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Saudi Regulator Becomes First Arab Member Of PIC/S

Executive Summary

Saudi Arabia’s medicines agency says its membership of the international Pharmaceutical Inspection Co-operation Scheme will contribute to developing and raising inspectors' efficiency.

The Saudi Food & Drug Authority has become a member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), which works towards harmonizing manufacturing inspection procedures worldwide and promoting cooperation between regulatory authorities.

The SFDA’s accession to the scheme is part of the agency’s plan to “join global organizations in order to cope with developments in the field of medicine manufacturing and benefit from international inspectorates’ expertise,” said the agency in a statement.

Some 54 regulatory authorities have joined PIC/S, but the SFDA is the first from an Arab country to do so. The agency applied for PIC/S pre-accession in 2017.  (Also see "Saudi FDA Starts Bid For PIC/S Membership; Philippines Told To Reapply" - Pink Sheet, 10 Aug, 2017.)

Membership will mean that the SFDA can become a reference authority for inspecting pharmaceutical factories. It is also expected to improve efficiency and quality of manufacturing practices of local facilities, which will in turn boost exports of locally manufactured products, commented the agency.

“This membership will contribute to developing and raising inspectors' efficiency through many specialized training programs held by PIC/S periodically, and exchanging inspection information and reports, which in return will help use resources in an optimal manner by targeting high-risk factories through inspection visits,” said the SFDA. “It also helps standardize, at state level, the inspection procedures of pharmaceutical manufacturing practices and activate the rapid alert system at member state level,” it added.

According to PIC/S there are several indirect benefits for industry when relevant authorities become members, including:

  • reduced duplication of inspections;

  • cost savings;

  • more opportunities to export; and

  • improved market access.

PIC/S also points out that authorities that have not joined the scheme accept good manufacturing practice certificates from PIC/S participating authorities. “This means that non-PIC/S authorities and organizations have a greater confidence in medicines manufactured in countries where the regulatory authority is a PIC/S participating authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S membership,” says the scheme.

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