- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > health hazard evaluation
- Palabras clave > pharmacovigilance
- Palabras clave > product assessment
- Palabras clave > product recall
- Palabras clave > Product withdrawal
- Palabras clave > products not approved
- Palabras clave > reporting
- Palabras clave > safety
- Palabras clave > side effect
- Palabras clave > effet indésirable
(2006; 18 pages)
Safety of medicines is a core responsibility of the manufacturers and distributors of medicines. The responsibility is shared with the Pharmacy and Poisons Board.
Recognizing that information obtained prior to first marketing is often inadequate to cover all aspects of drug safety and that tests in animals are at times insufficiently predictive of human safety; and taking into consideration that clinical trials may not completely replicate what happens in clinical practice, it is prudently expected that more information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions may emerge regarding drugs which are already authorized for use. These, combined with the fact that defects may emerge during manufacture or storage of the products make it necessary for stakeholders to be prepared to conduct product recall or withdrawal if and whenever need arises. These guidelines have been prepared to assist stakeholders in dealing with such issues and define how the Pharmacy and Poisons Board would manage such eventualities as well as the role of the affected companies.
I trust that the cooperation and timely action by stakeholders, in this regard, will go a long way in upholding safety of medicines at all times.