Overview and Background
PIC/S stands for the “Pharmaceutical Inspection Convention / Co-operation Scheme.”
PIC/S refers to two international arrangements among countries and their medicines inspection authorities (PIC = Convention, PIC Scheme = Co-operation Scheme). Its purpose is to strengthen cooperation among national regulators in the field of GMP (Good Manufacturing Practice) for medicinal products.
In short, it is a framework that harmonizes international standards for GMP inspections (factory audits) related to pharmaceutical manufacturing and quality control, and enables the mutual recognition of inspection results.
PIC/S has a long history. The first PIC (Pharmaceutical Inspection Convention) was concluded in 1970 under the leadership of the European Free Trade Association (EFTA) as an agreement among ten EFTA members to mutually recognize inspection results of pharmaceutical manufacturing sites.
The need for a more flexible mechanism, open to broader participation, led to the creation of PIC/S (the joint inspection scheme) in 1995. PIC/S is not a legally binding treaty but an informal understanding among authorities; it is operated as a private organization under Swiss law.
As of 2021, PIC/S comprised 52 member authorities, including many European regulators as well as authorities from Canada, Australia, Singapore, Korea, Taiwan, Malaysia, Indonesia, Thailand, and others around the world.
Main Requirements and Criteria
PIC/S functions as a kind of club; to join, national regulatory authorities must meet certain criteria.
Accession assessments evaluate whether an authority’s GMP inspection system meets international standards. Specifically, examiners review inspector qualifications and training systems, inspection procedures, the status of GMP standards (regulations), and historical inspection performance; existing members then decide on accession.
Accordingly, PIC/S member authorities can be regarded as organizations that have met stringent benchmarks for inspection capability.
Among PIC/S members, the following arrangements apply:
Mutual Recognition of Inspection Results
GMP inspection results issued by one member authority can be accepted as valid by other member authorities. This reduces the need for multiple authorities to conduct duplicative inspections of the same site, lessening burdens for both manufacturers and regulators.
Whether recognition extends to full reliance for domestic approval depends on bilateral arrangements; nonetheless, participation in PIC/S lays the groundwork for such mutual reliance.
Harmonization of Inspection Methods
Inspectors share common inspection procedures and best practices to maintain a consistent level of inspection across countries.
In practice, PIC/S publishes inspection guides (e.g., the PIC/S GMP Guide, which is effectively equivalent to the EU GMP Guide), and standardizes inspection checklists and inspector handbooks.
Information is also exchanged on areas of emphasis during inspections (risk-based approaches, evaluation of pharmaceutical quality systems, etc.), aiming for a situation where inspectors from any country can inspect with minimal variation.
Training and Exchanges for Inspectors
PIC/S regularly organizes training programs, mutual exchanges, and Expert Circles for inspectors from member authorities.
Thematic workshops—such as on aseptic manufacturing inspections or computerized systems inspections—allow countries to share challenges and lessons learned, fostering inspector upskilling and professional networks.
Harmonization of GMP Standards
PIC/S also promotes convergence of national GMP standards. Members are encouraged to adopt the PIC/S GMP Guide as their national standard; in practice, the EU’s GMP framework is highly aligned with the PIC/S Guide.
By unifying written standards, manufacturing sites can be evaluated against the same criteria regardless of country.
Information Sharing and Cooperation
Inspection-related information is exchanged smoothly among member authorities. For example, when a serious GMP deficiency is identified at a site, that information is shared via the PIC/S network, enabling corrective actions across other jurisdictions as needed.
In emergencies, joint inspections may be organized, and technical assistance may be provided to non-member countries.
Through these activities, PIC/S aims to build a “globally harmonized, high-level GMP inspection system.” Member authorities undergo periodic peer assessments to maintain standards, and applications for new membership are carefully evaluated.
In other words, PIC/S serves as a practical platform that supports international standardization of pharmaceutical GMP at the operational level.
Significance and Benefits of Membership
While PIC/S membership is primarily a status for regulators, its significance reaches across the entire pharmaceutical sector.
For member authorities, participation is proof of being a globally trusted inspection authority. The accession process itself provides opportunities to review and improve inspection systems, ultimately raising national GMP oversight standards.
After joining, authorities can leverage current information and training from the PIC/S network, supporting inspector capability and morale. These benefits directly contribute to public health by improving the quality of medicines within their jurisdictions.
Manufacturers also gain numerous advantages from the PIC/S framework.
One is the reduction of duplicative inspections. Because member authorities can share inspection results, inspections conducted in one region may be referenced by others, allowing on-site inspections to be waived or streamlined in some cases.
This reduces repeated preparation and lowers inspection-related costs. For companies with multiple global sites, supplying products to PIC/S countries becomes smoother.
Furthermore, harmonized GMP standards under PIC/S make it easier for companies to build consistent quality systems. As requirements converge across jurisdictions, organizations can apply unified policies to global operations.
This not only improves the efficiency of quality management but also enables internationally consistent quality assurance—“the same quality regardless of manufacturing location”—enhancing brand value. In addition, member authorities often provide guidance and education domestically, helping to raise GMP standards across the industry.
Ultimately, higher pharmaceutical quality supports exports and builds trust in international markets.
For patients and clinical practice, PIC/S improves access to safe, high-quality medicines. Close collaboration among authorities helps prevent distribution of substandard products and enables rapid recalls, while maintaining a baseline of quality regardless of country of origin.
Adopting PIC/S practices in regions with limited inspection resources also helps curb the circulation of falsified or poor-quality medicines. Overall, membership is a strong example of international cooperation that benefits regulators, industry, and consumers alike.
Impact on Products, Services, and Consumers
Although PIC/S is an institutional framework, its effect reaches consumers as assured quality of medicines in the marketplace. Products manufactured under PIC/S member oversight are confirmed to meet stringent international inspection standards.
Consumers (patients) using such medicines can expect consistently adequate quality and safety. For example, even when a generic manufactured in one country is exported to another PIC/S member, its quality system can be trusted to be on par with that in the country of manufacture.
This alleviates concerns about the quality of imported products and supports confidence in treatment.
From a service perspective, PIC/S also helps accelerate international rollout of new medicines. Historically, launches in some countries awaited completion of site inspections by local authorities; mutual reliance via PIC/S can allow one inspection to satisfy multiple countries’ requirements.
This increases the likelihood that breakthrough medicines, once launched in one market, can be accessed promptly in others. For patients, it means earlier access to innovative and high-quality generic medicines, expanding therapeutic options.
PIC/S also encourages continual quality improvement at manufacturing sites. Frequent information exchange among inspectors spreads best practices, enabling other companies to adopt them.
Conversely, when deficiencies are identified, international alerts prompt facilities with similar risks to take corrective actions. As standards rise across the industry, the overall quality of medicines improves, so consumers gain access to safer products.
For healthcare professionals, sharing regulatory information and alerts through PIC/S makes it easier to track overseas issues affecting products in domestic circulation and to take precautions in patient care. This supports appropriate use of medicines and patient safety.
In short, even if not directly visible to consumers, PIC/S substantially advances the ideal that “medicines are safe to use no matter where they are manufactured.”
Relevant International Bodies and Regulators
PIC/S is an independent organization headquartered in Geneva, Switzerland, with membership primarily comprising national medicines regulatory authorities.
In Europe, many EU national authorities (e.g., ANSM, BfArM) and the EMA participate; in the United States, the FDA participates as an observer. Across the Asia-Pacific region, members include MFDS (Korea), TFDA (Taiwan), HSA (Singapore), NPRA (Malaysia), BPOM (Indonesia), Thai FDA (Thailand), TGA (Australia), and Health Canada (Canada). Member authorities form the PIC/S Committee and set policy at annual meetings and other fora.
As related international organizations, the WHO participates in PIC/S as an observer, cooperating on support for developing countries and strengthening vaccine inspection capacity.
The European Union shares the same objectives; the EU’s GMP standards and inspection system are fully harmonized with PIC/S guidelines. In practice, the PIC/S GMP Guide is the EU GMP Guide, and revisions are coordinated.
Industry associations (e.g., PhRMA and others) also cooperate with PIC/S by providing trainers and facilitating information exchange.
Additionally, the International Council for Harmonisation (ICH) and the International Society for Pharmaceutical Engineering (ISPE) are indirectly involved in PIC/S activities.
For example, PIC/S has adapted the ICH Q7 Guideline (API GMP) into training materials, and works with ISPE/PDA to share guidance on data integrity.
Thus, PIC/S acts as a hub that advances harmonization of global GMP oversight systems in collaboration with national authorities and related international organizations.