Good manufacturing practices (GMP) are the foundation of pharmaceutical quality systems and ensure that medicines are consistently produced and controlled according to established quality standards.

IFPMA and its member companies uphold robust GMP across the full manufacturing lifecycle.

As pharmaceutical manufacturing has become increasingly globalized, national regulatory authorities (NRAs) face growing demands, including a rising number of pre approval inspections and routine good manufacturing practice (GMP) and good distribution practice (GDP) inspections conducted by both domestic and foreign authorities.

These pressures make it essential to use regulatory resources efficiently while maintaining strong oversight.

Inspections are part of the overall quality assurance system for medicines. They assess manufacturing capability, processes and controls, facilities, and quality management systems, and support oversight of product quality across global supply chains.

With increasingly globalized manufacturing, a resource-efficient approach to inspection programs should focus on sites presenting the greatest potential public health risk. Cooperation, information sharing, and regulatory reliance between NRAs help broaden inspection coverage, reduce duplication, and enable a more risk-based use of resources. When applied appropriately, digital and remote tools can complement on site inspections, increase flexibility, and support continuity of regulatory oversight.

To strengthen manufacturing quality and inspection systems globally, IFPMA advocates for:

• The consistent application of robust Good Manufacturing Practices (GMP) to ensure medicines are produced and controlled to the highest quality standards.
• Alignment with internationally recognized GMP standards, including those supported by the Pharmaceutical Inspection Co‑operation Scheme (PIC/S), to promote trust, information exchange, and a common understanding of inspection outcomes among regulators.
• Regulatory convergence over time, supporting greater consistency and predictability in inspection expectations across jurisdictions.
• Risk‑based and reliance‑based inspection approaches, enabling NRAs to focus resources on sites presenting the greatest potential public health risk while reducing unnecessary duplication.
• Transitioning GMP inspection reliance from pilots to routine practice, by integrating lessons learned into standardized pathways that allow NRAs to leverage inspection evidence from PIC/S participating authorities, optimize regulatory resources, strengthen supply resilience, and fully retain national regulatory sovereignty.
• Use of PIC/S tools and guidance, as encouraged in IFPMA’s position paper on the Convergence of GMPs and Inspections, whether or not authorities are PIC/S members.

Quality control is an important element of a country’s regulatory oversight.

IFPMA encourages a risk‑based approach to in‑country quality testing, with a primary focus on post‑marketing surveillance. Such approaches help ensure product quality without introducing unnecessary delays to supply and support the detection of falsified or substandard medicines in local distribution channels.

Where products are manufactured and distributed in compliance withGMP and GDP, routine import testing is considered redundant. Available evidence indicates that import testing does not provide additional quality or safety benefits under these conditions, while it can delay supply and strain regulatory resources.

Greater collaboration among NRAs, including reliance on testing performed by trusted networks of regional quality control laboratories, can help eliminate duplicative testing, improve efficiency, and accelerate patient access to medicines.

The routine use of physical product samples for quality control testing should be minimized, particularly for innovative and complex products, in order to preserve product availability for patients and improve regulatory efficiency.

Applying risk‑based criteria can help determine when physical samples add genuine regulatory value.

To support a more risk-based and efficient approach to quality oversight, IFPMA has illustrated how reducing routine or duplicative sample testing, particularly for post-approval changes, can preserve product supply, ease the burden on regulatory authorities, and focus resources on activities that genuinely contribute to quality assurance and patient safety.

More information on this topic, including IFPMA recommendations on import testing, in-country testing, and in-country testing for ATMPs, is available in different languages.

Post-approval changes (PACs) to the registered information of authorized products are routinely introduced globally to help enable a robust, efficient manufacturing process.

PACs support robust and efficient manufacturing processes, help maintain reliable and timely supply, enable continuous improvement of quality control techniques, and allow manufacturers to respond to evolving regulatory requirements and upgrade to state‑of‑the‑art technologies and facilities.

In an increasingly globalized manufacturing environment, the implementation of PACs can be challenging. Differences in regulatory requirements, data expectations, and review timelines across jurisdictions – combined with complex global supply chains – can lead to unpredictability and delays, with potential implications for supply continuity.

IFPMA believes that greater global regulatory convergence, including work sharing among national regulatory authorities (NRAs) and the use of reliance‑based processes, can create a more efficient and predictable framework for the management of PACs worldwide. Such approaches help ensure continued patient access to quality medicines and up‑to‑date product safety information.

To support efficient lifecycle management, IFPMA advocates for:

• Globally convergent approaches to the management of post‑approval changes, reducing variability in regulatory expectations across jurisdictions.
• Work sharing and reliance‑based regulatory processes among NRAs to improve efficiency and predictability in PAC implementation.
• Tiered, risk‑based classification systems for PACs, based on principles outlined by the World Health Organization (WHO).

Regulatory frameworks that enable timely implementation of PACs, particularly for complex and innovative products.

IFPMA member companies conduct high quality, science-driven studies to develop innovative medicines for patients in need and vaccines for use in healthy populations.

Studies are carried out according to international regulatory and ethical standards such as the Declaration of Helsinki and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Companies also carry out research in compliance with national regulations and ethical requirements.

Our members are fully committed to enhancing public health by sharing clinical data responsibly and making clinical trial results available.

Companies provide access to trial results data for the benefit of public health. For example, biopharmaceutical companies routinely collaborate with academic researchers, publish their clinical research in peer-reviewed literature, and share clinical trial information including results on public websites.