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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)

0

substantial changes or amendments closed

96.0 %

of clinical trial applications closed within the statutory timeframes

96.0 %

of applications for substantial amendments closed within the statutory timeframes

TrendTrend

An increasing trend of substantial changes compared to previous years because of the increasing complexity and the longer duration of clinical trials

niew-icon-glitteNew

In preparation for the new European clinical regulation 536/2014 on clinical trials with medicinal products for human use, a pilot project was started in May 2017 whereby current clinical trials are received and evaluated according to the new structure, working methods and standard documents.

9 new applications for clinical trials were treated in this way in 2017, of which 7 were approved in 2017.

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

Therapeutic area of new applications

CLINICAL INVESTIGATIONS ON MEDICAL DEVICES

clinical investigations on 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

TrendTrend

A 68 % increase of clinical investigation on medical devices.

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

TrendTrend

The handling time of NPsNational procedure - national procedure for obtaining a marketing authorisation for medicines are respecting more and more the statutory timeframes.

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

variations

five-yearly renewals

new applications based on a monograph

Files closed

variations

five-yearly renewals

new applications based on a monograph

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

renewals

variations

files closed of which

new MAsMarketing authorisation

renewals

variations of which

variations type IA/IB

variations type II, analytical

variations type II, clinical

0 x

Belgium as RMSReference Member State

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

A 35 % increase in the number of closed MRPMutual Recognition Procedure – mutual recognition procedure for obtaining a marketing authorisation for medicines files.

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

TrendTrend

Further increase in the number of national and European scientific advice that the FAMHPFederal Agency for Medicines and Health Products plays a role in.

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

An increase in the number of clinical trials on medical devices.

NATIONAL INNOVATION OFFICE & SCIENTIFIC-TECHNICAL ADVICE UNIT

NATIONAL SCIENTIFIC-TECHNICAL ADVICE

STAScientific and/or technical (such as regulatory) advice files for medicines for human use submitted of which

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

consultation procedure 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

A 22,8 % increase in the number of national STAScientific and/or technical (such as regulatory) advice applications.

QUESTIONS

0

questions answered of which

87.0 %

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 meetings specific for the Oncology spearhead

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The concept project info meetings was launched in June 2017 to support innovative medicines research in an early stage. These meetings are very positively regarded by Belgian SMEsSmall and medium-sized enterprise and academic researchers.

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

TrendTrend

A 10,5 % increase in the number of European applications for scientific advice (for human use) for which Belgium was one of the coordinators.

European STAScientific and/or technical (such as regulatory) advice 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

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

0.02 %

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 meetings 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

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.

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. At the 2 meetings in 2017, proposals were made about strategic options and retrospective advice on a number of CTAsClinical Trial Application - file for obtaining an authorisation for a clinical trial.

Under the guidance of the FAMHPFederal Agency for Medicines and Health Products, a European training program was developed for non-clinical and clinical assessors who assess early phase trials. In March 2017 there was a two-day training for assessors from the national competent authorities.

The Royal Decree on the voluntary accreditation of centers of phase I was completed with the interested parties and is ready for signature.

The FAMHPFederal Agency for Medicines and Health Products was actively involved in the revision of the European document Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This is an extension of the previous directive that was finalised in 2017.

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 (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

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

0 x

rapporteur CPCentralised procedure - centralised procedure for obtaining a marketing authorisation for medicines for biosimilar medicines

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

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

Participation in a pilot projects consultation regarding the new European Regulation 536/2014 on clinical trials with medicines for human use with the evaluation of the first CTAClinical 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, some of which for biosimilar medicines and quality 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 Oncology

project info meetings in the domain Oncology

Activities in the context of the paediatric regulation

0 x

rapporteur for paediatric investigation plans

0

peer review for paediatric investigation plans

0

non-clinical topic leader

Activities in the context of the paediatric oncology

0

participations in pediatric oncology strategy forums (thematic: ALKAnaplastic lymphoma kinase rearrangement inhibitors and mature B-cell malignancies)

0

participation in a conference on pediatric oncology ACCELERATE

Active collaboration on the EMAEuropean Medicines Agency project to evaluate the impact and usefulness of youth animal studies for the development of pediatric medicines (published on the EMAEuropean Medicines Agency website in 2017)

The Oncology spearhead was represented at various national and international fora

  • International Childhood Cancer Awareness Day 2017
  • Post-ASH meeting (Belgian Haematology Society)
  • 20th Post-ASCO Meeting
  • 19th Annual Meeting of the Belgian Society of Medical Oncology
  • Meet the oncology expert seminars (Bordet Institute)
  • Congress Molecular Analysis for Personalised Therapy (Zurich, ESMO)
  • Conference Quality of Life and Cancer Clinical Trials (Brussels, EORTC)
  • Workshop Site and histology-independent indications in oncology (EMA)

The collaboration with other healthcare professionals has been strengthened among other things

  • the project hospitalisation at home of 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
  • participation at the symposium Introduction of the Next-Generation Sequencing technology in (haemato-)oncology in the Belgian healthcare system in November 2017

Also the collaboration with RIZIV-INAMINational Institute of Health and Disability Insurance was continued through, 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'' for 2018.

The activities with a focus 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, will be continued in 2018.

VACCINES

0 x

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; these files have not yet been closed

0 x

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 meetings in the domain Vaccines

project info meetings in the domain Vaccines

Strong involvement in the review of the EMAEuropean Medicines Agency guidelines for the clinical evaluation of new vaccines and the respiratory syncytial virus

First VACCIN symposium of the FAMHPFederal Agency for Medicines and Health Products on the current Belgian and European regulatory initiatives to support the development of vaccines

1 mapping out the main actors involved in research and development activities in Belgium

1 study/publication on recruitment barriers in prophylactic vaccine studies in Belgium

Active participation in conferences and symposiums: International Neonatal and Maternal Immunisation Symposiums, Immunity for Health, Flanders vaccine event

The FAMHPFederal Agency for Medicines and Health Products also records a stable number of clinical trials with vaccines in Belgium

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