Directorate General

PRE authorisation

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

Research and Development Division (human use)

Clinical trial authorisations

525
initial applications for clinical trials closed
2926
substantial changes or amendments closed

Compassionate use and medical need programmes

31
unmet medical need programmes submitted
30
unmet medical need programmes closed
51
reassessments of approved medical need programmes
12
substantial amendments to unmet medical need programmes submitted
63
urgent notifications of medicinal products for compassionate use

Questions concerning clinical trials or research and development

1021
questions concerning clinical trials or research and development received

Annual safety reports

1090
annual safety reports and an increase of 9 % compared to 2020

Clinical investigations with medical devices

125
16
14

New

Oa 31 January 2022, the new regulation for clinical trials (Clinical Trials Regulation, CTR), Regulation 536/2014, came into force with the aim of simplifying the administration for applications for clinical trials of medicinal products for human use and harmonising legislation within the European Union.

An important step to prepare sponsors for the new regulation was the CTR pilot project (in collaboration with the ethics committees). The aim was to gain experience and align processes between all participants. The project was stopped for initial applications at the end of 2021, although other applications (such as for substantial changes) remained possible.

The year 2022 was a tipping point year for the CTR project due to different transition periods and procedures. A flexible approach by the Research and Development Division and the Assessors Division was needed to provide optimal support to the sponsors. Implementing the new regulation and rolling out the new CTIS database proved to be tough challenges.

The submission of initial clinical trials became mandatory via CTIS early 2023. We expect a sharp increase in the number of files within the CTR. That will be the next challenge for our division.

Marketing Authorisation Division (human use)

Files for obtaining marketing authorisation

2
new applications for a marketing authorisation via the national procedure
170
new applications for a marketing authorisation via the mutual recognition procedure or decentralised procedure
416
variations for which Belgium was rapporteur or co-rapporteur via the centralised procedure
7
renewals for which Belgium was rapporteur or co-rapporteur via the centralised procedure
632
files closed
4
files with
Belgium as reference Member State
4
files with Belgium as rapporteur or co-rapporteur for new marketing authorisations via the centralised procedure

Trend

The team responsible for authorisations under the centralised procedure was under pressure in 2022 due to the different procedures for COVID-19 medicinal products.

Therefore, between European Member States, more use was made of each other’s expertise in the form of multinational assessment teams when evaluating new applications. Belgium took the role of rapporteur or co-rapporteur in four files and was part of a multinational assessment team for the quality item of three other files.

Homeopathic medicines

9
new applications for a marketing authorisation
46
new applications for registration
34
variations
15
five-yearly renewals
26
reference files with quality data on master products or pharmaceutical forms necessary for obtaining a marketing authorisation for a complex homeopathic medicine
93
files closed

Herbal medicines

4
new applications for a marketing authorisation or a registration
35
variations
2
five-yearly renewals
35
files closed

Trend

There are still relatively few new applications for a marketing authorisation or registration of herbal medicines. The number of variations decreased in 2022 compared to 2021.

The number of files closed is lower than in 2021, but this is also due to the decrease in the number of new files.

Medicines for Veterinary Use Division

918
files closed

Clinical trial authorisations

4
applications for clinical trials

Files for obtaining marketing authorisation

46
new applications for a marketing authorisation

Variations

356
variations for which an evaluation is required
504
variations for which no evaluation is required

Trend

Following the entry into force of the new Regulation (EU) 2019/6, few changes were submitted in the first half of 2022 that did not require assessment. This is because marketing authorisation holders had to familiarise themselves with the new Union Product Database (UPD) and the new submission system. This system had a difficult start and was regularly unavailable. In the third quarter of 2022, we saw a sharp increase in the number of files submitted. This trend continued in the fourth quarter of 2022. The number of files submitted on a monthly basis increased fivefold compared to the corresponding months in 2021 and the corresponding type of changes (Type IA and IB changes). The number of changes to be assessed has tripled compared to 2021 and the corresponding type of changes (type II-changes). The change in regulation and the increase in the number of files submitted lead to an increase in processing time.

Procedures for marketing authorisations or variations

1
new authorisation application via the mutual recognition procedure or the decentralised procedure file with Belgium as reference Member State
0
authorisation application via the national procedure with Belgium
6
applications for European scientific advice with Belgium as rapporteur or co-rapporteur
5
files with Belgium as rapporteur or co-rapporteur for a new medicine product or vaccine

New

The entry into force of Regulation (EU) 2019/6 and working with the new database (UPD) from 28 January 2022 had a significant impact on the operation of the Medicines for Veterinary Use Division in terms of staff training, revision of procedures and file management.

Assessors Division

Medicinal products for human use

280
assessment reports for initial applications for clinical trials
31
assessment reports for compassionate use or medical need programmes
101
national and European scientific advice files
57
assessment reports for new marketing authorisations
239
assessment reports for type-II variations
204
questions on essential medicines and alternatives in case of unavailability

Trend

In 2022, the number of questions on the essentiality of medicines and possible alternatives in case of unavailability increased.

Medicinal products for veterinary use

6
European scientific advice documents
38
evaluation reports for new marketing authorisations
74
evaluation reports for type II-variations

Medical Devices

53
evaluation reports for applications for clinical trials

New

On 31 January 2022, the new Clinical Trials Regulation (CTR) came into force. ​Together with the Research and Development Division, the Assessors Division played an important role in the preparation and implementation of the new regulation.

To prepare for the new legislation as thoroughly as possible, the necessary templates were first drawn up and internal processes were harmonised.
This included fortnightly meetings with the Assessors Division and the Research and Development Division (human use) to follow up on the implementation of the CTR, deal with specific files and resolve any issues.

Due to transition periods and various (new) procedures, the Assessors Division faced many challenges in 2022. Nevertheless, clinical trial sponsors were optimally prepared and guided for the new regulation and procedures, such as the Clinical Trials Information System (CTIS) that became the gateway for sponsors and regulatory authorities to submit applications for clinical trials in accordance with Regulation 536/2014.

All involved staff in the Assessors Division have shown the necessary professionalism and flexibility to meet these new challenges in 2022, in collaboration with our internal stakeholders. Early 2023, initial applications for clinical trials can only be submitted through CTIS which will ensure an increasing number of files. This will be the new challenge for the service.

National Innovation Office and Scientific-Technical Advice Unit

National scientific-technical advice

43
national applications for scientific-technical advice for medicinal products for human and veterinary use have been submitted
39
national applications for scientific-technical advice for medicinal products for human and veterinary use have been closed

Simultaneous national scientific advice

4
submitted and closed applications for simultaneous national scientific advice (SNSA) in collaboration with other national medicines authorities in the context of the European SNSA pilot project of the EU Innovation Offices Network (EU IN)

Questions

220
questions and answers
(including on existing regulation and guidelines, research and development, innovation and the FAMHP's services)

Meetings

5
portfolio meetings
6
project information meetings with local developers on a planned project for drug development

Consultation procedure for medical devices with a medicinal product as an integrated part of the medical device

1
consultation procedure submitted by a registered authority for medical devices with a medicinal product as an integrated part of the medical device

TSE consultation procedure

25
TSE consultation procedures for medical devices using animal tissues for their production that may cause Transmissible Spongiform Encephalopathies (TSE)

European requests for scientific advice

136
European applications for scientific advice for medicinal products for human use
4
European applications for scientific advice for veterinary medicinal products

New

Pilot project on patient involvement in national scientific-technical advice

In 2022, six national scientific advice files have been handled in close collaboration with representatives of a disease-specific patient organisation as part of the FAMHP’s pilot project on patient involvement in national scientific-technical advice.

New

Pilot project about repurposing of medicines

In 2022, a national scientific advice has been provided in the scope of the European pilot project for the repurposing of medicines for new therapeutical 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. Our service also follows the projects for repurposing REMEDi4ALL and REPO4EU in close collaboration with the European workgroup RePog-EU-IN of the STAMP. The aim is to maximise the facilitation of repurposing research of the non-profit sector through scientific-technical advice.

Trend

The number of questions treated yearly by the National Innovation Office and Scientific-Technical Advice Unit keeps increasing. Questions come from the pharmaceutical and medical device industries as well as citizens and healthcare practitioners. We see an increase of 12,8 % compared to 2011. This shows that more stakeholders are finding their way to our service. The recent significant regulatory changes at national and European level also raise many questions.

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FAGG

https://annualreport.fagg-afmps.be