Mexico
Multidisciplinary group for drug security and quality
The multidisciplinary group for drug security and quality, composed of Asociación ALE, Asociación Mexicana de Lucha contra el Cáncer, Red de Acceso, Asociación Mexicana de Familiares y Pacientes con Artritis Reumatoide, Unidos Combatiendo la Esclerosis Múltiple, wrote in 2013 a manifesto about biotechnological and biocomparable medicines, pharmaco-vigilance and patient organizations’ involvement.The development of biotechnological and biocomparable medicines was presented in an accelerated manner, so it is important that Mexican legislation has the necessary elements to ensure patient safety in relation to the approval of these drugs.
The development of biotechnological and biocomparable medicines was presented in an accelerated manner, so it is important that Mexican legislation has the necessary elements to ensure patient safety in relation to the approval of these drugs.
The group advocate:
- To strengthen the current legislation under review (NOM-NOM-177 and 257), to ensure the safety and effectiveness of biocomparables innovative biotech drugs.
- Not to allow replacement therapies due to the risk of immunogenicity and the difficulty to ensure the monitoring, in terms of safety and efficacy.
- To promote the culture of patient safety and pharmacovigilance by involving patients' organizations in decision making bodies and policy implementation.