News and Educations

HRPRES2020: HALMED hosted the virtual joint meeting of the CHMP and SAWP


As part of the Croatian Presidency of the Council of the European Union, on 17 June 2020 Croatian Agency for Medicinal Products and Medical Devices (HALMED) hosted the joint meeting of the Committee for Medicinal Products for Human Use (CHMP) and the Scientific Advice Working Party (SAWP). Due to the COVID-19 pandemic, the meeting was held virtually.

The meeting was chaired by Margareta Bego, MPharm, Univ.Mag.Pharm., HALMED, Croatian member in CHMP, who welcomed participants and announced lectures relevant to the work of both CHMP and SAWP. In addition, Selma Arapović Džakula, MD, HALMED, Croatian CHMP alternate, Prof Livia Puljak, MD, PhD, Croatian member in SAWP and Adriana Andrić, MD, MPH, HALMED, Croatian SAWP alternate, actively participated in the meeting.

Approximately 100 participants attended the meeting, including members of CHMP and SAWP, and the European Medicines Agency (EMA).

During the joint part of the meeting, the presentations were held by invited lecturers Prof Sven Lončarić, PhD, University of Zagreb, Faculty of Electrical Engineering and Computing, and Prof Sebastian Schneeweiss, MD, ScD, Harvard University, USA. Prof Lončarić presented the process of development of artificial intelligence (AI) in medicine, while Prof Schneeweiss covered the challenges of using the real-world data in adoption of regulatory decisions.

Nikolai Brun, MD, PhD, of the Danish Medicines Agency (DKMA), and Peter Arlett, MD, of the European Medicines Agency (EMA), presented ten recommendations for the Big Data Task Force (BDTF). The need for a rational implementation of Big Data into the medicines evaluation was emphasised, for which appropriate and accessible expertise in the EU Network is crucial.

During the separate part of the meeting, CHMP participants discussed the role of the rapporteurs in the procedures covered by the EMA’s priority medicines authorisation scheme (PRIME) and the need to develop a practical guidance document for rapporteurs. It was emphasised that an assessment of the five-year PRIME scheme experience will be conducted in 2021. Likewise, the development of the Guideline on Summary of Product Characteristics (SmPC) section 5.1 was discussed, as well as the future activities for reaching harmonized conclusions on that issue. In addition, an update status of the ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) document was presented.

During the SAWP part of the meeting, participants discussed potential operative measures to improve the process of providing scientific advice, in relation the continuous growth in the number and complexity of requests for scientific advice. The measures discussed relate to plenary discussions, late reports, debriefings and peer-review. EMA’s new e-system Regulatory & Scientific Information Management Platform (IRIS) was presented, which has been planned to enable the work and search option on reports and documentation related to scientific advice, as of September 2020.

CHMP chair, Harald Enzmann, MD, of the German Federal Institute for Drugs and Medical Devices (BfArM), and SAWP chair, Anja Schiel, PhD, of the Norwegian Medicines Agency (NoMA), thanked HALMED’s representatives for organising the meeting, which is important for the continuity of work and the development of further cooperation between CHMP and SAWP.

The participants evaluated the meeting as very successful and expressed their satisfaction with the selected topics, valuable discussions and great interactivity that was achieved despite the meeting being held virtually.


Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for evaluation of centralised procedures applications, monitoring the safety of medicines approved by centralised procedures, deciding on emergency warnings for drug restrictions, approves information on medicines, provides European public assessment reports (EPAR), provides scientific advice to companies researching and developing new medicines, prepares scientific guidelines and regulatory guidance to pharmaceutical industry, cooperates with international partners on the harmonisation of regulatory requirements, conducts arbitration proceedings for MRP/DCP and participates in arbitration proceedings important to public health. The Committee consults working groups that provide an expert support in their scientific field, and the members of the Committee are representatives of the EU member states, who are experts in certain scientific fields.

Scientific Advice Working Party (SAWP) is the CHMP’s working group that provides scientific advice on various issues related to the development of medicines, including quality of medicinal products, non-clinical and clinical safety and efficacy, as well as the significant benefit of orphan medicinal products. Specific areas for which this multidisciplinary group provides scientific advice include non-clinical safety, pharmacokinetics, methodology and statistics, and therapeutic fields for which are frequent requests, such as cardiology, oncology, diabetes, neurodegenerative disorders and infectious diseases.