Table of Contents
What is Cadifa Brazil?
A CADIFA is a letter from ANVISA showing that a DIFA, which is a certain DMF together with other administrative documents, was evaluated by them and considered suitable to be part of the composition of any drug product in the market.
What is a clinical trial Authorisation?
Clinical Trial Approval in Europe. To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion.
Who approves a clinical trial?
FDA
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community.
Where is MHRA based?
10 South Colonnade, London E14 United Kingdom
Medicines and Healthcare products Regulatory Agency
| Executive agency overview | |
|---|---|
| Headquarters | 10 South Colonnade, London E14 United Kingdom |
| Minister responsible | Lord Bethell, Parliamentary Under Secretary of State (Minister for Innovation) at the Department of Health and Social Care |
Does Mexico have an FDA equivalent?
The FDA and the agencies responsible for food safety regulation in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) – have a long history of working together.
What is Cofepris certificate?
Certificate of Free Sales released by COFEPRIS As any other National Regulatory Agency (NRA), COFEPRIS issues Certificates of Free Sales to allow national manufacturers meeting other agencies requirements, or as part of the importation process in the country of destination.
What is the RDC 48?
RESOLUÇÃO – RDC Nº 48, DE 25 DE OUTUBRO DE 2013 Aprova o Regulamento Técnico de Boas Práticas de Fabricação para Produtos de Higiene Pessoal, Cosméticos e Perfumes, e dá outras providências.
What does ANVISA do?
International inspections to verify Good Manufacturing Practices Anvisa conducts international inspections to verify Good Manufacturing Practices in companies that manufacture Drugs, Medical Devices and APIs that are to be imported and marketed in Brazil.
What is an ANVISA GMP certificate?
Anvisa conducts international inspections to verify Good Manufacturing Practices in companies that manufacture Drugs, Medical Devices and APIs that are to be imported and marketed in Brazil. A valid GMP certificate is a requirement for Anvisa to issue a market authorization for these products.
What are the RDCs for pharmaceuticals?
Resolution RDC 17/2010 Radiopharmaceuticals Resolution RDC 63/2009 Herbal products Resolution RDC 13/2013 Medicinal Gases Resolution RDC 69/2008 Active Pharmaceutical Ingredients Resolution RDC 69/2014 (GMP) and RDC 204/2006 (Good Distribution and Fractionating Practices for Pharmaceutical Supplies) Pharmaceutical Excipients Resolution RDC 34/2015