The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)made the comments earlier today ahead of a conference for industry and regulatory experts and the World Health Organisation (WHO) that it is holding in Lima, Peru this week.
IFPMA told in-Pharmatechnologist.com “harmonized regulations would help to ensure the overall quality, safety and efficacy of medicines in a given region and secondly, would provide patients with faster access to new or improved medicines as the registration process may be initiated easily in parallel in different countries.”
The view is in keeping with those of other drug industry organizations which - when calling for any type of policy change - emphasize the potential benefits for patients rather than for their members.
So with this in mind we asked why harmonised regulations in South America would impact patients and why – for example - someone receiving medication in Chile would care about the regulations governing medicines in Peru.
In response the IFPMA said: “Harmonized regulations would also give patients security in knowing that the medicine they purchase in one country is of the same quality and efficacy as the medicine they purchase at home, for example in cases when an individual or patient might be traveling.”
Industry
The travelling sick aside, harmonization between South American countries would also be good for industry according to the IFPMA because it will allow manufacturers to complete one global or regional dossier allowing for quicker and more streamlined registration processes.
“Due to differing timelines and data requirements at the country-level for post-approval modifications, implementation times for quality improvements to medicines can be increased and therefore delay patient access. “
Various organizations – primarily the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the International Conference on Harmonisation (ICH) - have been working to create aligned regulations in South America for nearly two decades.
IFPMA acknowledged that these efforts are ongoing, but said that “Such activities take time and are dependent upon the capacity and training of individual national regulatory authorities.
As an interim measure it suggested that: “[South American] countries could rely on “mutual recognition” systems for inspections and registration processes from reference regulatory authorities in order to license medicines.”