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

unmet medical need programmes submitted

unmet medical need programmes closed

reassessments of approved medical need programmes

substantial amendments to unmet medical need programmes submitted

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

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

performance studies with in vitro diagnostics in accordance with the new Regulation (EU) 2017/746 (from 26 May 2022)

performance studies with in vitro diagnostics in accordance with the old legislation EU directive 98/79 (until 25 May 2022)

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

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

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

632

files closed

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 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

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

files closed

Herbal medicines

new applications for a marketing authorisation or a registration

variations

five-yearly renewals

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

applications for clinical trials

Files for obtaining marketing authorisation

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

new authorisation application via the mutual recognition procedure or the decentralised procedure file with Belgium as reference Member State

authorisation application via the national procedure with Belgium

applications for European scientific advice with Belgium as rapporteur or co-rapporteur

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

assessment reports for compassionate use or medical need programmes

101

national and European scientific advice files

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

European scientific advice documents

evaluation reports for new marketing authorisations

evaluation reports for type II-variations

Medical Devices

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

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

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

Simultaneous national scientific advice

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

portfolio meetings

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

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

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

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.