IAPO at the Mutual Recognition Agreements and Reliance in the Regulation of Medicine Meeting

Thursday, 18 July 2019

Calling for global medicines regulatory coherence

 

In light of rapid globalisation of pharmaceutical research, development, manufacturing, distribution and trade, it is becoming clear that no one regulator has the capacity to regulate all the new medicines and health devices seeking authorisation every year. 

A committee of the National Academy of Sciences convened a meeting on 10th July 2019 at the Gates Foundation in London bringing together regional and national medicines regulatory bodies to review and assess the use of Mutual Recognition Agreements and informal practices of Regulatory Reliance.

This would allow regulators to use information from their counterparts at foreign drug regulatory agencies, in medicines regulation. This would also guarantee patients having early access to quality and safe products as manufacturers would only be required to submit their medicine’s dossier for inspection to one agency with  a recognised regulatory framework.

Participants included regional regulators like the US Food and Drug Administrator (FDA) , European Medicines Agency (EMA) and African Medicines Agency (AMA) joined by the national drug regulators from New Zealand, Australia and UK. Additionally, non-State actors like International Federation of Pharmaceutical Manufacturers and International Alliance of Patients’ Organizations were also present with IAPO leading the patient group stakeholder unit. 

Leading the patient group stakeholder unit, IAPO CEO, Kawaldip Sehmi highlighted the need to improve global regulation coherence as this would guarantee patients having early access to quality and safe products as manufacturers would only be required to submit their medicine’s dossier for inspection to one agency with  a recognised regulatory framework.

 

Read Kawaldip Sehmi's report here