Quality, safety, and efficacy of therapeutical products – IFPMA

IFPMA supports the NRAs’ efforts on convergence – in this case, aligning regulatory requirements over time. This includes leveraging tools available from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and implementing its guidance.

Over the past 50 years, PIC/S has played a central role in facilitating collaboration between countries in GMP inspections. It continues to be a leading platform for countries to jointly address issues related to collaboration in inspection activities and how to adapt to the ever-changing manufacturing environment.

NRAs that become members of PIC/S should find it easier to communicate more openly, exchange information, and benefit from training. PIC/S membership will also help them agree on mutual recognition agreements where appropriate.

Convergence on GMP/GDP standards and related inspection processes is also important to achieve a reliable global supply of quality medicines.

In its position paper on the Convergence of GMPs and inspections, IFPMA encourages NRAs to leverage PIC/S available tools and to implement its guidance, whether they are members or not.