IFPMA contributes industry expertise to developing converged, harmonized norms and standards that enable adequate quality, safety, and efficacy control of medical products globally.

In the past few decades, regional mechanisms and networks intended to harmonize regulations across national boundaries have developed in Europe, Asia, Africa, and Latin America. These mechanisms and networks include the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Coalition of Medicines Regulatory Authorities, International Pharmaceutical Regulators Programme, PIC/S and the World Health Organization (WHO).

As well as actively supporting these networks, we help forge and extend links between harmonization initiatives that strengthen all regulatory systems.

Regulatory reliance is the basis of processes by which a regulatory authority in one jurisdiction considers evaluations performed by another regulatory authority, while remaining responsible and accountable for its own regulatory decisions.

According to the WHO, around 30% of the world’s regulatory authorities “are considered to have the functions required to ensure medicines, vaccines, and other health products work and do not harm patients.”

Regulatory reliance is a response to this challenging situation. It enables regulatory approvals and lifecycle management whilst allowing NRAs to better manage capacity and use resources in a more efficient way. As well as strengthening regulatory networks, implementing regulatory reliance ultimately serves patients by facilitating earlier access to quality-assured, safe, and effective medicines.

IFPMA and our members believe that regulatory systems focused on Africa must be consistent and predictable to make sure people have timely access to quality medicines and vaccines with proven quality, efficacy, and safety.

Weak or absent regulatory systems can often delay the availability of vital medical products for patients on the continent. They can also lead to low quality or fake medical products and inadequate monitoring of side-effects.

The African Medicines Agency (AMA) is a specialized agency of the African Union dedicated to assisting Member States in strengthening regulatory capacity for medical products and health technologies.

For IFPMA and our members, the establishment AMA is a significant step forward when it comes to enhancing regulatory oversight and facilitating access to effective, safe, affordable, quality medicines across the Africa.

Among other things, the AMA has the potential to:

• Allow more focused resources for value-adding activities and making evidence-based scientific regulatory decisions
• Minimize administrative hurdles
• Allow for increased use of reliance-based procedures and harmonized regulatory requirements across Africa, enabling acceleration and simplification of access to medicines and vaccines to patients.

IFPMA encourages all NRAs and healthcare stakeholders to meaningfully engage and advocate for the operationalization of the AMA across African countries. We are also a member of the African Medicines Agency Treaty Alliance, whose mission is to support the rapid ratification and operationalization of the AMA.