The Transformation of Inspections Brought by the Pandemic
The COVID-19 pandemic fundamentally transformed how regulatory authorities conduct inspections in the pharmaceutical and medical device industries. In early 2020, travel restrictions were imposed worldwide, making it difficult to conduct in-person inspections that had previously been taken for granted. However, from the perspective of ensuring patient safety, it was not permissible to suspend quality oversight of pharmaceuticals and medical devices. Under these circumstances, regulatory authorities and industry worked together to explore new inspection approaches.
FDA’s Response and Approach
On June 2, 2020, the U.S. Food and Drug Administration (FDA) testified before the Senate Finance Committee under the title “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” In this testimony, the FDA revealed significant changes to its inspection program during the COVID-19 pandemic.
Starting in March 2020, the FDA postponed routine domestic and foreign surveillance inspections, except for mission-critical inspections (such as pre-approval inspections and urgent for-cause inspections). However, the agency did not completely halt inspections but actively utilized alternative oversight methods. These included information sharing with foreign regulatory authorities, leveraging mutual recognition agreements, requesting records from manufacturers, and risk-based sampling of imported drugs (using the PREDICT system).
Notably, the FDA deemed inspections conducted by certain European regulatory authorities as equivalent to FDA inspections and accepted them as substitutes. However, the FDA itself recognized that these alternative methods were merely supplementary and could not fully replace on-site inspections.
Looking at inspection performance in 2020, the FDA was unable to complete more than 1,000 planned inspections, creating a significant inspection backlog. Non-mission-critical foreign inspections did not resume until 2022, and even then, foreign inspections in 2022 were down approximately 79% compared to 2019, while domestic inspections decreased by about 35%. This situation has not fully recovered even through 2024-2025.
Japan’s Response: PMDA’s Introduction of Remote Inspections
Similar transformations occurred in Japan. On May 12, 2020, the Pharmaceutical Evaluation Division of the Ministry of Health, Labour and Welfare issued an administrative notice titled “Handling of Conformity Document-Based Surveys and GCP On-Site Inspections in Response to the Outbreak of COVID-19.”
Through this notification, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) formally introduced “remote inspections” utilizing cloud systems and web conferencing systems. The specific implementation method for remote inspections is as follows.
From June to August 2020, conformity surveys were conducted entirely through remote methods. Subsequently, extensions were repeated depending on infection conditions, and as of 2025, either on-site or remote inspections are selected depending on the content of the survey. For remote inspections, target documents must be stored as electronic files (PDF format) in cloud storage (such as Box or SharePoint). Documents must be submitted two weeks before the inspection date (specifically, by 10:00 AM, 13 business days prior) and provided to inspectors within three days thereafter.
Inspectors review the pre-submitted materials thoroughly, and on the day of the inspection, they conduct questioning primarily from their homes or from within the agency using web conferencing systems (WebEx, Microsoft Teams, etc.). On November 16, 2020, PMDA issued “Procedure for Remote Inspection as Part of Compliance Inspection on Drugs and Regenerative Medical Products” (PMDA Notification), which documented detailed procedures for remote inspections. This was one of the relatively early examples among major global regulatory authorities of publishing remote inspection guidelines in English.
New Challenges Brought by Remote Inspections
Enhanced Transparency and Stricter Compliance Requirements
With the introduction of remote inspections, companies are now required to disclose a broader range of supporting documents in advance compared to traditional document-based surveys. Since inspectors can thoroughly review all relevant materials beforehand, the possibility of “oversights” due to sampling in conventional on-site inspections has been significantly reduced. As a result, the likelihood of receiving findings has increased, and companies are required to establish more sophisticated compliance systems.
This means that corporate operations are in a state of being “transparent as glass.” Therefore, in an environment where remote inspections become mainstream in the New Normal, it is essential to properly maintain and manage daily records and keep them in a state where they can be inspected at any time.
Challenges in Digitizing Paper-Based Records
In conducting remote inspections, various technical challenges arise in the process of scanning paper-based records and converting them to PDF. Specifically, issues such as missing pages, tilted documents during scanning, and partially folded pages are common. Creating perfect scanned data is more difficult than imagined and requires considerable time and effort.
Authorities have indicated a policy of tolerating minor deficiencies in scanned data, provided that paper originals are properly preserved. However, this response is provisional, and companies need to establish long-term strategies. Future operations are expected to diverge in two directions: one is to continue storing paper media and scan as needed; the other is to create and manage records electronically from the outset. The latter involves implementing electronic document management systems (EDMS, eQMS, etc.) and is recommended as a more efficient method suitable for inspection response.
International Trends and the Establishment of Hybrid Approaches
Response of Global Regulatory Authorities
In response to the COVID-19 pandemic, major regulatory authorities worldwide adopted their own approaches while strengthening information sharing and mutual cooperation. The European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Australian Therapeutic Goods Administration (TGA) also developed remote inspection guidelines and established implementation systems.
Among Pharmaceutical Inspection Co-operation Scheme (PIC/S) member countries, sharing of inspection results based on mutual recognition agreements has progressed, thereby improving the efficiency of global pharmaceutical supply chain oversight. However, unlike other regulatory authorities, the FDA conducted virtually no virtual inspections of manufacturing facilities from 2020 to 2021, relying mainly on document reviews (record requests via Form 4003). This was a significantly different characteristic from the approaches of other regulatory authorities.
2024-2025: Establishment of the Hybrid Inspection Model
From 2024 to 2025, regulatory authority inspections have not fully returned to their previous state but have become established as a “hybrid model.” In this model, on-site inspections, remote inspections, and document reviews are combined based on risk assessment.
The FDA recovered to conducting approximately 58% of foreign manufacturing facility inspections in fiscal year 2023, which is equivalent to 2019 levels. However, the number of inspector-days per inspection has been increasing, indicating that more detailed and thorough investigations are being conducted. As a trend in 2025, the FDA has increased the number of warning letters issued in the medical device field, with Corrective and Preventive Actions (CAPA), design controls, and complaint handling being key inspection focus areas.
At PMDA as well, as of 2025, the policy of selecting either on-site or remote inspections depending on the content of the survey continues. In particular, for GCP on-site inspections and conformity document-based surveys at the time of marketing authorization applications, remote inspections have been established as one of the standard methods. Companies are now permanently required to prepare cloud systems for remote inspections, prepare web conferencing environments, and systematically organize advance materials.
Technology Utilization and Future Prospects
Acceleration of Digital Technology Adoption
The pandemic has significantly accelerated the adoption of digital technologies in the pharmaceutical and medical device industries. The adoption of electronic Trial Master Files (eTMF), Electronic Data Capture (EDC) systems, and electronic Quality Management Systems (eQMS) is progressing rapidly. These systems not only facilitate response to remote inspections but also contribute to daily operational efficiency, improved data integrity, and ensuring audit trails.
Furthermore, new technologies such as AI-powered inspection preparation support tools, automated document review systems, and risk-based quality management systems are emerging. On the regulatory authority side, AI-based complaint data analysis, evaluation of adverse event reports, and risk prediction based on past inspection results are being attempted and utilized for prioritizing inspection target facilities.
Future Regulatory Trends
From 2025 onward, regulatory authorities are expected to further evolve their inspection methods in the following directions.
First, further refinement of risk-based approaches will progress. Methods for determining inspection frequency and depth by comprehensively evaluating past inspection history, product types, manufacturing process complexity, and post-marketing safety information will be standardized. Second, the introduction of real-time data monitoring is being considered. Some advanced regulatory authorities have begun attempts to continuously acquire data from corporate quality management systems and detect anomalies early.
Furthermore, further promotion of international harmonization is an important theme. Through the International Council for Harmonisation (ICH) and PIC/S, standardization of requirements is expected to reduce the regulatory burden on global companies. Additionally, integration of sustainability and Environmental, Social, and Governance (ESG) elements into inspections is predicted to advance. Environmental impact of pharmaceutical manufacturing, working conditions, and ethical procurement may be included in inspection items.
Strategic Response Required of Companies
Building a Continuous Compliance System
For companies to succeed in the New Normal, the following strategic initiatives are essential.
First, it is important to systematically advance the transition to electronic record management. Moving away from paper-based record management is not merely digitization but a transformation involving a review of the entire business process. To ensure the authenticity, legibility, and durability of electronic records, it is necessary to build systems compliant with requirements such as 21 CFR Part 11 and ER/ES guidelines (Japan).
Next, continuous training programs must be implemented. All employees need to be educated on remote inspection-specific response methods, effective use of web conferencing systems, and proper management of electronic records. Additionally, it is recommended to regularly conduct mock remote inspections to verify organizational readiness.
Furthermore, forming cross-functional inspection response teams is effective. Teams composed of experts from multiple departments such as quality assurance, regulatory affairs, IT, manufacturing, and clinical development should be formed in advance, and responsibilities for inspection response should be clearly defined.
Cultivating a quality culture is also a long-term important initiative. Compliance should be positioned not merely as regulatory response but as a core organizational value, and a culture where all employees prioritize data integrity and patient safety needs to be built.
Importance of Document Management and Data Integrity
In a remote inspection environment, systematic organization of documents and immediate accessibility are extremely important. Companies need to electronically manage Standard Operating Procedures (SOPs), batch records, deviation reports, change control records, CAPA records, etc., and ensure searchability and traceability.
Data integrity should be ensured based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available). In particular, it is essential that audit trails for electronic records are properly enabled, stored, and regularly reviewed.
Conclusion: Embracing Transformation as an Opportunity
The COVID-19 pandemic fundamentally transformed the nature of inspections in the pharmaceutical and medical device industries. This transformation is not temporary but is becoming established as the New Normal. The introduction of remote inspections and digital technologies began as a crisis response, but is now being actively promoted from the perspectives of improving efficiency, strengthening global consistency, and achieving continuous oversight.
For companies, this transformation is not merely a challenge but also an opportunity to build competitive advantage. Companies that strategically utilize digital technologies, ensure data integrity, and build continuous compliance systems can gain trust from regulatory authorities and strengthen their competitiveness in the market.
Regulatory trends will continue to evolve going forward. New trends such as artificial intelligence, real-time data analysis, and international regulatory harmonization are emerging. Companies need to monitor these changes closely and maintain the ability to respond flexibly.
Ultimately, the essence of inspection response in the New Normal is not achieving formal compliance, but building an organizational culture that truly ensures patient safety and product quality. Maintaining this perspective will be the key to long-term success.
The regulatory trends covered in this article are based on information as of January 2025. Since regulatory requirements are continuously updated, please refer to the official websites and guidance documents of each regulatory authority for the latest information.
Key References:
- FDA: https://www.fda.gov/
- PMDA: https://www.pmda.go.jp/
- EMA: https://www.ema.europa.eu/
- PIC/S: https://picscheme.org/
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