Swissmedic’s Guidnace: Understanding the Procedure With Prior Notification (PPN) and Environmental Conditions for Microbiological Examination of Non-Sterile Products

As regulatory systems evolve globally, Switzerland continues to harmonize and strengthen its medicinal product oversight through guidance that combines scientific rigor with procedural clarity. Two recent Swissmedic documents—the guidance on the Procedure with Prior Notification (PPN) and the technical interpretation on environmental conditions for microbiological examination of non-sterile products—together illustrate how Swiss authorities aim to improve both regulatory efficiency and laboratory quality standards. Although these guidances address different domains, both reinforce a regulatory framework grounded in predictability, transparency, and risk-based control.

Swissmedic’s PPN Procedure — A Structured Pathway to Faster Review

Procedure With Prior Notification (PPN) applies to first authorizations of NAS products, Art. 12 para. 5 TPLO preparations, or additional indications/pharmaceutical forms submitted alongside NAS applications, requiring complete clinical/preclinical data at submission including EMA/FDA reports.

Requests, submitted 3-6 months pre-application, detail the active substance, indication, pivotal studies, and exact submission date (±2 weeks); Swissmedic approves within 30 calendar days if resources allow, with optional pre-submission meetings to align on documentation like indices and sample testing. Post-approval, applications in eCTD/eDok format undergo formal checks (10 days), evaluation phases (110/200 days total, shortened), LoQ replies, preliminary decisions, and labeling phases, with failure to meet deadlines reverting to standard procedures and full fees.​

• Key conditions: No incomplete data; exact submission date mandatory 1 month prior.

• Timelines: New authorizations (264 days total); extensions (216 days).

• Fees: Double per Art. 7 FeeO-Swissmedic; hourly for early withdrawal.

Swissmedic also notes that if the applicant submits excessive or unsolicited documentation unrelated to the specific questions raised, the Agency reserves the right to extend the evaluation period and charge additional fees based on the workload generated. In all cases, the guidance makes clear that PPN accelerates timeline expectations for both parties and requires precise coordination to be successful.

 Environmental Conditions for Microbiological Examination — Ensuring Integrity of Non-Sterile Testing

The second Swissmedic document—the Environmental Conditions for the Microbiological Examination of Non-Sterile Products—is a technical interpretation intended to harmonize how inspectors and laboratories apply the European Pharmacopoeia (Ph. Eur.) standards during microbiological testing. It emphasizes that laboratories conducting such testing must operate under environmental conditions that minimize both extrinsic contamination and inadvertent inhibition of microbial growth. Swissmedic explains that inadequate environmental control can mask low-level bioburden, suppress slow-growing organisms, or lead to false-positive contamination events.

The guidance describes that certain analyses, such as microbiological monitoring of water for injection or tests conducted immediately before sterile filtration, require particularly stringent conditions. Swissmedic states that these activities should be performed within a laminar airflow (LAF) cabinet equipped with a HEPA filter to ensure that the testing area does not introduce contamination to samples with very low microbial acceptance limits. At the same time, the guidance emphasizes that laboratories must avoid environmental conditions that inhibit microbial recovery, since testing must reflect the actual microbial load of samples.

The guidance clearly states that microbiological laboratories must be physically separated from production areas to prevent cross-contamination. The environmental layout should prevent airflow from production spaces into laboratory rooms, and access must be restricted through appropriate controls. Swissmedic also explains that microbiological laboratories must further separate “clean” operations—such as handling of test samples—from “live culture” activities that involve inoculated organisms, subculturing, or identification procedures. If complete room separation is not feasible, laboratories must use risk-based barriers, such as dedicated LAFs, to prevent cross-contamination.