Following the Breakthrough Therapy Designation system in 2012 in the United States, the Sakigake Designation was introduced in 2015 in Japan, and PRIME (PRIority MEdicines) was started in 2016 in the European Union. Each system aims at giving patients better access to innovative drugs and regenerative medicine products by providing product developers with generous regulatory and scientific support from an early development stage. So far, the designation systems have operated independently in each region, and no products with the same indication have been designated commonly under the 3 designation systems. However, no designation system excludes a product designated under another system, which allows the possibility of an applicant to seek all 3 designations; this may happen in the near future. Therefore, an understanding of the current situation under each designation system will contribute to effective operation of each system as well as identification of further collaborative activities between the European Medicines Agency; Japan's Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency; and the United States Food and Drug Administration. Such collaborations can be successful because these organizations have already established a close relationship through international activities such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA).

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Surgery Case reportFemale Asian small-clawed otters (Aonyx cinerea ) in aquariums and zoos might need to be sterilized to prevent reproduction and disease or for pedigree-based genetic management. When performing contraceptive surgery, ovariohysterectomy or ovariectomy via laparotomy is required.However, there is concern that self-injury, such as scratching at the surgical incisions, can lead to numerous complications. Meanwhile, in the field of companion animal medicine, laparoscopic surgery has become extremely popular and has been used for adrenalectomy, cholecystectomy, hepatic lobectomy, and splenectomy [1]. Additionally, laparoscopic ovariectomy and ovariohysterectomy have usually been performed on dogs and cats [2-4]. According to reports, these procedures result in smaller surgical incisions and less postoperative pain [2, 5-7]. Moreover, the incidence of complications is low and length of hospitalization is short [8]. These advantages of laparoscopic surgery are thought to be of great benefit in the ovariohysterectomy of otters. This report describes the surgical procedures, surgical outcomes, and postoperative management of laparoscopic ovariectomy performed on two otters at Osaka aquarium KAIYUKAN. Laparoscopic ovariohysterectomy was performed at the Kanai Veterinary Surgery hospital on two female Asian smallclawed otters from Osaka Aquarium KAIYUKAN. Each otter underwent surgery on a different day. Otter A was a 3.09kg, 10-year-old, and otter B was a 3.88-kg, 9-year-old. Both otters had never given birth due to pedigree-based genetic management. During a biannual health examination under anesthesia, renal calculus was confirmed by radiography and ultrasonography in both otters. Otter B had previously undergone cystolithotomy. However, hematolog ical examination before surgery revealed no abnormalities.Both otters were fasted for 12 h, and water was withheld for 6 h before surgery. On arrival at the hospital, the otters were placed into an induction chamber and sedated with sevoflurane (Sevofrane, Maruishi Pharmaceutical Co., Ltd., Osaka, Japan). They were then weighed and intubated using a 3-mm endotracheal tube. Sedation was maintained with 2.5-3.5% sevoflurane with 100% oxygen (1 L/min) using an anesthesia machine (Apollo, Dräger, Lübeck, Germany), which