Other government information and services

Directorate General

PRE authorisation

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

Divisions

Research and Development Division (human use)

Clinical trial authorisations

0
CTAs closed (initial applications) of which

469

in accordance with European Directive 2001/20

79

79 within the framework of the CTR pilot project in preparation for European

0
substantial amendments or amendments closed of which

2 768

in accordance with European Directive 2001/20

136

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

0 %
of clinical trial applications closed in accordance with European Directive 2001/20

of the 79 initial dossiers closed in 2019 within the framework of the CTR pilot project, 68 dossiers were processed within the timelines envisaged in the procedure

0 %
of applications for substantial amendments closed in accordance with European Directive 2001/20

of the 136 substantial amendments closed in 2019 within the framework of the CTR pilot project, 131 dossiers were processed within the timelines envisaged in the procedure

Trend

Increase in the number of requests for substantial amendments owing to Brexit and due to the increased complexity and longer duration of clinical trials.

The number of initial requests submitted within the framework of the CTR pilot project that began in May 2017 has gradually increased over the course of 2019 to a general percentage of 15.8% of the total number of initial CTAs.

In December 2019, 27.5% of the initial CTAs were submitted in accordance the procedure for the CTR pilot project.

Questions concerning clinical trials or research and development

0
questions received via ct.rd@fagg.be

Annual safety reports

0
DSUR’s

European pilot project on the voluntary harmonisation procedure

RMS, CMS

Compassionate use and medical need programmes

0
UMN programmes submitted, of which 10 CUP and 20 MNP

These programmes would enable 2,098 patients to be treated.

10

substantial amendments, of which 2 CUP and 8 MNP

33

programs re-evaluated, of which 18 CUP and 15 MNP

97% initial programmes processed within the statutory timeframes

Trend

The number of UMN programmes has risen by 10% compared to 2018. There were fewer initial submissions, but more amendments and re-evaluations have been processed.

Therapeutic area for new applications

0

Clinical investigations with medical devices of which

5

with active implantable medical devices

4

with a class I medical device

13

with a class IIa medical device

4

with a class IIb medical device

14

with a class III medical device

2019 saw the closure of 44 clinical investigation files, with 95% within the legal period.

Marketing Authorisation Division (human use)

Files for obtaining marketing authorisation

0
new applications via NP
  • 163 new applications via MRP or DCP
  • 352 variations for which Belgium was rapporteur or co-rapporteur via CP
  • 7 renewals for which Belgium was rapporteur or co-rapporteur via CP
0
files closed, of which
  • 2 new MA’s via NP
  • 138 new MA’s via MRP or DCP
  • 303 variations for which Belgium was rapporteur or co-rapporteur via CP
  • 8 renewals for which Belgium was rapporteur or co-rapporteur via CP
0
Belgium as RMS

Belgium as rapporteur or co-rapporteur for new MA applications via CP

Trend

This Division continues to achieve the objective for the number of (co)-rapporteurships and sending out evaluation reports in a timely manner.

The total volume of files is rising. This rise can be partially explained by British files assigned to the FAMHP due to Brexit. The monitoring of five additional medicines was assigned to the FAMHP as rapporteur and eight more as co-rapporteur.

In 2019, the FAMHP was designated PRIME rapporteur for two new medicines (a vaccine + an ATMP).

The number of submissions via MRP and DCP remained stable. The closure periods were less easy to monitor owing to a temporary lack of staff. This should stabilise in early 2020.

Belgium was only RMS on two occasions. This is a sharp drop compared to previous years. One possible cause of this is the review of the contributions to be paid.

New

Ebola vaccine

Belgium is rapporteur for the first Ebola vaccine. The Belgian Vaccines team has been working on this challenging file for over three years. This is taking place in close collaboration with the applicant, external experts, the EMA and the WHO and with the aid of the full regulatory “toolbox”.

“This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s Executive Director. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.”

EMA’s positive opinion for the first vaccine against Ebola virus disease demonstrates the scientific expertise in the EU that can be mobilised to reduce the impact of deadly diseases like Ebola,” said Harald Enzmann, Chair of the CHMP.

The first ATMP HE was submitted and granted in 2019. The legal periods mentioned in the Royal Decree of 8 January 2017 have been respected here.

Homeopathic medicines

0
new applications for MA
  • 10 new applications for MA
  • 30 new applications for registration
  • 27 reference files with quality data on master products or pharmaceutical forms necessary for obtaining a MA for a complex homeopathic medicine
0
files closed
  • 18 applications for MA
  • 25 applications for registration
  • 19 reference files

Trend

The number of MA’s issued rose considerably in 2019.

Simplified registrations were also issued for the first time.

Herbal medicines

Files closed

0
Variations
0
five-yearly renewals

Trend

Significantly more variations were submitted and processed for herbal medicines in 2019 than in 2018.

The number of new MA’s has fallen slightly.

New

The Commission for Homeopathic Medicines for Human and Veterinary use and the Commission for Herbal Medicines for Human Use have been reformed.

The reduction in the effective number of members results in greater flexibility, simplifies interactions, both internally and with external stakeholders, and raises efficiency.

Medicines for Veterinary Use Division

Clinical trial authorisations

0
CTAs submitted

Files for obtaining marketing authorisation

0
new applications for MA via MRP, DCP and NP
0
renewals via MRP, DCP and NP
0
variations via MRP, DCP and NP
0
files closed of which

93

new MA’s

1149

variations of which

1037

type IA/IB variations

18

type II variations, clinical

94

type II variations, analytical

0 x
Belgium as rapporteur or co-rapporteur for MA applications via NP
0 x
Belgium as rapporteur or co-rapporteur for post-marketing procedures via CP
0 x
Belgium as RMS for post-marketing procedures via MRP/DCP

Trend

The number of files closed has increased by 66% and the number of incoming files by 9%.

Assessors Division

Medicines for human use

0
assessment reports for CTA's
0
assessment reports for CU's or MNP's
0
national and European scientific advisories
0
assessment reports for a new MA

CP, MRP, DCP, NP

0
assessment reports for type II variations

CP, NP

Medicines for veterinary use

0
European scientific advisory
0
assessment reports for a new MA

CP, MRP, DCP, NP

0
assessment reports for type II variations

CP, NP

Medical Devices

0
assessment reports for clinical trials

Trend

The Assessors Division is responsible for the assessment of scientific data that supports the applications submitted to other Divisions of the FAMHP.

The number of assessment reports drawn up in 2019 is in line with those for 2018. The pre-set goals have been achieved or even exceeded.

Particular points for consideration for 2019.

  • The rise in the number of clinical trials within the CTR pilot project and the development of the specific expertise needed for the assessment of these.
  • Our role as European CHMP rapporteur for the MA for innovative medicines, primarily in the fields of oncology, endocrinology and vaccines.
  • The processing of the first request for a hospital exemption for an ATMP (ATMP HE).
  • A sharp rise in questions on the essential character and potential alternatives to medicines with temporary unavailability.
  • A sharp fall in the number of national type II variations waiting for a clinical evaluation.

National Innovation Office and Scientific-Technical Advice Unit

National scientific-technical advice

0
files closed
0
STA files for medicines for human and veterinary use submitted

IN, by procedure

20

type III

5

type II

7

type I of which

  • 13 related to the VACCINES spearhead
  • 25 related to the EARLY PHASE DEVELOPMENT spearhead
  • 3 related to the ONCOLOGY spearhead
  • 3 Joint Scientific Advice with Sciensano (Biosafety & Biotechnology Service) for medicines based on genetically modified organisms
  • 1 consultation procedure for Drug-Device Combination products by Notified Bodies
  • 5 Helsinki procedures whereby the National Innovation Office, in collaboration with the DG POST authorisation, provided input to the MDCG Borderline & Classification Working Group on the regulatory status/classification of a borderline product.

Trend

The major quantity of STA requests coming under the FAMHP’s spearheads (mainly for EARLY PHASE DEVELOPMENT and VACCINS) confirms the importance of the synergy with these fields of expertise at the FAMHP.

The total number of national STA applications received fell by 29% compared to 2018. This is presumably the result of the higher STA fees on the one hand, and the (thus far) low uptake of the new reduced/zero STA fee concepts launched in mid-2019.

New

The concept of 75% STA fee reduction was launched for STA requests submitted by SMBs, universities, recognised hospitals, foundations for the public good and authorities regulated by public law. In doing so, the FAMHP is aiming to make STA service provision more accessible to these types of innovators.

The concept of the zero STA fee was launched for STA requests from innovators for a planned clinical trial whereby the applicant commits to the submission of a clinical trial request in accordance with the CTR pilot project within two years of processing their national STA request.

Two zero STA fee requests (type III) and three STA fee reduction requests (type III) were submitted in 2019.

Three STA files were processed as part of the patient engagement pilot project in collaboration with patient experts and organisations in order to raise the quality of the advice provided by the FAMHP through early input from the patients’ perspective.

Two STA files for vaccines were successfully processed concurrently with a second medicines authority in the EU (the Paul-Ehrlich Institute in Germany). This took place as part of a pilot project for the implementation of the Simultaneous National Scientific Advice (SNSA concept), which will formally commence in 2020.

0
Questions

were answered, 88.5% of which within five working days. This is a rise of 12% compared to 2018.

0
Portfolio meetings

of which

3

portfolio meetings specific to the VACCINES spearhead

8

portfolio meeting specific (fully or partially) to the EARLY PHASE DEVELOPMENT spearhead

2

portfolio meeting specific (partially) to the ONCOLOGY spearhead

Trend

The number of portfolio meetings rose by 233%. This demonstrates the increasing importance of consultation at an early phase, whereby pharmaceutical companies can propose their development programmes in an informal manner and discuss emerging scientific evolutions and regulatory challenges at an early phase, prior to the formal submission of specific files.

0
Project information meetings

with local innovators concerning a planned medicine development project in total of which

2

project information meetings specific to the VACCINES spearhead

4

project information meetings specific to the EARLY PHASE DEVELOPMENT spearhead

1

project information meeting specific to the ONCOLOGY spearhead

Trend

The number of project information meetings rose by 133%. This demonstrates the increasing importance of consultation at an early phase, whereby academic research groups and SMBs can request early regulatory guidance in an informal manner, prior to a planned development programme. This guidance can help them identify critical points more quickly for which a formal STA request can then be submitted, for example.

European requests for scientific advice

0
European applications for STA for medicines for human use of which

7

for the VACCINES spearhead

14

for the EARLY PHASE DEVELOPMENT spearhead

34

for the ONCOLOGY spearhead

5

for PRIME eligibility requests

3

for biomarker qualifications

2

for joint scientific – HTA advice

0
European applications for STA for medicines for veterinary use

Trend

The number of SAWP requests processed rose by 38% in 2019.

The number of European requests for scientific advice (for medicines for human use) co-ordinated by Belgian SAWP co-ordinators amounted to 22.3% of all European advice requests.

This means Belgium is making a significant contribution to the SAWP activities at a European level.

The number of European requests for scientific advice (for medicines for veterinary use) remained the same.

Pharmacopoeia/Raw Materials Unit

Raw materials used in compounded and officinal preparations

0
new applications for authorisations to be processed of which

184

new authorisations granted

80

authorisations being processed at the firms

12

authorisations being processed at the FAMHP

0
reviews to be processed of which

646

reviews granted

2

reviews being processed at the firms

Spearheads

ONCOLOGY

0 x
rapporteur or co-rapporteur in a CP of which

3

for obtaining an MA for a medicine for treating pancreatic cancer, ovarian cancer and prostate cancer (expansion of indication; these files have not yet been closed)

3

biosimilar medicines

0
CTA's for oncological medicines of which

11

in a paediatric population

12

for ATMP’s

20

CTA’s as part of VHP’s

Some of these came under the pilot projects in the context of the new European Regulation 536/2014 on clinical trials with medicines for human use. These pilot projects allow experienced to be gained and the co-ordination of processes between all participants.

0
applications for CUP

(4 new + 2 amendments)

0
applications for MNP

(9 new + 5 amendments)

0
re-evaluations of the safety of oncological medicines
0 x
co-ordinator for oncological European scientific advisories
0
national STAs for oncological medicines
0
portfolio meetings in the field of Oncology
0
project information meeting in the field of Oncology

Activities in the context of paediatric legislation

0 x
rapporteur/peer review for paediatric investigation plans

Activities in paediatric oncology

1

participation in paediatric oncology strategy forums (thematic: acute myeloid leukaemia in paediatric patients)

1

participation in SIOP Europe Annual Meeting

1

participation in SIOP Europe – International Childhood Cancer Awareness Day

The ONCOLOGY spearhead was represented at various national and international forums

  • 21st Post-ASH meeting (Belgian Haematology Society)
  • 22nd Post-ASCO Meeting
  • 21st Annual Meeting of the Belgian Society of Medical Oncology
  • 44th ESMO congress
  • 5th EORTC Quality of Life Cancer Clinical Trials Conference
  • Presentation at EHA congress: “Regulating personalised medicine trials: a regulator perspective”
  • Presentation at International Oncology Leadership Conference (IOLC)
  • Presentation at Postgraduate course at AZ KLINA: “Role of the FAMHP in the EU regulatory environment: focus on the activities during the lifecycle of medicinal products”
  • Conference on “Integrating genomics into personalised healthcare”
  • Conference on “Efficiency and sustainability in innovative patient-centred cancer care”
  • Stakeholder workshop Forum Citoyen ‘My DNA, everybody’s business? Mon ADN, tous concernés?’
  • CDDF workshop on patient involvement

The collaboration with other healthcare professionals has been strengthened by the hospitalisation at home project and the participation in the ComPerMed commission for oncology and haemato-oncology, in collaboration with, among others, the Cancer Centre, the SIPH and the NIHDI, which is aimed at personalised medicine.

The collaboration with the NIHDI also continued in 2019, via the CATT among others, with the preparation of the list of UMNs.

The activities focusing on the implementation and realisation of the CTR pilot project, on the involvement in national and European scientific advice and on CPs for anti-cancer medicines, continued in 2019.

VACCINES

0 x
CHMP rapporteur for vaccine PRIME

of which 1 file closed

0 x
CHMP co-rapporteur/peer reviewer

these files have not yet been closed

0 x
PRAC rapporteur

these files have not yet been closed

0 x
PRAC co-rapporteur for vaccine PRIME

of which 1 file closed

0
national STA's
0
European scientific advisories
0
portfolio meetings in the VACCINES spearhead
0 x
clinical trials with prophylactic vaccines

Several activities for the VACCINES spearhead

Publication of the article “Clinical trials with GMO-containing vaccines in Europe: status and regulatory framework” in the journal Vaccin.

Organisation of the vaccination symposium on 6 December 2019.

New

In 2019, the guideline on “Belgian Regulations on the use of genetically modified organisms in a clinical trial with GMOs” for researchers and sponsors of clinical trials was published in collaboration with Sciensano.

Share via
Copy link
Powered by Social Snap

Fagg

https://annualreport.fagg-afmps.be