Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Critical Assessment - Implementation of ICH Guidelines in Brazil ***

Lais da Silva (Abschlußjahr: 2018)

Summary
Language: English
In November 2016, The Brazilian National Agency for Health Surveillance (Agência Nacional de Vigilância Sanitária - ANVISA) became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Brazil was the first country in Latin America to join the ICH as a member, and together with South Korea, were the first two countries to be accepted into ICH as regulatory members. Joining the ICH, the agency has to fulfil with some obligations such as implementation of guidelines. As a commitment, within five years, ANVISA should adopt a set of five ICH guidelines that mainly concerns the Quality, Pharmacovigilance, Clinical Research, implementation of the Common Technical Document (CTD) and Medical Dictionary for Regulatory Activities (MedDRA).
The thesis provides a critical assessment to implement the ICH guidelines in Brazil, with focus on the ICH guidelines for stability testing ICH Q1 and for the Common Technical Documents ICH M4, for registration of new medicinal products. Both guidelines have been selected due to major differences between the current Brazilian regulations and ICH guidelines, leading to a huge challenge for the Brazilian Health Authority and the locally established Pharmaceutical Companies to implement these guidelines. Although many differences still in existing and efforts will be needed to implement the ICH guidelines in Brazil, ANVISA is putting a lot of efforts to implement the guidelines within the next years, in an open communication with the Industries, in order to reduce as much as possible, the impact.
The implementation of the ICH guidelines will bring many benefits for the Industry and Regulator. By implementing the ICH guidelines in Brazil, the country will contribute to the global regulatory harmonisation, which will bring a great benefit to the public health and important medicines will be faster available to the patients.
Pages: 58