Nguva pfupi yadarika, Center for Drug Evaluation (CDE) yeHurumende Chikafu neDrug Administration yakapa chiziviso pa "Technical Guidelines for Pharmaceutical Changes in Marketed Biological Products (Trial)". Iyo nhungamiro ichaitwa kubva pazuva rekuburitswa (Chikumi 25, 2021). Iine zvitsauko zve9 zvinosanganisira mucherechedzo, misimboti yekutanga, zvinodikanwa zvekutanga, shanduko yemaitiro ekugadzira, shanduko yevabatsiri mukugadzirisa, shanduko yezvakatemwa kana kurongedza kurongedza, shanduko yezviyero zvekunyoresa, shanduko yezvinhu zvekurongedza uye midziyo, shanduko yenguva yechokwadi kana kuchengetedza mamiriro. Misimboti inotungamira inoshanda kune zvinodzivirira biological zvigadzirwa, therapeutic biological products, uye in vitro diagnostic reagents inotungamirwa nezvigadzirwa zvebiological, uye kutsanangura pfungwa dzakakosha uye zvinonetsa patsvakiridzo yekuchinja mukunyoreswa uye manejimendi ezvigadzirwa zvebiological mushure memusika.