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Efficacy and safety of radiopharmaceuticals It’s all a question of energy intensity

Radiopharmaceuticals are medicinal products that emit radioactive radiation. The effect of radioactive radiation depends on the dosage. It is used beneficially for medical purposes: weak radioactive products for diagnosis, strong ones for targeted destruction of tumour cells. Andreas Fürer, the responsible regulatory manager for radiopharmaceuticals at Swissmedic, explains their efficacy and safety, presents their indications and analyses developments in the sector.

Indications

"Around 50 radiopharmaceuticals are authorised in Switzerland – most of them are diagnostic agents. They’re used to diagnose conditions such as tumours, cardiovascular problems, respiratory diseases or diseases of the central nervous system."

Expert Commission for Radiopharmaceuticals (ECRP)

"They advise the Federal Office of Public Health (FOPH) and Swissmedic on authorisation or variation applications. As both the Therapeutic Products Act and the Radiological Protection Ordinance apply to radiopharmaceuticals, decisions are taken by the FOPH and Swissmedic together. However, the expertise lies with the Federal Council’s Expert Commission for Radiopharmaceuticals (ECRP). This is made up of external experts from universities and hospitals across Switzerland. The applications are reviewed both by us and the FOPH."

Protection against radiation

"The deadly effect of radioactive radiation is due to its energy intensity: One example of non-radioactive radiation is UV radiation, which is highly energy intensive. Long exposure can cause the skin to burn, which we recognise as sunburn. But radioactive radiation is much stronger. At the right dose and using a suitable radioactive isotope, the energy intensity of radioactive radiation can be put to beneficial use in the clinical context – against tumour cells, for example. The rules for handling radioactive substances as well as the relevant limits are defined in the Radiological Protection Ordinance. Also, the same applies to radiopharmaceuticals as to all medicinal products authorised by Swissmedic: they must be safe, effective and of a high quality in all cases."

Marketing authorisation

"To date, applicants have mainly been smaller establishments, such as hospital pharmacies, or else firms specialising in radiodiagnostic agents and large diagnostic equipment manufacturers who also produce radiopharmaceuticals. In general, the collaboration with the various manufacturers is good."

Criteria for authorisation

"The major difference is in protection against radiation, because with these products the dosage (radiation burden) has to be as low as possible while still being effective. Protective measures also have to be defined for medical professionals and the environment. Setting out the requirements for the clinical and preclinical documentation that is required to authorise a radiopharmaceutical is also very specific. Every decision is therefore an individual case – which makes our work both challenging and extremely interesting."

Specialist partner

"We have a close, well-organised and highly flexible collaboration with the Expert Commission and FOPH in relation to radiopharmaceuticals. For the quality documentation, we assess the non-radioactive or 'cold chemical' part, while the radioactive or 'hot chemical' part is assessed by the Expert Commission. Applications are discussed and carefully examined with the Expert Commission at six meetings a year."

"We have a close, well-organised and highly flexible collaboration with the Expert Commission and FOPH."
Andreas Fürer

Networking

"While we work closely with the FOPH, compared to other countries we are currently still at an early stage in our collaboration regarding radiopharmaceuticals. Although therapeutic products legislation has been revised and applies in all EEA states, radiological protection legislation is still a strictly national matter."

Developments in the sector

"Developments in this segment have taken place in relatively calm waters to date. Radiopharmaceuticals have very often been manufactured at university institutes or specialist companies. Radioligand therapy creates the opportunity to use the destructive potential of radioactivity against tumour cells in a targeted way at molecular level. Advances in radioligand therapy over around the past five years have been so interesting that larger pharma firms are also now investing in the development and manufacture of radiopharmaceuticals."

Distribution of roles

"All applications – for authorisations or variations – for radiopharmaceuticals are handled by Swissmedic’s Regulatory Assessment Division. The responsible regulatory manager then decides which applications will be processed by the Expert Commission, which by Swissmedic, and which by the two together. The allocation criteria include administrative or scientific review, and cold or hot chemical."