DIRECTORATE-GENERAL
PRE AUTHORISATIONR&DResearch and Development DIVISION (HUMAN)
CLINICAL TRIAL AUTHORISATIONS
CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial closed (initial)
of which
substantial changes or amendments closed
of which
according to European Directive 2001/20
within the framework of the pilot project for preparation of the European Regulation 536/2014
23 files or 97 % of the files were processed within the deadline.
according to European Directive 2001/20
within the framework of the pilot project for preparation of the European Regulation 536/2014
100 % of the files were processed within the deadline.
of clinical trial applications according to the European Directive 2001/20
of applications for substantial amendments closed according to the European Directive 2001/20
Trend
An increasing trend of substantial changes compared to previous years because of the increasing complexity and the longer duration of clinical trials
The number of initial CTAClinical Trial Application - file for obtaining an authorisation for a clinical trial files submitted within the framework of the pilot project started in May 2017 has gradually increased over the course of 2018 to a general percentage of 6 % of the total number of initial CTAClinical Trial Application - file for obtaining an authorisation for a clinical trial files submitted to the department of Research and Development (human use). In the last trimester of 2018, 10 % of the initial files were submitted according to the CTRClinical Trial Regulaiton procedure of the pilot project.
QUESTIONS CONCERNING CLINICAL TRIALS OR RESEARCH AND DEVELOPMENT
ANNUAL SAFETY REPORTS
EUROPEAN PILOT PROJECT ABOUT THE VOLUNTARY HARMONISATION PROCEDURE
COMPASSIONATE USE AND MEDICAL NEED PROGRAMS
UMNUnmet Medical Need - faster access to reimbursement of molecules for which the authorisation procedure is ongoing, based on the therapeutic value, potential for access to a reimbursement ''outside indication'' programs submitted of which
UMNUnmet Medical Need - faster access to reimbursement of molecules for which the authorisation procedure is ongoing, based on the therapeutic value, potential for access to a reimbursement ''outside indication'' programs closed of which
substantial amendments of which
programs reevaluated of which
initial programs treated within the statutory timeframes
Trend
A 52 % increase in the number of UMNUnmet Medical Need - faster access to reimbursement of molecules for which the authorisation procedure is ongoing, based on the therapeutic value, potential for access to a reimbursement ''outside indication'' programs
Therapeutic areas of new applications
CLINICAL INVESTIGATIONS ON MEDICAL DEVICES
clinical investigations with medical devices of which
65 % files of clinical investigation on medical devices treated within the statutory timeframes
Trend
A 68 % increase of clinical investigation on medical devices.
On average over the last four years, there has been an annual increase in submissions of 20 %.
APPLICATION FILES FOR OBTAINING A MARKETING AUTHORISATION
Files closed of which
new MAsMarketing authorisation via NPNational procedure - national procedure for obtaining a marketing authorisation for medicines
new MAsMarketing authorisation via MRPMutual Recognition Procedure – mutual recognition procedure for obtaining a marketing authorisation for medicines or DCPDecentralised procedure - decentralised procedure for obtaining a marketing authorisation for medicines
variations for which Belgium was rapporteur or co-rapporteur via CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines
renewals for which Belgium was rapporteur or co-rapporteur via CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines
Belgium as RMSReference Member State
HOMEOPATHIC MEDICINES
Files closed
applications for MAMarketing authorisation
HERBAL MEDICINES
new applications for MAMarketing authorisation
variations
five-yearly renewals
Belgium as RMSReference Member State
Files closed
MEDICINES FOR VETERINARY USE DIVISION
CLINICAL TRIAL AUTHORISATIONS
FILES FOR OBTAINING A MARKETING AUTHORISATION
new applications for MAMarketing authorisation
Belgium as RMSReference Member State for new authorisation applications via MRPMutual Recognition Procedure – mutual recognition procedure for obtaining a marketing authorisation for medicines/DCPDecentralised procedure - decentralised procedure for obtaining a marketing authorisation for medicines
Belgium as rapporteur or co-rapporteur for applications for authorisations via NPNational procedure - national procedure for obtaining a marketing authorisation for medicines
Trend
The number of incoming files has increased by 4 %, the number of closed files by 9 %.
ASSESSORS DIVISION
MEDICINAL PRODUCTS FOR HUMAN USE
assessment reports for CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial
assessment reports for CUsCompassionate Use - the use of medicines without a marketing authorisation in compassionate use or MNPsMedical Need Program
assessment reports for a new MAMarketing authorisation
assessment reports for type II variations
Trend
An increase in the number of evaluations of CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial, CUPsCompassionate Use Program and MNPsMedical Need Program.
A reduction of the number of national type II variations.
MEDICINES FOR VETERINARY USE
assessment reports for a new MAMarketing authorisation
assessment reports for type II variations
MEDICAL DEVICES
Trend
A further increase in the number of clinical trials on medical devices.
NATIONAL INNOVATION OFFICE AND SCIENTIFIC-TECHNICAL ADVICE UNIT
NATIONAL SCIENTIFIC-TECHNICAL ADVICE (STAScientific and/or technical (such as regulatory) advice)
STAScientific and/or technical (such as regulatory) advice files for medicines for human and veterinary use submitted
IN, by procedure
OUT, by procedure
of which
of which
Joint scientific-HTAHealth Technology Assessment - multidisciplinary research that assesses different aspects of health intervention or health technology-advice
Joint scientific-HTAHealth Technology Assessment - multidisciplinary research that assesses different aspects of health intervention or health technology-advice
consultation procedures for Drug-Device Combination products by Notified Bodies
consultation procedures for Drug-Device Combination products by Notified Bodies
IN, volgens procedure
waarvan
OUT, volgens procedure
waarvan
Trend
The total number of national STAScientific and/or technical (such as regulatory) advice applications has increased by 4.6 % compared to 2017.
The number of received Joint scientific-HTAHealth Technology Assessment - multidisciplinary research that assesses different aspects of health intervention or health technology-advice requests has risen increased by 150 % compared to 2017.
QUESTIONS
PORTFOLIO MEETINGS
portfolio meetings specific for the Vaccines spearhead
portfolio meetings specific for the Early Phase Development spearhead
PROJECT INFO MEETINGS
project info meeting specific for the Oncology spearhead
EUROPEAN SCIENTIFIC ADVICE APPLICATIONS
Trend
In 2018 the number of European requests for scientific advice fell. The number of European requests for scientific advice (for human use) coordinated by Belgian SAWPScientific Advice Working Party coordinators was 17.28 % of all European advice requests.
European applications for human use – Peer reviews
European applications for veterinary use – Peer reviews
PHARMACOPEIA/APIActive Pharmaceutical Ingredient – active substance or ingredient in medicines UNIT
RAW MATERIALS FOR PHARMACY MADE AND OFFICINAL PREPARATIONS
new authorisations granted
authorisations revised
new authorisations withdrawn
THE SPEARHEADS
EARLY PHASE DEVELOPMENT
portfolio meeting in the domain Early Phase Development
INFO
Even when the European Regulation 536/2014 on clinical trials with medicines for human use will be applied, the maintenance of short timelines for the evaluation of clinical trials and certainly of early phase trials remains of great importance. A pilot project that will also include early phase trials was prepared and discussed with stakeholders in 2016 and implemented in 2017 and 2018.
Within the CGH-CMHCommission for medicines for human use attached to the FAMHP, an informal working group was set up to discuss strategic issues related to the first-in-human administration. This working group meets once or twice a year and gives ad hoc advice to the CGH-CMHCommission for medicines for human use attached to the FAMHP and other services of the FAMHPFederal Agency for Medicines and Health Products.
The royal decree on the voluntary accreditation of centers of phase I was completed in 2017. The delay for application of the European Ordinance 636/2015 is the reason for the delay in further processing.
A feasibility study for the creation of an online database to hold information on all the clinical trials in Belgium approved by the FAMHPFederal Agency for Medicines and Health Products and that have not yet been concluded, was completed. Thanks to this database, healthcare professionals and patients can consult the recruitment criteria for clinical trials in Belgium.
ONCOLOGY
for obtaining a MAMarketing authorisation for a medicine indicated for the treatment of a hepatocellular carcinoma and breast cancer (extension of the indication)
re-examination CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines
pilot projects
for ATMPsAdvanced Therapeutic Medicinal Product
Pilot projects regarding the new European Regulation 536/2014 on clinical trials with medicines for human use with the evaluation of the first CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial as part of a first national pilot project to gain experience and to coordinate the processes between all participants.
coordinator for oncological European scientific advices
portfolio meetings in the domain of oncology
project info meeting in the domain of oncology
Activities in the context of the paediatric regulation
rapporteur/peer review for paediatric investigation plans
Activities in the context of the paediatric oncology
participation in paediatric oncology strategy forums (thematic: Development of checkpoint inhibitors for use in combination therapy in paediatric patients)
participation in a conference on paediatric oncology ACCELERATE
participation in SIOP Europe – MACMEPs Against Cancer Event Celebrating 20 years of progress in paediatric haemato-oncology in Europe
INFO
The domain of oncology was represented at various national and international fora:
- International Childhood Cancer Awareness Day 2018,
- Congress Molecular Analysis for Personalised Therapy (Paris, ESMO),
- Innovation and Biomarkers in Cancer Drug Development 2018 meeting.
The collaboration with other healthcare professionals has been strengthened by, among other things the project hospitalisation at home, participation in the ComPerMed commission for oncology and haemato-oncology, in collaboration with, among others, Cancer Center, WIV-ISPScientific Institute for the Public Health and RIZIV-INAMINational Institute of Health and Disability Insurance, which is aimed at personalised medicine.
Also the collaboration with RIZIV-INAMINational Institute of Health and Disability Insurance was continued in 2018, among others via CATT-CAITCommission for advice on the temporary reimbursement of the use of a medicine (within the RIZIV-INAMI) with the preparation of the list of UMNsUnmet Medical Need – Faster access to reimbursement of molecules for which the authorisation procedure is ongoing, based on the therapeutic value, potential for access to a reimbursement outside indication.
The activities focused on the implementation and realisation of the CTRClinical Trial Regulation pilot project, on the involvement in national and European scientific advice and on CPsCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines for anti-cancer medicines, were continued in 2018.
VACCINES
CHMPCommittee for Medicinal Products for Human Use – The committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use-rapporteur for new applications MAMarketing authorisation via CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines. Permanent monitoring of 2 important public health vaccines (Dengvaxia and Shingrix). These files were closed in 2018.
CHMPCommittee for Medicinal Products for Human Use – The committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use-rapporteur for the first vaccine PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need. This file has not yet been closed.
PRACPharmacovigilance Risk Assessment Committee-co-rapporteur for new applications MAMarketing authorisation via CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines. These files were closed in 2018.
PRACPharmacovigilance Risk Assessment Committee-co-rapporteur for the first vaccine PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need. This file has not yet been closed.
portfolio meeting in the domain of vaccines
clinical trials with vaccins
INFO
Strong involvement in the review of the EMAEuropean Medicines Agency guidelines for the clinical evaluation of new vaccines and the respiratory syncytial virus.
Development of a Belgian guideline for use of “Genetically Modified Organism” in clinical trials, in cooperation with Sciensano.
The domain of vaccins spearhead was represented at various national and international fora:
- IABS narcolepsy event,
- various Flanders Vaccine symposia,
- Grand Challenges Annual Meeting (Bill and Melinda Gates Foundation – Berlin).
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