Medicines Regulatory Harmonisation

Background 

On 4th – 5th July 2017, IAPO held its 3rd African Regional Meeting. This was an opportunity for the community of IAPO’s African members to come together and call for the establishment of a patient-centric African Medicines Agency. In this respect, it was highlighted how important it is to ensure that patients are placed at the centre of medicines regulatory harmonisation processes.

 

What does regulatory harmonisation mean to patients?

Examples of regulatory harmonisation can be found in various world regions (Europe, Americas, Africa). By pursuing a stronger alignment in terms of standards and regulatory rules, different countries seek to create a more harmonised regulatory environment within which patients can benefit from better and faster access to innovative medicines. However, in order for this process to fully and successfully tackle patients’ real needs, it must build on strong and meaningful patient engagement.

Some world areas, for example Europe, have already put in place established mechanisms of patient engagement in the activities carried out by their regulatory agencies. Other areas, for example Africa, are in the process of launching their own agencies, which represents an important opportunity for patients to be part of this conversation from the start.

 

Policy briefing 2017

IAPO believes there are three key messages that patient advocates can draw on to emphasise the value of structured patient engagement in harmonisation mechanisms and processes:
  • Patient engagement in regulatory harmonisation must take place as early as possible and be nurtured over time;
  • ​“Leave no-one behind” means more than access to medicines;
  • Harmonising does not mean ignoring differences.

Read the policy briefing here.

 

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