What is Cadifa Brazil?

At the end of a successful review, the DIFA holder will receive a certificate of suitability from ANVISA. This certificate is called a CADIFA (Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo) which is equivalent to the Certificate of Suitability (CEP) in Europe.

What is Cadifa filing?

According to the agency, the DIFA (Active Pharmaceutical Ingredient. dossier) must be submitted to Anvisa by the DIFA holder to receive a. CADIFA (letter of suitability of the active pharmaceutical ingredient). It shows the compliance of a DIFA with the regulatory requirements.

What is the Mexican FDA called?

The Mexican Secretariat of Health (Spanish: Secretaría de Salud) is the agency in charge of the national health policy and other aspects of health services, including regulating drugs and medical devices.

Who founded ICH?

The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.

Does Mexico have an FDA equivalent?

Does FDA apply to Mexico?

Established in April 2009, FDA’s Latin America Office serves as the lead for FDA’s on-site presence in the 44 countries and territories that span Latin America, Central America, the Caribbean and Mexico.