update

Switzerland to streamline approval process for cross-border inspections

12-Oct-2017 - Last updated on 13-Oct-2017 at 10:33 GMT

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Swiss drug and API manufacturers will soon be able to allow foreign regulators to inspect their facilities without seeking Government approval.

At present all facility inspections conducted by foreign regulators must be approved by the State Secretariat for Economic Affairs (SECO).

However, from January next year active pharmaceutical ingredient (API) and drug manufacturers can consent to audits without seeking approval as a result of changes to the Therapeutic Products Act.

Foreign regulators seeking to audit plants in Switzerland must let Swissmedic know in advance and provide it with an inspection report after the visit.

Swissmedic said: “Swiss companies and foreign authorities will therefore have to make arrangements for inspections with each other” adding it will “notify establishments in good time if it intends to accompany the inspection.”

The agency also said it will notify foreign authorities that have carried out inspections in Switzerland over the last four years of the change.

A Swissmedic spokesman told us "SECO permission was required up to now because Art. 271 of the Swiss Criminal Code prohibited the performance of sovereign activities by foreign authorities in Switzerland unless a special authorisation had been granted by the Federal Council.

"SECO issued such authorisations on behalf of the Federal Council. As the revised Therapeutic Products Act now provides for special, legally admissible arrangements, which were previously absent from therapeutic products legislation, SECO authorisation will no longer be required."

Industry response

Basel-headquartered life science contractor Lonza, which operates several manufacturing plants in Switzerland and has a global customer base, said it will revise its information sheet to reflect the change.

Werner Obexer, Director of Quality Assurance for Lonza Custom Manufacturing, told us “This change is expected to have no impact on the execution of inspections. We will continue to keep Swissmedic informed about any upcoming inspections.

Obexer added that: “By the end of 2017, we expect to have updated our information sheet 'General Procedure for Foreign Government Inspections in Switzerland Related to Therapeutic Products' in order to reflect the new situation."