Saudi FDA Becomes First Arab Member of PIC/S Pharma Inspection Scheme

The Saudi Food and Drug Authority (SFDA) has joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aimed at harmonising inspection procedures worldwide. Through PIC/S membership the SFDA looks to continue bolstering its capabilities and further its international collaboration efforts.

SFDA’s accession to PIC/S is one of the strategic projects of the SFDA’s third strategic plan. It is in line with SFDA’s desire to join global organizations

First Arab Country in the PIC/S

Established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970, PIC/S comprises 54 regulatory authorities from around the world and aims to harmonise their inspection procedures by developing common standards in the field of Good Manufacturing Practice (GMP) and by providing training opportunities to inspectors.

The Saudi authority recently gained membership to PIC/S after meeting its requirements and standards, becoming the first Arab country to be admitted to the group. This new milestone is a confirmation of the SFDA’s commitment to strengthening its capabilities. “This membership will contribute to developing and raising inspectors’ efficiency,” the agency said in a statement.

In addition, the SFDA views PIC/S membership as a means to reinforce the standardisation of its inspection procedures at a state level and extend its international collaboration efforts. “SFDA’s accession to PIC/S is one of the strategic projects of the SFDA’s third strategic plan. It is in line with SFDA’s desire to join global organizations in order to cope with developments in the field of medicine manufacturing and benefit from international inspectorates’ expertise,” said the regulator.

SFDA’s International Ambitions

Since its creation some 20 years ago, the SFDA has put in place three strategic plans and realised its international ambitions by becoming one of the region’s top regulators. “During most of that time, the vision was for the SFDA to be a leading regulator in the region, but we updated this vision because we realized we had already achieved leadership within the region,” said CEO Hisham Bin Saad Al-Jadhey in a 2021 PharmaBoardroom interview. ‘We have our own pharmaceutical standards that are used by other countries within the region. The Gulf Cooperation Council (GCC) countries have a unified GCC Health Council for the registration of medicines and we are the leading regulator in this region,” he added.

The Saudi authority is looking to step up its collaboration with global regulators and Al-Jadhey cited this as one of the SFDA’s priorities. “We have around 14 MOUs signed with different countries, and we are also participating actively in international organizations. For instance, we led the global harmonization working group for medical devices and we are part of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH),” he asserted.

Al-Jadhey linked the agency’s progression and visibility in recent years to investment, claiming that “strong regulations will support industry development and also the internationalisation of domestic companies. As we continue to advance with our initiatives and our regulations strengthen, domestic and foreign companies present in Saudi Arabia will see larger and larger international markets for their products and services.”

Another new member of the PIC/S scheme joining at the same time as the SFDA is Bulgaria’s Bulgarian Drug Agency (BDA).