Other official information and services: www.belgium.be   

DIRECTORATE-GENERAL

PRE AUTHORISATION
competent for all activities prior to approval of the first marketing authorisation for a medicine or health product

R&DResearch and Development DIVISION (HUMAN)

CLINICAL TRIAL AUTHORISATIONS

0

CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial closed (initial)
of which

0

substantial changes or amendments closed

of which

0

according to European Directive 2001/20

0

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.

0

according to European Directive 2001/20

0

within the framework of the pilot project for preparation of the European Regulation 536/2014

100 % of the files were processed within the deadline.

95.0 %

of clinical trial applications according to the European Directive 2001/20

97.0 %

of applications for substantial amendments closed according to the European Directive 2001/20

TrendTrend

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

0
questions received via ct.rd@fagg-afmps.be

ANNUAL SAFETY REPORTS

0
DSURsDevelopment Safety Update Report - annual safety report in the framework of clinical trials

EUROPEAN PILOT PROJECT ABOUT THE VOLUNTARY HARMONISATION PROCEDURE

0
VHPsVoluntary Harmonisation Procedure on European level
*CMSConcerned Member StateRMSReference Member State

COMPASSIONATE USE AND MEDICAL NEED PROGRAMS

0
urgent notifications of medicines for use in CUCompassionate Use - the use of medicines without a marketing authorisation in compassionate use
*CUCompassionate Use - the use of medicines without a marketing authorisation in compassionate use, MNPMedical Need Program

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

CUPsCompassionate Use Program (of which 1 orphan medicine)

MNPsMedical Need Program (of which 7 orphan medicines)

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

CUPsCompassionate Use Program

MNPsMedical Need Program

substantial amendments of which

CUPsCompassionate Use Program

MNPsMedical Need Program

programs reevaluated of which

CUPsCompassionate Use Program

MNPsMedical Need Program
0 %

initial programs treated within the statutory timeframes

TrendTrend

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

with active implantable medical devices

with a class I medical device

with a class IIa medical device

with a class IIb medical device

with a class III medical device
0 %

65 % files of clinical investigation on medical devices treated within the statutory timeframes

TrendTrend

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 %.

MARKETING AUTHORISATION DIVISION (HUMAN)

APPLICATION FILES FOR OBTAINING A MARKETING AUTHORISATION

new applications via NPNational procedure - national procedure for obtaining a marketing authorisation for medicines

new applications 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

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

0 x

Belgium as RMSReference Member State

0 x
Belgium as rapporteur or co-rapporteur for new MAMarketing authorisation applications via CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines

0 x
Belgium as rapporteur or co-rapporteur for a new pharmaceutical form or strength

HOMEOPATHIC MEDICINES

new applications for MAMarketing authorisation

new applications for registration

reference files with quality data of master products or pharmaceutical forms necessary for obtaining a MAMarketing authorisation from a complex homeopathic medicine

Files closed

applications for MAMarketing authorisation

reference files

HERBAL MEDICINES

new applications for MAMarketing authorisation

variations

five-yearly renewals

0 x

Belgium as RMSReference Member State

Files closed

variations

five-yearly renewals

MEDICINES FOR VETERINARY USE DIVISION

CLINICAL TRIAL AUTHORISATIONS

CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial submitted

FILES FOR OBTAINING A MARKETING AUTHORISATION

new applications for MAMarketing authorisation

renewals

variations

files closed of which

new MAsMarketing authorisation

variations of which

variations type IA/IB

variations type II, analytical

variations type II, clinical
0 x

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

0 x

Belgium as rapporteur or co-rapporteur for applications for authorisations via NPNational procedure - national procedure for obtaining a marketing authorisation for medicines

0 x
Belgium as rapporteur or co-rapporteur for MRL-LMRMaximum limit of residue - the maximum allowed concentration of an active substance that determines the waiting time that must be respected between giving an animal a medicine and slaughtering it for consumption files

Trend

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

national and European scientific advices

assessment reports for a new MAMarketing authorisation

*CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicinesMRPMutual Recognition Procedure – mutual recognition procedure for obtaining a marketing authorisation for medicinesDCPDecentralised procedure - decentralised procedure for obtaining a marketing authorisation for medicinesNPNational procedure - national procedure for obtaining a marketing authorisation for medicines

assessment reports for type II variations

*CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines, NPNational procedure - national procedure for obtaining a marketing authorisation for medicines

Trend

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.

ICON-AFMPS-2018-BLACK-trend-down

A reduction of the number of national type II variations.

MEDICINES FOR VETERINARY USE

European scientific advices

assessment reports for a new MAMarketing authorisation

*CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicinesMRPMutual Recognition Procedure – mutual recognition procedure for obtaining a marketing authorisation for medicinesDCPDecentralised procedure - decentralised procedure for obtaining a marketing authorisation for medicinesNPNational procedure - national procedure for obtaining a marketing authorisation for medicines

assessment reports for type II variations

*CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines, NPNational procedure - national procedure for obtaining a marketing authorisation for medicines

 MEDICAL DEVICES

assessment reports for clinical trials

TrendTrend

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

files closed
"

IN, by procedure

!

OUT, by procedure

type III

type III

type II

type II

type I

type I

of which

of which

related to the Vaccines spearhead

related to the Vaccines spearhead

related to the Early Phase Development spearhead

related to the Early Phase Development spearhead

related to the Oncology spearhead

related to the Oncology spearhead

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

type III

type II

type I

waarvan

binnen het speerpunt Vaccins

binnen het speerpunt Early Phase Development

binnen het speerpunt Oncologie

Joint scientific – HTAHealth Technology Assessment - multidisciplinair onderzoek waarbij verschillende aspecten van een interventie in de gezondheidszorg worden geëvalueerd advice

consultatieprocedure voor een combinatieproduct geneesmiddel-medisch hulpmiddel door een aangemelde instantie
!

OUT, volgens procedure

type III

type II

type I

waarvan

binnen het speerpunt Vaccins

binnen het speerpunt Early Phase Development

binnen het speerpunt Oncologie

TrendTrend

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

0
questions answered of which
85.0 %
questions answered within five working days

PORTFOLIO MEETINGS

portfolio meetings in total of which

portfolio meetings specific for the Vaccines spearhead

portfolio meetings specific for the Early Phase Development spearhead

portfolio meetings specific for the Oncology spearhead

PROJECT INFO MEETINGS

project info meetings in total of which

project info meetings specific for the Vaccines spearhead

project info meetings specific for the Early Phase Development spearhead

project info meeting specific for the Oncology spearhead

EUROPEAN SCIENTIFIC ADVICE APPLICATIONS

European scientific advice applications for medicines for human use of which

specific for the Vaccines spearhead

specific for the Early Phase Development spearhead

specific for the Oncology spearhead

specific for biosimilar medicines

specific for biomarker qualifications

specific for joint scientific – HTAHealth Technology Assessment - multidisciplinary research that assesses different aspects of health intervention or health technology advice

ICON-AFMPS-2018-BLACK-trend-downTrend

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

PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need/adaptive pathways

European applications for scientific advice for veterinary use

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

applications for authorisations to be processed of which

new authorisations granted

authorisations revised

new authorisations withdrawn

15.0 %
applications for authorisations pending on company level

THE SPEARHEADS

EARLY PHASE DEVELOPMENT

applications for phase I clinical trials of which

applications for trials with a first-in-human administration
0
national STAsScientific and/or technical (such as regulatory) advice provided related with reference to early phase development
0

portfolio meeting in the domain Early Phase Development

0
project info meetings in the domain Early Phase Development
0 x
coordinator for European scientific advice with an early phase development aspect

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

0 x
rapporteur or co-rapporteur in a CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines of which

for obtaining a MAMarketing authorisation for a medicine indicated for the treatment of a hepatocellular carcinoma and breast cancer (extension of the indication)

medicines indicated for ovarian cancer (line extension and MAMarketing authorisation)

biosimilar medicines

medicine for advanced therapy initially admitted to the PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need regime

re-examination CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines

 

0 x
rapporteur or co-rapporteur for PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need files of which
0 x
rapporteur PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need file pre authorisation
0 x
co-rapporteur PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need file CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines

CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial for oncological medicines of which

pilot projects

in a paediatric population

for ATMPsAdvanced Therapeutic Medicinal Product

CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial in the context of VHPsVoluntary Harmonisation Procedure for oncological medicines

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.

0
applications for CUCompassionate Use - the use of medicines without a marketing authorisation in compassionate use
0
applications for MNPMedical Need Program
0
re-evaluations of the safety of oncological medicines
0 x

coordinator for oncological European scientific advices

national STAsScientific and/or technical (such as regulatory) advice for oncological medicines of which 1 STAScientific and/or technical (such as regulatory) advice in collaboration with RIZIV-INAMINational Institute of Health and Disability Insurance

portfolio meetings in the domain of oncology

project info meeting in the domain of oncology

Activities in the context of the paediatric regulation

0 x

rapporteur/peer review for paediatric investigation plans

0
non-clinical topic leader

Activities in the context of the paediatric oncology

0

participation in paediatric oncology strategy forums (thematic: Development of checkpoint inhibitors for use in combination therapy in paediatric patients)

0

participation in a conference on paediatric oncology ACCELERATE

0

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

0 x

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.

0 x

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.

0 x

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.

0 x

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.

0
national STAsScientific and/or technical (such as regulatory) advice
0
European scientific advices

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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