDS, HBV lub HCV
    12. Reaktywny wynik badań serologicznych i wirusologicznych:
    • HIV-1 i 2 (HIV Ag/Ab);
    • wirusowe zapalenie wątroby typu B-HbsAg i Anty HBc;
    • wirusowe zapalenie wątroby typu C-Anty-HCV;
    • kiła testy swoiste



    E.5 End points
    E.5.1Primary end point(s)
    Time needed for a 50% reduction in wound size in comparison to the original volume
    Czas potrzebny na zmniejszenie o 50% wielkości rany w stosunku do wielkości początkowej
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first occurence.
    Czas jaki upłynie do pierwszego wystąpienia
    E.5.2Secondary end point(s)
    Evaluation of changes in the morphology of the wound, and expression analysis of selected proangiogenic factors in the wound treated with the tested method (AKM), relative to the wound being treated in a standard way.
    Ocena zmian morfologii rany oraz analiza ekspresji wybranych czynników pro-angiogennych w ranie leczonej badaną metodą (AKM), w stosunku do rany leczonej w sposób standardowy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to first occurence.
    Czas jaki upłynie do pierwszego wystąpienia.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Materiał hydrowłóknisty lub piankowy -z nanosrebrem w okresie przesiewowym, bez nanosrebra w badaniu
    Hydro-fibrous or foam material (with nanosilver at screening,without nanosilver during the study).
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    When the complete healing of wound is achieved or 6 weeks after the first application (whatever occurs first).
    In case of an adverse event or in any other situation in which (in the investigator’s opinion) the patient continued participation in the study may jeopardize his health.
    In case of relevant violation of the study protocol by the patient and the withdrawal of his consent to participate in the study.

    W chwili uzyskania całkowitego wygojenia rany, lub po 6 tyg. od pierwszej aplikacji (w zależności od tego, co nastąpi pierwsze).
    W przypadku wystąpienia zdarzenia niepożądanego, lub w innej sytuacji, w której, w opinii badacza, dalszy udział pacjenta w badaniu może stanowić istotne zagrożenie dla jego zdrowia.
    Podstawą do wcześniejszego zakończenia badania może być istotne naruszenia protokołu badania przez pacjenta oraz wycofanie jego zgody na udział w badaniu.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If after 6 weeks since the first application the complete healing of the wound is not achieved then the patient will be further treated in accordance with standard of care for the healing diabetic foot ulcer.
    Jeśli po 6 tygodniach od pierwszej aplikacji nie dojdzie do całkowitego zagojenia rany, chory będzie dalej leczony zgodnie z zasadami leczenia ran w przebiegu stopy cukrzycowej.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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