Directorate-General

PRE authorisation

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

Research and Development Division (human use)

Clinical trial authorisations

609

initial applications for clinical trials closed

443

443 in accordance with European Directive 2001/20

166

within the scope of the pilot project launched in 2017, to prepare for the new Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (Clinical trial Regulation), under which current clinical trials are received and evaluated according to the new structure, working method, and standard documents

2900

substantial changes or amendments closed

2 183

in accordance with European Directive 2001/20

717

within the scope of the new Clinical Trial Regulation pilot project

Compassionate use and medical need programmes

unmet medical need programmes submitted

15

scompassionate use cases

28

medical need programmes

unmet medical need programmes closed. 95 % were approved

reassessments of approved medical need programmes

15

compassionate use cases

26

medical need programmes

substantial amendments to unmet medical need programmes submitted

3

compassionate use cases

6

medical need programmes

urgent notifications of medicinal products for compassionate use

Questions concerning clinical trials or research and development

1183

questions concerning clinical trials or research and development received

Annual safety reports

1082

annual safety reports and an increase of 9 % compared to 2020

European pilot project on the voluntary harmonisation procedure

119

files for the European pilot project on the voluntary harmonisation procedure of which 2 with Belgium as the reference member state and 51 with Belgium as the concerned member state

Clinical investigations with medical devices

clinical investigations with medical devices

31

clinical investigations with medical devices in accordance with European Directives 93/42 and 90/385

8

with a class I medical device

8

with a class IIa medical device

4

with a class IIb medical device

11

with a class III medical device

clinical investigations with medical devices in accordance with the new Regulation (EU) 2017/745

2

with a class I medical device

10

with a class IIa medical device

5

with a class IIb medical device

10

with a class III medical device

performance studies with in vitro diagnostics

COVID-19

COVID-19 related activities

Marketing Authorisation Division (human use)

Files for obtaining marketing authorisation

new applications for a marketing authorisation via the national procedure

169

new applications for a marketing authorisation via the mutual recognition procedure or decentralised procedure

437

variations for which Belgium was rapporteur or co-rapporteur via the centralised procedure

renewals for which Belgium was rapporteur or co-rapporteur via the centralised procedure

565

files closed

11

new marketing authorisations via the national procedure (81.8 % closed within the statutory periods)

154

new marketing authorisations via the mutual recognition procedure or decentralised procedure (85.1 % closed within the statutory periods)

390

variations for which Belgium was rapporteur or co-rapporteur via the centralised procedure (95.3 % closed within the statutory periods)

10

renewals for which Belgium was rapporteur or co-rapporteur via the centralised procedure (90 % closed within the statutory periods)

files with
Belgium as reference Member State

files with Belgium as rapporteur or co-rapporteur for new marketing authorisations via the centralised procedure

Trend

The number of files IN via the centralised procedure continues to increase.

The number of files IN/OUT via the mutual recognition procedure and the decentralised procedure has increased slightly.

COVID-19

The Centralised Procedure Entity has had a very busy year due to the follow-up of COVID-19 files, relating to both vaccines and treatments.

In addition to files in which it acted as rapporteur and co-rapporteur, Belgium was involved in two files of multinational evaluation teams for the quality component.

Trend

The periods for closing files via the mutual recognition procedure and the decentralised procedure have become slightly longer. This is due to the closure of old files.

Homeopathic medicines

new applications for a marketing authorisation

new applications for registration

variations

five-yearly renewals

reference files with quality data on master products or pharmaceutical forms necessary for obtaining a marketing authorisation for a complex homeopathic medicine

closed files (96.93 % closed within the statutory periods)

1 application fora marketing authorisation(100 % closed within the statutory periods)
22 applications for registration(91 % closed within the statutory periods)
26 variations(96.15 % closed within the statutory periods)
2 five-yearly renewals(100 % closed within the statutory periods)
47 reference files(100 % closed within the statutory periods)

Trend

The statutory periods were respected more often than in 2020.

COVID-19

Some files could not yet be evaluated due to the impact of the COVID-19 health crisis.

Herbal medicines

variations

five-yearly renewals

(89 % closed within the statutory periods)

77 variations
4 five-yearly renewals

Trend

In 2021, there was a significant increase in the number of closed files.

Medicines for Veterinary Use Division

Clinical trial authorisations

applications for clinical trials

Files for obtaining marketing authorisation

new applications for a marketing authorisation

renewals

780

variations

Procedures for marketing authorisations or variations

827

files closed

60

new marketing authorisations

74

renewals

680

variations

545

type IA/IB variations

24

type-II variations, clinical

109

type-II variations, analytical

dossiers with Belgium as reference member state of new authorisation applications via the mutual recognition procedure or decentralised procedure

Due to the heavy workload resulting from the implementation of the new Regulation (EU) 2019/6 on medicinal product for veterinary use, among other reasons, no new applications for authorisation with Belgium as the reference member state were initiated in 2021.

dossiers with Belgium as rapporteur or co-rapporteur for authorisation applications via the national procedure

dossiers with Belgium as rapporteur or co-rapporteur of a European scientific advice request

dossiers with Belgium as rapporteur or co-rapporteur of application for Minor Use Minor Species classification

Trend

<p style=”padding-left: 40px;”>The total number of files received increased by 2 %.</p>

Trend

In 2021, the number of new applications for authorisation at European level decreased.

Assessors Division

Medicinal products for human use

382

assessment reports for initial applications for clinical trials

assessment reports for compassionate use or medical need programmes

139

national and European scientific advice files

assessment reports for new marketing authorisations

via the centralised procedure as rapporteur or co-rapporteur

via the mutual recognition procedure or centralised procedure

via the national procedure

201

assessment reports for type-II variations

via the centralised procedure

120

via the national procedure

Medicinal products for veterinary use

European scientific advice documents

evaluation reports for new marketing authorisations

via the centralised procedure as rapporteur or co-rapporteur

via the mutual recognition procedure or centralised procedure

via the national procedure

(this procedure is rarely used)

evaluation reports for type-II variations

via the centralised procedure

via the national procedure

Medical devices

evaluation reports for applications for clinical trials

New

The assessors of medical devices had to adapt their processes in 2021 as a result of the implementation of the new Regulation (EU) 2017/745 on medical devices. The assessors also made a significant contribution to the preparation of the new European legislation with Regulation (EU) 536/2014 on clinical trials on medicinal products for human use, Regulation (EU) 2019/6 on medicinal products for veterinary use, and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices, which were implemented in early 2022. There were also a great many scientific innovations in 2021, which needed to be followed up.

Trend

The complexity of the files being evaluated is increasing every year: more complex medicinal products, production methods, designs of clinical trials, and data analysis methods. In addition, the assessors are also being presented with increasing numbers of questions, many of which concern non-availability (questions about the essential nature of and alternatives for medicinal products).

COVID-19

The coronavirus pandemic also had a significant impact on the operations of the Assessors Division in 2021. Applications for clinical trials and national scientific advice for COVID-19 vaccines and therapies are still being processed within shortened timelines. The assessors played an active role in evaluating and monitoring the market authorisation of these medicinal products, both at national and European level, working in close consultation with stakeholders and policymakers. The Assessors Division also handled parliamentary and press questions, as well as questions from citizens.

National Innovation Office and Scientific-Technical Advice Unit

National scientific-technical advice

closed scientific-technical advice files for medicinal products for human and veterinary use

17

type-I

13

type-II

26

type-III

15 related to the spearhead VACCINES

6 medicinal products to treat COVID-19

2 for medicinal products based on genetically modified organisms. Collaboration with the Biosafety and Biotechnology service of Sciensano.

5 for vaccines. Collaboration with the Quality of vaccines and blood products service of Sciensano.

7 for simultaneous national scientific advice. In collaboration with a second medicinal products authority within the scope of the European pilot project, which was extended in 2021 by the Heads of Medicines Agencies (HMA).

3 for pilot projects with patients. In addition to the advice of the FAMHP experts, the advice of one or more specific patient organisations was incorporated in the recommendations of each project.

closed scientific-technical advice files for medicinal products for human and veterinary use

New

The FAMHP is actively involved in the European pilot project for repurposing authorised medicines for new therapeutic indications. The project was launched at the end of 2021 by the expert group Safe and Timely Access to Medicines for Patients (STAMP) of the European Commission. In this context, the FAMHP is supporting non-profit organisations and academic centres by providing scientific-technical and regulatory advice in the research into the repurposing of existing medicines for new indications.

In order to align the development of innovative drugs more closely to the needs and requests of patients, a pilot project was relaunched to issue advice on the clinical development of new medicinal products. The advice is prepared in consultation with specific patient associations. In 2021, three requests for advice were processed as part of this pilot project.

Trend

The total number of national scientific-technical advice requests received fell slightly (7 %) compared to 2020.

Fewer scientific-technical advice requests were submitted on issues relating to genetically modified organisms in 2021.

Trend

The number of national scientific-technical advice requests relating to vaccines reached a peak in 2020 due to the coronavirus health crisis. The FAMHP received fewer scientific-technical advice requests relating to vaccines in 2021. However, they still account for more than 25 % of the total number of scientific-technical advice requests. This trend once again highlights the importance of the expertise of the FAMHP on vaccines.

COVID-19

Six requests for advice were submitted for medicinal products against COVID-19.

The accelerated scientific-technical advice procedure was further applied in 2021 to enable the accelerated processing of requests for advice on medicinal products to treat COVID-19. The Law of 8 February 2022 providing the legal framework for the accelerated scientific-technical advice procedure was drafted and submitted for approval.

Questions

195

questions and answers

Trend

The National Innovation Office of the FAMHP supports developers of new medicines by answering general and regulatory questions about the various research and development aspects of medicines and therapies. In 2021, the number of questions received rose by 56 % compared with 2020. Ninety per cent of questions were answered within five working days.

Portfolio meetings

portfolio meetings

Trend

ollowing a temporary suspension due to the COVID-19 health crisis, portfolio meetings were restarted in the fourth quarter of 2021.

Project information meetings

project information meetings with local developers on a planned project for medicine development

Trend

Project information meetings were restarted in 2021 for projects not related to COVID-19.

Helsinki procedure

Helsinki procedure providing input on the regulatory status and/or classification of a borderline product to the Medical Device Coordination Group of the European Commission

European requests for scientific advice

176

European requests for scientific advice for medicinal products for human use

for the spearhead VACCINES

for medicinal products to treat COVID-19 (of which eight via the accelerated procedure)

for priority medicinal products

for biomarkers

European request for scientific advice for medicinal products for veterinary use

Pharmacopeia/Raw Materials Unit

Authorisations for raw materials used in magistral and officinal preparations

New

All results for 2021 are similar to those of 2020, a year which was also dominated by the COVID-19 health crisis.

However, the system for granting authorisations has been adjusted so that no applications from companies are currently being processed.