Overview: Foreign companies must notify the food supplements to the Health Authority (HA) in Mexico which is COFEPRIS. If Foreign companies do not have a

Overview: Foreign companies must register drugs to the Health Authority (HA) in Mexico which is COFEPRIS. If Foreign companies do not have a local subsidiary

Overview: A pre-IND meeting is a formal consultation meeting a sponsor can have with FDA during its drugs’ development program, to clarify some technical questions

Selection & Approval of RLD in China In China, a Reference Listed Drug (RLD) is defined as the first drug approved for marketing in China

공장시설등록이란? 미국에서 의료기기를 상업적으로 판매(수입 및 수출)하기 위해서 행해지는 생산 및 판매 관련되는 등록이며 FDA에 매년 등록이 요구됩니다(Title 21 CFR Part 807).대부분의 공장시설등록(Establishments)시 의료기기와 관련

일본 의약품의 사키가케 지정 2015년 일본후생성(MHLW; Ministry of Health, Labour and Welfare of Japan)은 “사키가케(SAKIGAKE)” 라는 새로운 법률을 공포하였다. 사키가케는 medical unmet needs를 충족시키는 혁신형