Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ For clin­ic­al tri­als of medi­cin­al products, the Agency shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the safety of the medi­cin­al product, and in par­tic­u­lar the pre­clin­ic­al and clin­ic­al phar­ma­co­logy, tox­ic­o­logy, for­mu­la­tion and phar­ma­cokin­et­ics, and the pro­posed dosage and in­dic­a­tion;

c.

the risk as­sess­ment and risk man­age­ment based on the medi­cin­al product safety data;

d.

the qual­ity of the medi­cin­al product and com­pli­ance with Good Man­u­fac­tur­ing Prac­tice (GMP);

e.

oth­er areas, where this is ne­ces­sary to as­sess the safety or qual­ity of the medi­cin­al product.

² For Cat­egory B clin­ic­al tri­als of medi­cin­al products cap­able of emit­ting ion­ising ra­di­ation, it shall ad­di­tion­ally re­view com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion.

³ For clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA, it shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the re­quire­ments spe­cified in Art­icle 54 para­graph 4 let­ter b TPA.